FDA product code FEQ: Pump, Air, Non-Manual, For Endoscope
FEQ is the FDA product code for pump, air, non-manual, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 21 510(k) submissions under FEQ, 1 in the last five years, from 8 different applicants. The average 510(k) review took 79 days (median 50). FDA has posted 5 recalls for FEQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Air, Non-Manual, For Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FEQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 2 | 34 |
| 2019 | 1 | 49 |
| 2022 | 1 | 28 |
Compare with all 510(k) review times · Search every FEQ clearance
Top FEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Endoscopy Group, Inc. | 6 | 2019-08-01 |
| Endochoice, Inc. | 6 | 2016-06-27 |
| Erbe USA, Inc. | 3 | 2016-08-31 |
| Keymed (Medical & Industrial Equipment), Ltd. | 2 | 2010-09-13 |
| STERIS Corporation | 1 | 2022-03-11 |
3 more applicants have FEQ clearances. See the full list in Caduvo.
Most recent FEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220395 | STERIS Corporation | EndoGator Endoscopy Irrigation Tubing | 2022-03-11 | 28 |
| K191559 | United States Endoscopy Group, Inc. | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | 2019-08-01 | 49 |
| K182258 | United States Endoscopy Group, Inc. | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | 2018-09-21 | 31 |
| K173650 | United States Endoscopy Group, Inc. | AquaShield System CO2- Fujifilm | 2018-01-05 | 38 |
| K163424 | United State Endoscopy Group, Inc. | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON | 2017-01-04 | 29 |
Recalls for FEQ devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-03-31.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FEQ?
FEQ is the FDA product code for pump, air, non-manual, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FEQ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEQ?
Across 21 cleared submissions the average was 79 days from receipt to decision (median 50).
Which companies have the most FEQ clearances?
United States Endoscopy Group, Inc. (6); Endochoice, Inc. (6); Erbe USA, Inc. (3); Keymed (Medical & Industrial Equipment), Ltd. (2); STERIS Corporation (1).
Have FEQ devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code FEQ
- Run a recall and safety report across every FEQ manufacturer
- Watch product code FEQ 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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