{ "code": "DRG", "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency", "deviceClass": "II", "regulationNumber": "870.2910", "panel": "Cardiovascular", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 192, "last12Months": 3 }, "adverseEvents": { "total": 113, "last12Months": 55 }, "reviewDays": { "median": 99, "sampleSize": 192 }, "recalls": { "total": 11, "recent": [ { "resNumber": "Z-2616-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Biointellisense Inc.", "firmAsPublished": "Biointellisense Inc.", "reason": "Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.", "initiated": "2024-07-19" }, { "resNumber": "Z-1162-2021", "status": "Open, Classified", "recallClass": "Class II", "firm": "Nihon Kohden America Inc", "firmAsPublished": "Nihon Kohden America Inc", "reason": "Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.", "initiated": "2021-01-08" }, { "resNumber": "Z-2537-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Vitalconnect Inc.", "firmAsPublished": "Vitalconnect Inc.", "reason": "A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.", "initiated": "2020-05-21" }, { "resNumber": "Z-3132-2017", "status": "Terminated", "recallClass": "Class II", "firm": "Boston Scientific Corporation", "firmAsPublished": "Boston Scientific Corporation", "reason": "The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.", "initiated": "2017-05-15" }, { "resNumber": "Z-1708-2017", "status": "Terminated", "recallClass": "Class II", "firm": "Philips Visicu", "firmAsPublished": "Philips Visicu", "reason": "eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team.\r\n\r\nA software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.", "initiated": "2017-03-02" } ] }, "recentClearances": [ { "kNumber": "K261569", "deviceName": "UbiqVue™ 2AYe Cardiac System (UX2253)", "applicant": "Lifesignals, Inc.", "company": "Lifesignals, Inc.", "decisionDate": "2026-07-09", "dateReceived": "2026-05-12" }, { "kNumber": "K252984", "deviceName": "Perin Health System (PHD80060-2)", "applicant": "Perin Health Devices, LLC", "company": "Perin Health Devices, LLC", "decisionDate": "2026-01-22", "dateReceived": "2025-09-18" }, { "kNumber": "K252440", "deviceName": "EasyTeleMed (2.0.2)", "applicant": "Ingeniars S.R.L.", "company": "Ingeniars S.R.L.", "decisionDate": "2025-10-02", "dateReceived": "2025-08-04" }, { "kNumber": "K250259", "deviceName": "TeleRehab Aermos Cardiopulmonary Rehabilitation", "applicant": "The ScottCare Corporation", "company": "The ScottCare Corporation", "decisionDate": "2025-06-04", "dateReceived": "2025-01-28" }, { "kNumber": "K243837", "deviceName": "iBSM", "applicant": "Iorbit Digital Technologies Private Limited", "company": "Iorbit Digital Technologies Private Limited", "decisionDate": "2025-05-16", "dateReceived": "2024-12-13" }, { "kNumber": "K242018", "deviceName": "UbiqVue™ 2A Multi-parameter System (UX2550)", "applicant": "Lifesignals, Inc.", "company": "Lifesignals, Inc.", "decisionDate": "2024-11-12", "dateReceived": "2024-07-10" }, { "kNumber": "K241101", "deviceName": "BioButton System", "applicant": "Biointellisense, Inc.", "company": "Biointellisense Inc.", "decisionDate": "2024-09-26", "dateReceived": "2024-04-22" }, { "kNumber": "K240251", "deviceName": "ANNE Chest", "applicant": "Sibel Health, Inc.", "company": "Sibel Health, Inc.", "decisionDate": "2024-06-03", "dateReceived": "2024-01-30" }, { "kNumber": "K223711", "deviceName": "ANNE One", "applicant": "Sibel Health, Inc.", "company": "Sibel Health, Inc.", "decisionDate": "2023-08-10", "dateReceived": "2022-12-12" }, { "kNumber": "K220526", "deviceName": "HD+12, HD+15", "applicant": "Cardioline S.P.A", "company": "Cardioline S.P.A.", "decisionDate": "2023-05-15", "dateReceived": "2022-02-24" } ], "topApplicants": [ { "name": "Vitalconnect, Inc.", "count": 9 }, { "name": "American Telecare, Inc.", "count": 5 }, { "name": "General Devices", "count": 5 }, { "name": "Honeywell Hommed, LLC", "count": 5 }, { "name": "Nihon Kohden America, Inc.", "count": 5 } ], "topCompanies": [ { "name": "Vitalconnect Inc.", "count": 9, "spellings": 1 }, { "name": "Honeywell Hommed, LLC", "count": 6, "spellings": 2 }, { "name": "American Telecare, Inc.", "count": 5, "spellings": 1 }, { "name": "General Devices", "count": 5, "spellings": 1 }, { "name": "Nihon Kohden America Inc", "count": 5, "spellings": 1 } ], "newEntrants": [ { "name": "Perin Health Devices, LLC", "since": "2026-01-22", "kNumber": "K252984" }, { "name": "Ingeniars S.R.L.", "since": "2025-10-02", "kNumber": "K252440" } ], "baseline": { "months": [ { "month": "2023-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-03-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-07-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 11, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 6, "expectedLow": 0, "expectedHigh": 12.35250966420631, "isSufficient": true }, { "month": "2026-03-01", "observed": 9, "expectedLow": 0.04605198298073061, "expectedHigh": 13.169176683261052, "isSufficient": true } ], "sufficientMonths": 2, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency) has two findings, most consequential first. 2 first-time filers in the last 12 months, Perin Health Devices, LLC and Ingeniars S.R.L (K252984, K252440). The code is crowded, scoring 76 of 100 — 124 companies hold a clearance here and 3 arrived in the last 12 months (DRG:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Perin Health Devices, LLC and Ingeniars S.R.L.", "recordIds": [ "K252984", "K252440" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 76 of 100 — 124 companies hold a clearance here and 3 arrived in the last 12 months", "recordIds": [ "DRG: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%3ADRG" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRG" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADRG" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADRG" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADRG" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADRG" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADRG" } ], "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": "2026-08-11T13:51:45.679Z" }