{ "code": "EOQ", "deviceName": "Bronchoscope (Flexible Or Rigid)", "deviceClass": "II", "regulationNumber": "874.4680", "panel": "Ear, Nose, Throat", "definition": "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 241, "last12Months": 13 }, "adverseEvents": { "total": 18726, "last12Months": 5883 }, "reviewDays": { "median": 94, "sampleSize": 241 }, "recalls": { "total": 160, "recent": [ { "resNumber": "Z-1488-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Olympus Corporation of the Americas", "firmAsPublished": "Olympus Corporation of the Americas", "reason": "Potential for rubber fragment detachment during use.", "initiated": "2026-01-29" }, { "resNumber": "Z-1489-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Olympus Corporation of the Americas", "firmAsPublished": "Olympus Corporation of the Americas", "reason": "Potential for rubber fragment detachment during use.", "initiated": "2026-01-29" }, { "resNumber": "Z-1383-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Auris Health, Inc", "firmAsPublished": "Auris Health, Inc", "reason": "Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.", "initiated": "2026-01-21" }, { "resNumber": "Z-1134-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Intuitive Surgical, Inc.", "firmAsPublished": "Intuitive Surgical, Inc.", "reason": "Due to probe bags that may have a compromised or incomplete sterile pouch seal.", "initiated": "2025-12-04" }, { "resNumber": "Z-0598-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Noah Medical Corporation", "firmAsPublished": "Noah Medical Corporation", "reason": "Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.", "initiated": "2025-09-12" } ] }, "recentClearances": [ { "kNumber": "K260382", "deviceName": "MONARCH™ Platform (MON-000008)", "applicant": "Auris Health, Inc.", "company": "Auris Health, Inc", "decisionDate": "2026-07-25", "dateReceived": "2026-02-05" }, { "kNumber": "K254037", "deviceName": "LungFlow Airway Catheter", "applicant": "Free Flow Medical, Inc.", "company": "Free Flow Medical, Inc.", "decisionDate": "2026-07-10", "dateReceived": "2025-12-16" }, { "kNumber": "K253137", "deviceName": "FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T", "applicant": "Fujifilm Corporation", "company": "Fujifilm Corporation", "decisionDate": "2026-06-16", "dateReceived": "2025-09-25" }, { "kNumber": "K260565", "deviceName": "SmartClip Delivery Catheter (ADR-1715)", "applicant": "Elucent Medical", "company": "Elucent Medical Inc", "decisionDate": "2026-05-14", "dateReceived": "2026-02-19" }, { "kNumber": "K252341", "deviceName": "EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)", "applicant": "Olympus Medical Systems Corp.", "company": "Olympus Medical Systems Corporation", "decisionDate": "2026-04-23", "dateReceived": "2025-07-28" }, { "kNumber": "K260420", "deviceName": "LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)", "applicant": "MacroLux Medical Technology Co., Ltd.", "company": "MacroLux Medical Technology Co., Ltd.", "decisionDate": "2026-04-08", "dateReceived": "2026-02-09" }, { "kNumber": "K250863", "deviceName": "FUJIFILM Ultrasonic Endoscope EB-710US", "applicant": "Fujifilm Corporation", "company": "Fujifilm Corporation", "decisionDate": "2025-12-12", "dateReceived": "2025-03-21" }, { "kNumber": "K251731", "deviceName": "KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)", "applicant": "Karl Storz SE & CO. KG", "company": "KARL STORZ SE & CO. KG", "decisionDate": "2025-12-05", "dateReceived": "2025-06-06" }, { "kNumber": "K252045", "deviceName": "Ion Endoluminal System (IF1000)", "applicant": "Intuitive Surgical, Inc.", "company": "Intuitive Surgical, Inc.", "decisionDate": "2025-09-23", "dateReceived": "2025-06-30" }, { "kNumber": "K251894", "deviceName": "Himaging Bronchscope System", "applicant": "Himaging Technology (Shanghai) Co., Ltd.", "company": "Himaging Technology (Shanghai) Co., Ltd.", "decisionDate": "2025-09-23", "dateReceived": "2025-06-20" } ], "topApplicants": [ { "name": "KARL STORZ Endoscopy-America, Inc.", "count": 12 }, { "name": "Olympus Medical Systems Corp.", "count": 12 }, { "name": "Mill-Rose Laboratory", "count": 11 }, { "name": "Ambu A/S", "count": 10 }, { "name": "Intuitive Surgical, Inc.", "count": 10 } ], "topCompanies": [ { "name": "Olympus Medical Systems Corporation", "count": 19, "spellings": 2 }, { "name": "Karl Storz Endoscopy America Inc", "count": 13, "spellings": 2 }, { "name": "Intuitive Surgical, Inc.", "count": 11, "spellings": 2 }, { "name": "Mill-Rose Laboratory", "count": 11, "spellings": 1 }, { "name": "Ambu A/S", "count": 10, "spellings": 1 } ], "newEntrants": [ { "name": "Free Flow Medical, Inc.", "since": "2026-07-10", "kNumber": "K254037" }, { "name": "Elucent Medical Inc", "since": "2026-05-14", "kNumber": "K260565" }, { "name": "KARL STORZ SE & CO. KG", "since": "2025-12-05", "kNumber": "K251731" }, { "name": "Himaging Technology (Shanghai) Co., Ltd.", "since": "2025-09-23", "kNumber": "K251894" }, { "name": "Zhejiang UE Medical Corp.", "since": "2025-08-11", "kNumber": "K251823" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 362, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 342, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 410, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 366, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 437, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 398, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 363, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 447, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 422, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 507, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 438, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 521, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 443, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 507, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 478, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 504, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 501, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 492, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 532, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 861, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 267, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 254, "expectedLow": 217.5197063676484, "expectedHigh": 711.9090879195169, "isSufficient": true }, { "month": "2025-02-01", "observed": 352, "expectedLow": 106.72300964367382, "expectedHigh": 591.2652760001332, "isSufficient": true }, { "month": "2025-03-01", "observed": 322, "expectedLow": 120.39117917258687, "expectedHigh": 665.2502054225147, "isSufficient": true }, { "month": "2025-04-01", "observed": 436, "expectedLow": 97.01100319676976, "expectedHigh": 668.9499046981574, "isSufficient": true }, { "month": "2025-05-01", "observed": 415, "expectedLow": 106.32904155182139, "expectedHigh": 642.4801963751445, "isSufficient": true }, { "month": "2025-06-01", "observed": 473, "expectedLow": 124.25954029677742, "expectedHigh": 678.0459302763813, "isSufficient": true }, { "month": "2025-07-01", "observed": 650, "expectedLow": 230.4998878504852, "expectedHigh": 1096.1837178068604, "isSufficient": true }, { "month": "2025-08-01", "observed": 648, "expectedLow": 171.2507662014499, "expectedHigh": 825.4255759465548, "isSufficient": true }, { "month": "2025-09-01", "observed": 653, "expectedLow": 216.140688691646, "expectedHigh": 927.5849440485916, "isSufficient": true }, { "month": "2025-10-01", "observed": 700, "expectedLow": 232.89890570122716, "expectedHigh": 951.7816593297293, "isSufficient": true }, { "month": "2025-11-01", "observed": 625, "expectedLow": 233.84216452079698, "expectedHigh": 902.2788400841183, "isSufficient": true }, { "month": "2025-12-01", "observed": 936, "expectedLow": 357.11094110052255, "expectedHigh": 920.9825310535488, "isSufficient": true }, { "month": "2026-01-01", "observed": 812, "expectedLow": 465.5298386528441, "expectedHigh": 1215.3184170849388, "isSufficient": true }, { "month": "2026-02-01", "observed": 692, "expectedLow": 432.94959910292323, "expectedHigh": 979.4208469529491, "isSufficient": true }, { "month": "2026-03-01", "observed": 1009, "expectedLow": 476.7483647683346, "expectedHigh": 1059.653387473778, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "EOQ (Bronchoscope (Flexible Or Rigid)) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1488-2026, Z-1489-2026, Z-1383-2026, Z-1134-2026, Z-0598-2026). 5 first-time filers in the last 12 months, including Free Flow Medical, Inc. and Elucent Medical Inc (K254037, K260565, K251731, K251894, K251823). The code is crowded, scoring 89 of 100 — 96 companies hold a clearance here and 13 arrived in the last 12 months (EOQ:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1488-2026", "Z-1489-2026", "Z-1383-2026", "Z-1134-2026", "Z-0598-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "5 first-time filers in the last 12 months, including Free Flow Medical, Inc. and Elucent Medical Inc", "recordIds": [ "K254037", "K260565", "K251731", "K251894", "K251823" ], "severity": 45 }, { "kind": "crowding", "detail": "the code is crowded, scoring 89 of 100 — 96 companies hold a clearance here and 13 arrived in the last 12 months", "recordIds": [ "EOQ: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%3AEOQ" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEOQ" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEOQ" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEOQ" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEOQ" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEOQ" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEOQ" } ], "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": "2026-08-11T13:51:45.695Z" }