{ "code": "CAC", "deviceName": "Apparatus, Autotransfusion", "deviceClass": "II", "regulationNumber": "868.5830", "panel": "Anesthesiology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 195, "last12Months": 0 }, "adverseEvents": { "total": 309, "last12Months": 75 }, "reviewDays": { "median": 101, "sampleSize": 195 }, "recalls": { "total": 89, "recent": [ { "resNumber": "Z-0709-2024", "status": "Open, Classified", "recallClass": "Class I", "firm": "Maquet Cardiovascular, LLC", "firmAsPublished": "Maquet Cardiovascular, LLC", "reason": "Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.", "initiated": "2023-12-13" }, { "resNumber": "Z-0710-2024", "status": "Open, Classified", "recallClass": "Class I", "firm": "Maquet Cardiovascular, LLC", "firmAsPublished": "Maquet Cardiovascular, LLC", "reason": "Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.", "initiated": "2023-12-13" }, { "resNumber": "Z-0621-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Atrium Medical Corporation", "firmAsPublished": "Atrium Medical Corporation", "reason": "A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.", "initiated": "2023-11-01" }, { "resNumber": "Z-0316-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Atrium Medical Corporation", "firmAsPublished": "Atrium Medical Corporation", "reason": "Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of\ncatheter(s) and patient tube connections with single collection chamber chest drains", "initiated": "2023-09-18" }, { "resNumber": "Z-0317-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Atrium Medical Corporation", "firmAsPublished": "Atrium Medical Corporation", "reason": "Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of\ncatheter(s) and patient tube connections with single collection chamber chest drains", "initiated": "2023-09-18" } ] }, "recentClearances": [ { "kNumber": "K241236", "deviceName": "XTRA Collection sets; XTRA Sequestration set X", "applicant": "Sorin Group Italia S.R.L.", "company": "Sorin Group Italia S.r.l.", "decisionDate": "2024-08-16", "dateReceived": "2024-05-02" }, { "kNumber": "K240426", "deviceName": "Aventus Clot Management System", "applicant": "Inquis Medical", "company": "INQUIS MEDICAL, INC.", "decisionDate": "2024-05-14", "dateReceived": "2024-02-13" }, { "kNumber": "K240584", "deviceName": "XTRA Autotransfusion System (with XTRA Bowl sets)", "applicant": "Sorin Group Italia S.R.L.", "company": "Sorin Group Italia S.r.l.", "decisionDate": "2024-04-29", "dateReceived": "2024-03-01" }, { "kNumber": "K231782", "deviceName": "FlowSaver Blood Return System (80-101)", "applicant": "Inari Medical, Inc.", "company": "Inari Medical, Inc.", "decisionDate": "2023-07-14", "dateReceived": "2023-06-16" }, { "kNumber": "K221483", "deviceName": "FlowSaver Blood Return System", "applicant": "Inari Medical, Inc.", "company": "Inari Medical, Inc.", "decisionDate": "2023-02-17", "dateReceived": "2022-05-23" }, { "kNumber": "K221722", "deviceName": "Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)", "applicant": "Haemonetics Corporation", "company": "Haemonetics Corporation", "decisionDate": "2022-11-15", "dateReceived": "2022-06-14" }, { "kNumber": "K201305", "deviceName": "Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain", "applicant": "Atrium Medical Corporation", "company": "Atrium Medical Corporation", "decisionDate": "2021-09-03", "dateReceived": "2020-05-15" }, { "kNumber": "K210862", "deviceName": "Hemafuse System", "applicant": "Sisu Global Health", "company": "Sisu Global Health", "decisionDate": "2021-07-29", "dateReceived": "2021-03-23" }, { "kNumber": "K210176", "deviceName": "FlowSaver Blood Filter", "applicant": "Inari Medical", "company": "Inari Medical, Inc.", "decisionDate": "2021-07-22", "dateReceived": "2021-01-22" }, { "kNumber": "K210089", "deviceName": "CATSmart, Automated Blood Processing Autotransfusion System", "applicant": "Fresenius Kabi AG", "company": "Fresenius Kabi, LLC", "decisionDate": "2021-02-11", "dateReceived": "2021-01-13" } ], "topApplicants": [ { "name": "Haemonetics Corp.", "count": 15 }, { "name": "Boehringer Laboratories", "count": 12 }, { "name": "Deknatel, Inc.", "count": 11 }, { "name": "Shiley, Inc.", "count": 11 }, { "name": "Atrium Medical Corp.", "count": 9 } ], "topCompanies": [ { "name": "Haemonetics Corporation", "count": 18, "spellings": 2 }, { "name": "Boehringer Laboratories, Inc.", "count": 12, "spellings": 1 }, { "name": "Deknatel, Inc.", "count": 11, "spellings": 1 }, { "name": "Shiley, Inc.", "count": 11, "spellings": 1 }, { "name": "Atrium Medical Corporation", "count": 10, "spellings": 2 } ], "newEntrants": [], "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": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 16, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 40, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 15, "expectedLow": 0, "expectedHigh": 32.45497924349553, "isSufficient": true }, { "month": "2025-02-01", "observed": 9, "expectedLow": 0, "expectedHigh": 28.167644423800464, "isSufficient": true }, { "month": "2025-03-01", "observed": 11, "expectedLow": 0, "expectedHigh": 30.07493171360798, "isSufficient": true }, { "month": "2025-04-01", "observed": 10, "expectedLow": 0, "expectedHigh": 29.8213228489052, "isSufficient": true }, { "month": "2025-05-01", "observed": 9, "expectedLow": 0, "expectedHigh": 27.03465550227951, "isSufficient": true }, { "month": "2025-06-01", "observed": 7, "expectedLow": 0, "expectedHigh": 27.271746383004185, "isSufficient": true }, { "month": "2025-07-01", "observed": 9, "expectedLow": 0, "expectedHigh": 41.15001726074421, "isSufficient": true }, { "month": "2025-08-01", "observed": 21, "expectedLow": 0, "expectedHigh": 30.102477982643013, "isSufficient": true }, { "month": "2025-09-01", "observed": 11, "expectedLow": 0, "expectedHigh": 35.498872047354936, "isSufficient": true }, { "month": "2025-10-01", "observed": 8, "expectedLow": 0, "expectedHigh": 34.36691278352266, "isSufficient": true }, { "month": "2025-11-01", "observed": 5, "expectedLow": 0, "expectedHigh": 30.316570021348923, "isSufficient": true }, { "month": "2025-12-01", "observed": 8, "expectedLow": 0, "expectedHigh": 19.943947184225287, "isSufficient": true }, { "month": "2026-01-01", "observed": 10, "expectedLow": 0, "expectedHigh": 21.608726764873047, "isSufficient": true }, { "month": "2026-02-01", "observed": 9, "expectedLow": 0.37077086466531756, "expectedHigh": 17.167114404144467, "isSufficient": true }, { "month": "2026-03-01", "observed": 10, "expectedLow": 0.5449369050958958, "expectedHigh": 18.86821660059967, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "CAC (Apparatus, Autotransfusion): nothing changed in the six FDA sources we watch.", "severity": 1, "factors": [], "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%3ACAC" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAC" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAC" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACAC" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACAC" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACAC" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACAC" } ], "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": "2026-08-11T13:51:45.668Z" }