{ "code": "FRC", "deviceName": "Indicator, Biological Sterilization Process", "deviceClass": "II", "regulationNumber": "880.2800", "panel": "General Hospital", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 206, "last12Months": 2 }, "adverseEvents": { "total": 40, "last12Months": 6 }, "reviewDays": { "median": 115, "sampleSize": 206 }, "recalls": { "total": 40, "recent": [ { "resNumber": "Z-2331-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "HF Acquisition Co. LLC", "firmAsPublished": "HF Acquisition Co LLC", "reason": "Due to incorrect incubation process being performed on product.", "initiated": "2026-04-13" }, { "resNumber": "Z-2332-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "HF Acquisition Co. LLC", "firmAsPublished": "HF Acquisition Co LLC", "reason": "Due to incorrect incubation process being performed on product.", "initiated": "2026-04-13" }, { "resNumber": "Z-1248-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "TERRAGENE S.A.", "firmAsPublished": "TERRAGENE S.A.", "reason": "Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.", "initiated": "2025-01-15" }, { "resNumber": "Z-1141-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "HF Acquisition Co. LLC", "firmAsPublished": "HF Acquisition Co LLC", "reason": "Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.", "initiated": "2024-12-11" }, { "resNumber": "Z-0837-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "TERRAGENE S.A.", "firmAsPublished": "TERRAGENE S.A.", "reason": "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.", "initiated": "2023-12-07" } ] }, "recentClearances": [ { "kNumber": "K260766", "deviceName": "Celerity 5 HP Biological Indicator (LCB052)", "applicant": "STERIS Corporation", "company": "Steris Corporation", "decisionDate": "2026-04-08", "dateReceived": "2026-03-09" }, { "kNumber": "K252680", "deviceName": "Celerity™ 20 HP Biological Indicator", "applicant": "STERIS Corporation", "company": "Steris Corporation", "decisionDate": "2025-09-24", "dateReceived": "2025-08-25" }, { "kNumber": "K251122", "deviceName": "Terragene® Bionova® BT20 Biological Indicator", "applicant": "Terragene", "company": "TERRAGENE SA", "decisionDate": "2025-08-04", "dateReceived": "2025-04-11" }, { "kNumber": "K251452", "deviceName": "Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)", "applicant": "Steris", "company": "Steris Corporation", "decisionDate": "2025-06-06", "dateReceived": "2025-05-09" }, { "kNumber": "K250061", "deviceName": "Celerity Incubator", "applicant": "STERIS Corporation", "company": "Steris Corporation", "decisionDate": "2025-02-06", "dateReceived": "2025-01-10" }, { "kNumber": "K250044", "deviceName": "Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)", "applicant": "STERIS Corporation", "company": "Steris Corporation", "decisionDate": "2025-02-06", "dateReceived": "2025-01-10" }, { "kNumber": "K243501", "deviceName": "3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M", "applicant": "3M Company", "company": "3M Company", "decisionDate": "2025-01-28", "dateReceived": "2024-11-12" }, { "kNumber": "K242453", "deviceName": "Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)", "applicant": "Terragene S.A.", "company": "TERRAGENE S.A.", "decisionDate": "2024-12-12", "dateReceived": "2024-08-19" }, { "kNumber": "K242538", "deviceName": "3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M", "applicant": "3M Company", "company": "3M Company", "decisionDate": "2024-11-25", "dateReceived": "2024-08-26" }, { "kNumber": "K241959", "deviceName": "3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)", "applicant": "3M Company", "company": "3M Company", "decisionDate": "2024-10-18", "dateReceived": "2024-07-03" } ], "topApplicants": [ { "name": "STERIS Corporation", "count": 33 }, { "name": "3M Company", "count": 31 }, { "name": "Advanced Sterilization Products", "count": 17 }, { "name": "Raven Biological Laboratories, Inc.", "count": 12 }, { "name": "Spsmedical Supply Corp.", "count": 9 } ], "topCompanies": [ { "name": "Steris Corporation", "count": 35, "spellings": 2 }, { "name": "3M Company", "count": 32, "spellings": 2 }, { "name": "Advanced Sterilization Products", "count": 17, "spellings": 1 }, { "name": "Raven Biological Laboratories, Inc.", "count": 12, "spellings": 1 }, { "name": "Spsmedical Supply Corp. A Division of Cantel Medical", "count": 10, "spellings": 2 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 16, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 2, "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": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "FRC (Indicator, Biological Sterilization Process) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2331-2026, Z-2332-2026).", "severity": 75, "factors": [ { "kind": "recall", "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2331-2026", "Z-2332-2026" ], "severity": 75 } ], "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%3AFRC" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRC" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRC" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFRC" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFRC" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFRC" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFRC" } ], "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": "2026-08-11T13:51:45.697Z" }