FDA product code EOQ: Bronchoscope (Flexible Or Rigid)
EOQ is the FDA product code for bronchoscope (flexible or rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 243 510(k) submissions under EOQ, 64 in the last five years, from 103 different applicants. The average 510(k) review took 125 days (median 95); 164 days on average over the last three years. FDA has posted 160 recalls for EOQ devices, 85 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Bronchoscope (Flexible Or Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for EOQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 145 |
| 2018 | 7 | 204 |
| 2019 | 11 | 160 |
| 2020 | 10 | 132 |
| 2021 | 15 | 158 |
| 2022 | 11 | 162 |
| 2023 | 12 | 149 |
| 2024 | 13 | 160 |
| 2025 | 20 | 140 |
| 2026 | 8 | 192 |
Compare with all 510(k) review times · Search every EOQ clearance
Top EOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corp. | 12 | 2026-04-23 |
| KARL STORZ Endoscopy-America, Inc. | 12 | 2007-08-24 |
| Ambu A/S | 11 | 2026-09-16 |
| Mill-Rose Laboratory | 11 | 1998-10-30 |
| Intuitive Surgical, Inc. | 10 | 2025-09-23 |
98 more applicants have EOQ clearances. See the full list in Caduvo.
Most recent EOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260309 | Ambu A/S | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | 2026-09-16 | 229 |
| K254026 | Flexicare Medical Limited. | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | 2026-09-02 | 260 |
| K260382 | Auris Health, Inc. | MONARCH Platform (MON-000008) | 2026-07-25 | 170 |
| K254037 | Free Flow Medical, Inc. | LungFlow Airway Catheter | 2026-07-10 | 206 |
| K253137 | Fujifilm Corporation | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | 2026-06-16 | 264 |
Recalls for EOQ devices
160 product recalls in 46 recall events; 85 initiated in the last five years and 86 still open. Most recent: 2026-01-29.
| Year | Recalls |
|---|---|
| 2018 | 30 |
| 2019 | 3 |
| 2020 | 10 |
| 2021 | 20 |
| 2022 | 6 |
| 2023 | 42 |
| 2024 | 7 |
| 2025 | 27 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code EOQ?
EOQ is the FDA product code for bronchoscope (flexible or rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is EOQ?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code EOQ?
Across 243 cleared submissions the average was 125 days from receipt to decision (median 95).
Which companies have the most EOQ clearances?
Olympus Medical Systems Corp. (12); KARL STORZ Endoscopy-America, Inc. (12); Ambu A/S (11); Mill-Rose Laboratory (11); Intuitive Surgical, Inc. (10).
Have EOQ devices been recalled?
Yes: 160 product recalls across 46 recall events; the most recent began 2026-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code EOQ
- Run a recall and safety report across every EOQ manufacturer
- Watch product code EOQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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