FDA product code · Ear, Nose, Throat
EOQBronchoscope (Flexible Or Rigid)
Product code EOQ covers Bronchoscope (Flexible Or Rigid), a Class II device regulated under 21 CFR 874.4680. FDA has cleared 241 devices in this code, 13 of them in the last 12 months. Median review time across the 241 most recent decisions is 94 days. openFDA lists 160 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 874.4680
- Review panel
- Ear, Nose, Throat
- Clearances
- 241
What is happening in EOQ right now?
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).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1488-2026, Z-1489-2026, Z-1383-2026, Z-1134-2026, Z-0598-2026 |
| New entrant | Worth knowing | K254037, K260565, K251731, K251894, K251823 |
| Crowding | Context | EOQ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code EOQ cover?
EOQ is FDA's product code for Bronchoscope (Flexible Or Rigid), a Class II device regulated under 21 CFR 874.4680.
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).
Source: openFDA device/classification · record EOQ · retrieved
How many devices has FDA cleared in EOQ?
FDA has cleared 241 devices under product code EOQ since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260382 | MONARCH Platform (MON-000008) | Auris Health, Inc. | |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. | |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. |
How long does FDA review take for EOQ?
The median FDA review time for EOQ is 94 days, measured across the 241 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EOQ?
openFDA lists 160 recall records against product code EOQ. A recall record covers one firm's corrective action and may span many device lots.
Z-1488-2026Open, ClassifiedOlympus Corporation of the Americas
Potential for rubber fragment detachment during use.
Z-1489-2026Open, ClassifiedOlympus Corporation of the Americas
Potential for rubber fragment detachment during use.
Z-1383-2026Open, ClassifiedAuris Health, Inc
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.
Z-1134-2026Open, ClassifiedIntuitive Surgical, Inc.
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Z-0598-2026Open, ClassifiedNoah Medical Corporation
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Showing the 5 most recently initiated of 160. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EOQ?
MAUDE holds 18,726 adverse-event reports naming product code EOQ, 5,883 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EOQ unusual?
One month sits above EOQ's own expected range: 1 December 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 362 | Insufficient history | No expected range — too little history | |
| 342 | Insufficient history | No expected range — too little history | |
| 410 | Insufficient history | No expected range — too little history | |
| 366 | Insufficient history | No expected range — too little history | |
| 437 | Insufficient history | No expected range — too little history | |
| 398 | Insufficient history | No expected range — too little history | |
| 363 | Insufficient history | No expected range — too little history | |
| 447 | Insufficient history | No expected range — too little history | |
| 422 | Insufficient history | No expected range — too little history | |
| 507 | Insufficient history | No expected range — too little history | |
| 438 | Insufficient history | No expected range — too little history | |
| 521 | Insufficient history | No expected range — too little history | |
| 443 | Insufficient history | No expected range — too little history | |
| 507 | Insufficient history | No expected range — too little history | |
| 478 | Insufficient history | No expected range — too little history | |
| 504 | Insufficient history | No expected range — too little history | |
| 501 | Insufficient history | No expected range — too little history | |
| 492 | Insufficient history | No expected range — too little history | |
| 532 | Insufficient history | No expected range — too little history | |
| 861 | Insufficient history | No expected range — too little history | |
| 267 | Insufficient history | No expected range — too little history | |
| 254 | 218–712 | Within expected (218–712) | |
| 352 | 107–591 | Within expected (107–591) | |
| 322 | 120–665 | Within expected (120–665) | |
| 436 | 97–669 | Within expected (97–669) | |
| 415 | 106–642 | Within expected (106–642) | |
| 473 | 124–678 | Within expected (124–678) | |
| 650 | 230–1,096 | Within expected (230–1,096) | |
| 648 | 171–825 | Within expected (171–825) | |
| 653 | 216–928 | Within expected (216–928) | |
| 700 | 233–952 | Within expected (233–952) | |
| 625 | 234–902 | Within expected (234–902) | |
| 936 | 357–921 | Above expected (357–921) | |
| 812 | 466–1,215 | Within expected (466–1,215) | |
| 692 | 433–979 | Within expected (433–979) | |
| 1,009 | 477–1,060 | Within expected (477–1,060) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in EOQ.
Who has entered EOQ in the last year?
5 companies filed in EOQ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Free Flow Medical, Inc. | K254037 | |
| Elucent Medical Inc | K260565 | |
| KARL STORZ SE & CO. KG | K251731 | |
| Himaging Technology (Shanghai) Co., Ltd. | K251894 | |
| Zhejiang UE Medical Corp. | K251823 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in EOQ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EOQ?
Across the 241 most recent decisions, these applicants filed most often in EOQ.
| Applicant | Recent clearances |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | 12 |
| Olympus Medical Systems Corp. | 12 |
| Mill-Rose Laboratory | 11 |
| Ambu A/S | 10 |
| Intuitive Surgical, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in EOQ file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Olympus Medical Systems Corporation | 19 | 2 |
| Karl Storz Endoscopy America Inc | 13 | 2 |
| Intuitive Surgical, Inc. | 11 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch EOQ
Get an email the morning anything changes in EOQ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.