{ "code": "BTR", "deviceName": "Tube, Tracheal (W/Wo Connector)", "deviceClass": "II", "regulationNumber": "868.5730", "panel": "Anesthesiology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 241, "last12Months": 4 }, "adverseEvents": { "total": 4919, "last12Months": 1203 }, "reviewDays": { "median": 87, "sampleSize": 241 }, "recalls": { "total": 226, "recent": [ { "resNumber": "Z-1289-2025", "status": "Open, Classified", "recallClass": "Class I", "firm": "Smiths Medical ASD, Inc.", "firmAsPublished": "Smiths Medical ASD, Inc.", "reason": "Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.", "initiated": "2025-02-13" }, { "resNumber": "Z-1876-2024", "status": "Open, Classified", "recallClass": "Class I", "firm": "MEDLINE INDUSTRIES, LP - Northfield", "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield", "reason": "Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.", "initiated": "2024-02-26" }, { "resNumber": "Z-1827-2023", "status": "Open, Classified", "recallClass": "Class I", "firm": "Teleflex, Inc.", "firmAsPublished": "TELEFLEX LLC", "reason": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.", "initiated": "2023-05-25" }, { "resNumber": "Z-1828-2023", "status": "Open, Classified", "recallClass": "Class I", "firm": "Teleflex, Inc.", "firmAsPublished": "TELEFLEX LLC", "reason": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.", "initiated": "2023-05-25" }, { "resNumber": "Z-1829-2023", "status": "Open, Classified", "recallClass": "Class I", "firm": "Teleflex, Inc.", "firmAsPublished": "TELEFLEX LLC", "reason": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.", "initiated": "2023-05-25" } ] }, "recentClearances": [ { "kNumber": "K253437", "deviceName": "Spiro-VISTA", "applicant": "Spiro Robotics", "company": "Spiro Robotics", "decisionDate": "2026-06-12", "dateReceived": "2025-10-01" }, { "kNumber": "K250173", "deviceName": "Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)", "applicant": "Covidien, LLC", "company": "Covidien", "decisionDate": "2025-10-06", "dateReceived": "2025-01-21" }, { "kNumber": "K243785", "deviceName": "Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced", "applicant": "Covidien, LLC", "company": "Covidien", "decisionDate": "2025-09-25", "dateReceived": "2024-12-09" }, { "kNumber": "K243579", "deviceName": "AeroJet Ventilation Catheter", "applicant": "Pipeline Medical Products, LLC", "company": "Pipeline Medical Products, LLC", "decisionDate": "2025-08-13", "dateReceived": "2024-11-19" }, { "kNumber": "K251499", "deviceName": "Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)", "applicant": "William Cook Europe Aps", "company": "William Cook Europe Aps", "decisionDate": "2025-06-11", "dateReceived": "2025-05-15" }, { "kNumber": "K250243", "deviceName": "ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)", "applicant": "Flexicare Medical Limited.", "company": "Flexicare Medical Ltd.", "decisionDate": "2025-05-20", "dateReceived": "2025-01-27" }, { "kNumber": "K242495", "deviceName": "LMA Fastrach ETT SU", "applicant": "Teleflex Medical", "company": "Teleflex Medical", "decisionDate": "2025-04-29", "dateReceived": "2024-08-22" }, { "kNumber": "K241451", "deviceName": "Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)", "applicant": "Teleflex Incorporated", "company": "Teleflex, Inc.", "decisionDate": "2025-02-11", "dateReceived": "2024-05-22" }, { "kNumber": "K233341", "deviceName": "Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)", "applicant": "Covidien, LLC", "company": "Covidien", "decisionDate": "2024-05-20", "dateReceived": "2023-09-29" }, { "kNumber": "K223130", "deviceName": "Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)", "applicant": "Covidien", "company": "Covidien", "decisionDate": "2023-08-30", "dateReceived": "2022-10-03" } ], "topApplicants": [ { "name": "Sheridan Catheter Corp.", "count": 11 }, { "name": "Mallinckrodt Critical Care", "count": 10 }, { "name": "Rusch, Inc.", "count": 10 }, { "name": "Bivona Medical Technologies", "count": 8 }, { "name": "Polamedco, Inc.", "count": 7 } ], "topCompanies": [ { "name": "Sheridan Catheter Corp.", "count": 11, "spellings": 1 }, { "name": "Mallinckrodt Critical Care", "count": 10, "spellings": 1 }, { "name": "Rusch, Inc.", "count": 10, "spellings": 1 }, { "name": "Bivona Medical Technologies", "count": 8, "spellings": 1 }, { "name": "Polamedco, Inc.", "count": 7, "spellings": 1 } ], "newEntrants": [ { "name": "Spiro Robotics", "since": "2026-06-12", "kNumber": "K253437" }, { "name": "Pipeline Medical Products, LLC", "since": "2025-08-13", "kNumber": "K243579" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 108, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 93, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 130, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 115, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 100, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 146, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 91, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 83, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 104, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 141, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 105, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 125, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 153, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 172, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 131, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 143, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 169, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 182, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 113, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 122, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 122, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 119, "expectedLow": 74.52307783021033, "expectedHigh": 169.3371500599547, "isSufficient": true }, { "month": "2025-02-01", "observed": 107, "expectedLow": 63.310797412500165, "expectedHigh": 146.76373231492448, "isSufficient": true }, { "month": "2025-03-01", "observed": 127, "expectedLow": 74.50889671572283, "expectedHigh": 162.5009563773563, "isSufficient": true }, { "month": "2025-04-01", "observed": 167, "expectedLow": 80.16989278651056, "expectedHigh": 170.88046843700988, "isSufficient": true }, { "month": "2025-05-01", "observed": 181, "expectedLow": 84.94060035253044, "expectedHigh": 173.9826618405723, "isSufficient": true }, { "month": "2025-06-01", "observed": 147, "expectedLow": 95.03979867290927, "expectedHigh": 204.81185897042448, "isSufficient": true }, { "month": "2025-07-01", "observed": 138, "expectedLow": 146.87838043272802, "expectedHigh": 321.304477414026, "isSufficient": true }, { "month": "2025-08-01", "observed": 149, "expectedLow": 82.51347618789546, "expectedHigh": 228.53496227833867, "isSufficient": true }, { "month": "2025-09-01", "observed": 148, "expectedLow": 86.01935613369807, "expectedHigh": 237.82834359147753, "isSufficient": true }, { "month": "2025-10-01", "observed": 137, "expectedLow": 85.42006049477754, "expectedHigh": 225.6008273722004, "isSufficient": true }, { "month": "2025-11-01", "observed": 147, "expectedLow": 74.77361452025443, "expectedHigh": 195.9821754458405, "isSufficient": true }, { "month": "2025-12-01", "observed": 189, "expectedLow": 87.82474780240204, "expectedHigh": 219.81413061555233, "isSufficient": true }, { "month": "2026-01-01", "observed": 209, "expectedLow": 114.05058883262942, "expectedHigh": 265.6471724098299, "isSufficient": true }, { "month": "2026-02-01", "observed": 130, "expectedLow": 101.942069873475, "expectedHigh": 229.09956228823825, "isSufficient": true }, { "month": "2026-03-01", "observed": 137, "expectedLow": 97.82959573478176, "expectedHigh": 241.99612095775498, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "BTR (Tube, Tracheal (W/Wo Connector)) has two findings, most consequential first. 2 first-time filers in the last 12 months, Spiro Robotics and Pipeline Medical Products, LLC (K253437, K243579). The code is crowded, scoring 77 of 100 — 119 companies hold a clearance here and 4 arrived in the last 12 months (BTR:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Spiro Robotics and Pipeline Medical Products, LLC", "recordIds": [ "K253437", "K243579" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 77 of 100 — 119 companies hold a clearance here and 4 arrived in the last 12 months", "recordIds": [ "BTR: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%3ABTR" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTR" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABTR" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABTR" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABTR" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABTR" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABTR" } ], "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": "2026-08-11T13:51:45.664Z" }