{ "code": "JOW", "deviceName": "Sleeve, Limb, Compressible", "deviceClass": "II", "regulationNumber": "870.5800", "panel": "Cardiovascular", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 351, "last12Months": 8 }, "adverseEvents": { "total": 110, "last12Months": 23 }, "reviewDays": { "median": 126, "sampleSize": 351 }, "recalls": { "total": 32, "recent": [ { "resNumber": "Z-1917-2025", "status": "Completed", "recallClass": "Class II", "firm": "Cardinal Health 200, LLC", "firmAsPublished": "Cardinal Health 200, LLC", "reason": "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.", "initiated": "2025-05-13" }, { "resNumber": "Z-1918-2025", "status": "Completed", "recallClass": "Class II", "firm": "Cardinal Health 200, LLC", "firmAsPublished": "Cardinal Health 200, LLC", "reason": "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.", "initiated": "2025-05-13" }, { "resNumber": "Z-1919-2025", "status": "Completed", "recallClass": "Class II", "firm": "Cardinal Health 200, LLC", "firmAsPublished": "Cardinal Health 200, LLC", "reason": "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.", "initiated": "2025-05-13" }, { "resNumber": "Z-1612-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "Stryker Sustainability Solutions", "firmAsPublished": "Stryker Sustainability Solutions", "reason": "Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.", "initiated": "2023-04-14" }, { "resNumber": "Z-2324-2021", "status": "Open, Classified", "recallClass": "Class II", "firm": "Ortho8, Inc.", "firmAsPublished": "Ortho8, Inc.", "reason": "CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance", "initiated": "2021-07-09" } ] }, "recentClearances": [ { "kNumber": "K253386", "deviceName": "DVT Garment", "applicant": "Vistar Medical Supplies Co., Ltd.", "company": "Vistar Medical Supplies Co., Ltd.", "decisionDate": "2026-06-25", "dateReceived": "2025-09-30" }, { "kNumber": "K250242", "deviceName": "Compression Therapy Device (LGT-2202DVT)", "applicant": "Guangzhou Longest Medical Technology Co., Ltd.", "company": "Guangzhou Longest Medical Technology Co., Ltd.", "decisionDate": "2026-04-24", "dateReceived": "2025-01-27" }, { "kNumber": "K254267", "deviceName": "NanoPress 760A-BT (760A-BT)", "applicant": "Mego Afek , Ltd.", "company": "Mego Afek , Ltd.", "decisionDate": "2026-02-24", "dateReceived": "2025-12-30" }, { "kNumber": "K250974", "deviceName": "Bio Arterial Deluxe (IC-BAP-DX)", "applicant": "Bio Compression Systems, Inc.", "company": "Bio Compression Systems, Inc.", "decisionDate": "2025-12-12", "dateReceived": "2025-03-31" }, { "kNumber": "K250190", "deviceName": "Sequential Compression System (SCD600)", "applicant": "Shenzhen Comen Medical Instruments Co.,Ltd", "company": "SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.", "decisionDate": "2025-12-08", "dateReceived": "2025-01-23" }, { "kNumber": "K251466", "deviceName": "VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr", "applicant": "Wellell, Inc.", "company": "Wellell, Inc.", "decisionDate": "2025-10-28", "dateReceived": "2025-05-13" }, { "kNumber": "K251446", "deviceName": "PlasmaFlow X Compression Sleeve Device (XPF0001)", "applicant": "Manamed, LLC", "company": "Manamed, Inc.", "decisionDate": "2025-09-17", "dateReceived": "2025-05-09" }, { "kNumber": "K251086", "deviceName": "PnueAira (PNCU-01)", "applicant": "Biotab, LLC", "company": "Biotab, LLC", "decisionDate": "2025-08-18", "dateReceived": "2025-04-09" }, { "kNumber": "K250817", "deviceName": "Coretech Compression System (Coretech RHB3003)", "applicant": "Vive Health, LLC", "company": "Vive Health, LLC", "decisionDate": "2025-08-08", "dateReceived": "2025-03-18" }, { "kNumber": "K241096", "deviceName": "Venera 608 Deep Vein Thrombosis (DVT) Prevention System", "applicant": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.", "company": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.", "decisionDate": "2025-01-15", "dateReceived": "2024-04-22" } ], "topApplicants": [ { "name": "Bio Compression Systems, Inc.", "count": 11 }, { "name": "Mego Afek AC , Ltd.", "count": 11 }, { "name": "Hygia Health Services, Inc.", "count": 9 }, { "name": "Medical Compression Systems (Dbn) , Ltd.", "count": 9 }, { "name": "Aircast, Inc.", "count": 7 } ], "topCompanies": [ { "name": "Bio Compression Systems, Inc.", "count": 11, "spellings": 1 }, { "name": "Mego Afek AC , Ltd.", "count": 11, "spellings": 1 }, { "name": "Hygia Health Services, Inc.", "count": 9, "spellings": 1 }, { "name": "Medical Compression Systems (Dbn) , Ltd.", "count": 9, "spellings": 1 }, { "name": "Alliance Medical Corp.", "count": 8, "spellings": 2 } ], "newEntrants": [ { "name": "Vistar Medical Supplies Co., Ltd.", "since": "2026-06-25", "kNumber": "K253386" }, { "name": "Guangzhou Longest Medical Technology Co., Ltd.", "since": "2026-04-24", "kNumber": "K250242" }, { "name": "SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.", "since": "2025-12-08", "kNumber": "K250190" }, { "name": "Wellell, Inc.", "since": "2025-10-28", "kNumber": "K251466" }, { "name": "Biotab, LLC", "since": "2025-08-18", "kNumber": "K251086" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "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": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-07-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "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": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "JOW (Sleeve, Limb, Compressible) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Vistar Medical Supplies Co., Ltd. and Guangzhou Longest Medical Technology Co., Ltd (K253386, K250242, K250190, K251466, K251086). The code is crowded, scoring 92 of 100 — 158 companies hold a clearance here and 8 arrived in the last 12 months (JOW:crowding).", "severity": 45, "factors": [ { "kind": "new_entrant", "detail": "5 first-time filers in the last 12 months, including Vistar Medical Supplies Co., Ltd. and Guangzhou Longest Medical Technology Co., Ltd.", "recordIds": [ "K253386", "K250242", "K250190", "K251466", "K251086" ], "severity": 45 }, { "kind": "crowding", "detail": "the code is crowded, scoring 92 of 100 — 158 companies hold a clearance here and 8 arrived in the last 12 months", "recordIds": [ "JOW: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%3AJOW" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJOW" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJOW" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJOW" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJOW" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJOW" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJOW" } ], "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": "2026-08-11T13:51:45.725Z" }