{ "code": "NUC", "deviceName": "Lubricant, Personal", "deviceClass": "II", "regulationNumber": "884.5300", "panel": "Obstetrics/Gynecology", "definition": "This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 246, "last12Months": 13 }, "adverseEvents": { "total": 37, "last12Months": 7 }, "reviewDays": { "median": 163, "sampleSize": 246 }, "recalls": { "total": 7, "recent": [ { "resNumber": "Z-1547-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "Family Dollar Stores, Llc.", "firmAsPublished": "Family Dollar Stores, Llc.", "reason": "Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.", "initiated": "2022-06-23" }, { "resNumber": "Z-0873-2013", "status": "Terminated", "recallClass": "Class II", "firm": "Mc-NEIL-PPC, Inc.", "firmAsPublished": "Mc-NEIL-PPC, Inc.", "reason": "This product is not cleared for marketing in the US.", "initiated": "2013-01-25" }, { "resNumber": "Z-0874-2013", "status": "Terminated", "recallClass": "Class II", "firm": "Mc-NEIL-PPC, Inc.", "firmAsPublished": "Mc-NEIL-PPC, Inc.", "reason": "This product is not cleared for marketing in the US.", "initiated": "2013-01-25" }, { "resNumber": "Z-0875-2013", "status": "Terminated", "recallClass": "Class II", "firm": "Mc-NEIL-PPC, Inc.", "firmAsPublished": "Mc-NEIL-PPC, Inc.", "reason": "This product is not cleared for marketing in the US.", "initiated": "2013-01-25" }, { "resNumber": "Z-2467-2012", "status": "Terminated", "recallClass": "Class II", "firm": "Mc-NEIL-PPC, Inc.", "firmAsPublished": "Mc-NEIL-PPC, Inc.", "reason": "Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi", "initiated": "2012-07-02" } ] }, "recentClearances": [ { "kNumber": "K261177", "deviceName": "PINKSLIP Water-Based Personal Lubricant and Moisturizer", "applicant": "PINKSLIP, LLC", "company": "PINKSLIP, LLC", "decisionDate": "2026-07-09", "dateReceived": "2026-04-10" }, { "kNumber": "K261909", "deviceName": "Plum Vagiceuticals™ Vaginal Moisturizing Suppositories", "applicant": "PCCA, Inc.", "company": "Pcca, Inc.", "decisionDate": "2026-07-06", "dateReceived": "2026-06-08" }, { "kNumber": "K254011", "deviceName": "Flow Water-Based Personal Lubricant", "applicant": "LBDO Group, Inc.", "company": "LBDO Group, Inc.", "decisionDate": "2026-06-22", "dateReceived": "2025-12-15" }, { "kNumber": "K261292", "deviceName": "PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)", "applicant": "PR Personal Care Laboratories", "company": "PR Personal Care Laboratories", "decisionDate": "2026-06-11", "dateReceived": "2026-04-20" }, { "kNumber": "K252914", "deviceName": "Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)", "applicant": "Hathor Professional Skincare , Ltd.", "company": "Hathor Professional Skincare , Ltd.", "decisionDate": "2026-06-09", "dateReceived": "2025-09-12" }, { "kNumber": "K260068", "deviceName": "pjur NATURE Touch, 100 ml", "applicant": "Pjur Group Luxembourg S.A.", "company": "pjur group Luxembourg S.A.", "decisionDate": "2026-05-21", "dateReceived": "2026-01-09" }, { "kNumber": "K254101", "deviceName": "Julva Velvé Water-Based Personal Lubricant", "applicant": "Golden Isles Medical, Inc.", "company": "Golden Isles Medical, Inc.", "decisionDate": "2026-04-16", "dateReceived": "2025-12-19" }, { "kNumber": "K260007", "deviceName": "Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)", "applicant": "Hudi Pharma Srl", "company": "Hudi Pharma Srl", "decisionDate": "2026-04-01", "dateReceived": "2026-01-02" }, { "kNumber": "K253983", "deviceName": "Water-based lubricant", "applicant": "Guangzhou Haoyimai Trading Co., Ltd.", "company": "Guangzhou Haoyimai Trading Co., Ltd.", "decisionDate": "2026-03-06", "dateReceived": "2025-12-12" }, { "kNumber": "K251011", "deviceName": "Chiavaye Personal Moisturizer", "applicant": "Unipack, LLC", "company": "Unipack, LLC", "decisionDate": "2025-12-19", "dateReceived": "2025-04-01" } ], "topApplicants": [ { "name": "Biofilm, Inc.", "count": 13 }, { "name": "United Consortium", "count": 13 }, { "name": "CC Wellness, LLC", "count": 10 }, { "name": "Church & Dwight Co., Inc.", "count": 8 }, { "name": "Rb Health (Us), LLC", "count": 8 } ], "topCompanies": [ { "name": "United Consortium, Inc.", "count": 14, "spellings": 2 }, { "name": "Biofilm, Inc.", "count": 13, "spellings": 1 }, { "name": "CC Wellness, LLC", "count": 10, "spellings": 1 }, { "name": "Rb Health (Us), LLC", "count": 9, "spellings": 2 }, { "name": "Church & Dwight Inc", "count": 8, "spellings": 1 } ], "newEntrants": [ { "name": "PINKSLIP, LLC", "since": "2026-07-09", "kNumber": "K261177" }, { "name": "Pcca, Inc.", "since": "2026-07-06", "kNumber": "K261909" }, { "name": "LBDO Group, Inc.", "since": "2026-06-22", "kNumber": "K254011" }, { "name": "PR Personal Care Laboratories", "since": "2026-06-11", "kNumber": "K261292" }, { "name": "Golden Isles Medical, Inc.", "since": "2026-04-16", "kNumber": "K254101" }, { "name": "Hudi Pharma Srl", "since": "2026-04-01", "kNumber": "K260007" }, { "name": "Guangzhou Haoyimai Trading Co., Ltd.", "since": "2026-03-06", "kNumber": "K253983" }, { "name": "Unipack, LLC", "since": "2025-12-19", "kNumber": "K251011" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "NUC (Lubricant, Personal) has three findings, most consequential first. 10 first-time filers in the last 12 months, including PINKSLIP, LLC and Pcca, Inc (K261177, K261909, K254011, K261292, K254101). Clearances are running 44% faster — a median 91 days over the last 12 months against 163 days all-time (elapsed calendar days, not FDA review days) (NUC:review_time:12m). The code is crowded, scoring 94 of 100 — 126 companies hold a clearance here and 13 arrived in the last 12 months (NUC:crowding).", "severity": 50, "factors": [ { "kind": "new_entrant", "detail": "10 first-time filers in the last 12 months, including PINKSLIP, LLC and Pcca, Inc.", "recordIds": [ "K261177", "K261909", "K254011", "K261292", "K254101" ], "severity": 50 }, { "kind": "review_time_shift", "detail": "clearances are running 44% faster — a median 91 days over the last 12 months against 163 days all-time (elapsed calendar days, not FDA review days)", "recordIds": [ "NUC:review_time:12m" ], "severity": 30 }, { "kind": "crowding", "detail": "the code is crowded, scoring 94 of 100 — 126 companies hold a clearance here and 13 arrived in the last 12 months", "recordIds": [ "NUC: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%3ANUC" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANUC" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANUC" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ANUC" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ANUC" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ANUC" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ANUC" } ], "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": "2026-08-11T13:51:45.749Z" }