{
  "code": "LRK",
  "deviceName": "Device, Anti-Snoring",
  "deviceClass": "II",
  "regulationNumber": "872.5570",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 213,
    "last12Months": 18
  },
  "adverseEvents": {
    "total": 1153,
    "last12Months": 643
  },
  "reviewDays": {
    "median": 142,
    "sampleSize": 213
  },
  "recalls": {
    "total": 10,
    "recent": [
      {
        "resNumber": "Z-2769-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Prismatik Dentalcraft, Inc.",
        "firmAsPublished": "Prismatik Dentalcraft, Inc.",
        "reason": "Due to device not having FDA Clearance",
        "initiated": "2026-04-27"
      },
      {
        "resNumber": "Z-0956-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Myofunctional Research Company USA",
        "firmAsPublished": "Myofunctional Research Company USA",
        "reason": "Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.",
        "initiated": "2025-10-09"
      },
      {
        "resNumber": "Z-1494-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Dental Choice Holding Llc",
        "firmAsPublished": "Dental Choice Holding Llc",
        "reason": "The device was marketed and sold in the US without FDA clearance.",
        "initiated": "2022-05-23"
      },
      {
        "resNumber": "Z-1947-2018",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Respire Medical",
        "firmAsPublished": "Respire Medical",
        "reason": "Potential for device breakage during use",
        "initiated": "2017-09-01"
      },
      {
        "resNumber": "Z-1948-2018",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Respire Medical",
        "firmAsPublished": "Respire Medical",
        "reason": "Potential for device breakage during use",
        "initiated": "2017-09-01"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261366",
      "deviceName": "Virtus",
      "applicant": "Somnomed, Inc.",
      "company": "Somnomed, Inc.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2026-04-27"
    },
    {
      "kNumber": "K261251",
      "deviceName": "Snorbliss® Anti-Snoring Device",
      "applicant": "Endeavor Commerce, LLC",
      "company": "Endeavor Commerce, LLC",
      "decisionDate": "2026-06-11",
      "dateReceived": "2026-04-16"
    },
    {
      "kNumber": "K261134",
      "deviceName": "Dormiva Anti-Snoring Mouth Guard",
      "applicant": "Koncept Innovators, Inc.",
      "company": "Koncept Innovators, LLC",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-04-07"
    },
    {
      "kNumber": "K252942",
      "deviceName": "ShaeferH",
      "applicant": "Shaeferh, LLC",
      "company": "Shaeferh, LLC",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-09-15"
    },
    {
      "kNumber": "K253845",
      "deviceName": "Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)",
      "applicant": "Ram.Shaw Pte. , Ltd.",
      "company": "Ram.Shaw Pte. , Ltd.",
      "decisionDate": "2026-03-03",
      "dateReceived": "2025-12-02"
    },
    {
      "kNumber": "K252531",
      "deviceName": "Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)",
      "applicant": "Myofunctional Research Co.",
      "company": "Myofunctional Research Corp. Pty. , Ltd.",
      "decisionDate": "2026-03-02",
      "dateReceived": "2025-08-12"
    },
    {
      "kNumber": "K252976",
      "deviceName": "Park Dental Nylon MAD",
      "applicant": "Park Dental Research Corp.",
      "company": "Park Dental Research Corporation",
      "decisionDate": "2025-12-18",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K253868",
      "deviceName": "QuietLab Pro",
      "applicant": "QuietLab, LLC",
      "company": "QuietLab, LLC",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-12-03"
    },
    {
      "kNumber": "K252161",
      "deviceName": "Hushd Avera",
      "applicant": "Good Sleep CO Pte , Ltd.",
      "company": "Good Sleep CO Pte , Ltd.",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-07-10"
    },
    {
      "kNumber": "K252525",
      "deviceName": "AIO Breathe",
      "applicant": "Aiomega, LLC",
      "company": "Aiomega, LLC",
      "decisionDate": "2025-11-06",
      "dateReceived": "2025-08-11"
    }
  ],
  "topApplicants": [
    {
      "name": "Somnomed, Inc.",
      "count": 8
    },
    {
      "name": "Sleeping Well, LLC",
      "count": 6
    },
    {
      "name": "Airway Management, Inc.",
      "count": 4
    },
    {
      "name": "Allen J. Moses, Dds, Ltd.",
      "count": 4
    },
    {
      "name": "Oventus Manufacturing Pty, Ltd.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Somnomed, Inc.",
      "count": 9,
      "spellings": 2
    },
    {
      "name": "Sleeping Well, LLC",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Airway Management, Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Allen J. Moses, Dds, Ltd.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Always More Marketing, Inc.",
      "count": 4,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Endeavor Commerce, LLC",
      "since": "2026-06-11",
      "kNumber": "K261251"
    },
    {
      "name": "Shaeferh, LLC",
      "since": "2026-04-10",
      "kNumber": "K252942"
    },
    {
      "name": "Ram.Shaw Pte. , Ltd.",
      "since": "2026-03-03",
      "kNumber": "K253845"
    },
    {
      "name": "Myofunctional Research Corp. Pty. , Ltd.",
      "since": "2026-03-02",
      "kNumber": "K252531"
    },
    {
      "name": "Park Dental Research Corporation",
      "since": "2025-12-18",
      "kNumber": "K252976"
    },
    {
      "name": "QuietLab, LLC",
      "since": "2025-12-05",
      "kNumber": "K253868"
    },
    {
      "name": "Aiomega, LLC",
      "since": "2025-11-06",
      "kNumber": "K252525"
    },
    {
      "name": "Nightguard Express, LLC",
      "since": "2025-11-03",
      "kNumber": "K252698"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
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        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 3,
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        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
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        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 6,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 18,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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        "month": "2024-11-01",
        "observed": 21,
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        "isSufficient": false
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      {
        "month": "2024-12-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2025-01-01",
        "observed": 25,
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        "expectedHigh": 43.68012619328766,
        "isSufficient": true
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        "month": "2025-02-01",
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        "expectedHigh": 39.418990792962866,
        "isSufficient": true
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        "month": "2025-03-01",
        "observed": 32,
        "expectedLow": 0,
        "expectedHigh": 44.88755330684761,
        "isSufficient": true
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        "month": "2025-04-01",
        "observed": 34,
        "expectedLow": 0.9079484188663394,
        "expectedHigh": 49.49258952439182,
        "isSufficient": true
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        "month": "2025-05-01",
        "observed": 32,
        "expectedLow": 4.758277453958117,
        "expectedHigh": 47.529848694837966,
        "isSufficient": true
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        "month": "2025-06-01",
        "observed": 38,
        "expectedLow": 8.89390776746901,
        "expectedHigh": 49.31701306286609,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 93,
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        "expectedHigh": 83.9004638900152,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 52,
        "expectedLow": 16.319595729167155,
        "expectedHigh": 78.19065329831083,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 68,
        "expectedLow": 19.379396024079053,
        "expectedHigh": 83.27663306126001,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 84,
        "expectedLow": 21.47604896720069,
        "expectedHigh": 90.4353913318717,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 66,
        "expectedLow": 22.068092353068927,
        "expectedHigh": 94.01810656631746,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 110,
        "expectedLow": 27.03455661615204,
        "expectedHigh": 106.84536988612886,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 106,
        "expectedLow": 36.31914135258111,
        "expectedHigh": 148.23908779175457,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 90,
        "expectedLow": 33.82554174105575,
        "expectedHigh": 129.26906062793867,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 86,
        "expectedLow": 41.96585139537227,
        "expectedHigh": 142.66805713126357,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LRK (Device, Anti-Snoring) has four findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2769-2026, Z-0956-2026). 12 first-time filers in the last 12 months, including Endeavor Commerce, LLC and Shaeferh, LLC (K261251, K252942, K253845, K252531, K252976). Clearances are running 36% faster — a median 91 days over the last 12 months against 142 days all-time (elapsed calendar days, not FDA review days) (LRK:review_time:12m). The code is crowded, scoring 97 of 100 — 147 companies hold a clearance here and 18 arrived in the last 12 months (LRK:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2769-2026",
          "Z-0956-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "12 first-time filers in the last 12 months, including Endeavor Commerce, LLC and Shaeferh, LLC",
        "recordIds": [
          "K261251",
          "K252942",
          "K253845",
          "K252531",
          "K252976"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 36% faster — a median 91 days over the last 12 months against 142 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "LRK:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 147 companies hold a clearance here and 18 arrived in the last 12 months",
        "recordIds": [
          "LRK:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ALRK"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALRK"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALRK"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALRK"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALRK"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALRK"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALRK"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.740Z"
}