FDA product code FEB: Accessories, Cleaning, For Endoscope
FEB is the FDA product code for accessories, cleaning, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel. FDA has cleared 57 510(k) submissions under FEB, 4 in the last five years, from 33 different applicants. The average 510(k) review took 209 days (median 111); 132 days on average over the last three years. FDA has posted 40 recalls for FEB devices, 28 initiated in the last five years.
Definition
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 | Accessories, Cleaning, For Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | HO — General Hospital |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 188 |
| 2018 | 1 | 155 |
| 2019 | 2 | 206 |
| 2020 | 2 | 456 |
| 2022 | 1 | 36 |
| 2023 | 1 | 88 |
| 2024 | 2 | 132 |
Compare with all 510(k) review times · Search every FEB clearance
Top FEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medivators, Inc. | 4 | 2022-01-14 |
| Advanced Sterilization Products | 4 | 2014-12-22 |
| Keymed, Inc. | 4 | 1993-03-29 |
| STERIS Corporation | 3 | 2024-12-02 |
| Olympus Medical Systems Corp. | 3 | 2020-09-01 |
28 more applicants have FEB clearances. See the full list in Caduvo.
Most recent FEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241168 | Wassenburg Medical, Inc. | System 83 Revolve Endoscope Washer/Disinfector | 2024-12-19 | 237 |
| K243433 | STERIS Corporation | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | 2024-12-02 | 27 |
| K230930 | STERIS Corporation | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | 2023-06-30 | 88 |
| K213833 | Medivators, Inc. | SCOPE BUDDY PLUS Endoscope Flushing Aid | 2022-01-14 | 36 |
| K201920 | Olympus Medical Systems Corp. | Endoscope Reprocessor OER-Elite | 2020-09-01 | 53 |
Recalls for FEB devices
40 product recalls in 19 recall events; 28 initiated in the last five years and 27 still open. Most recent: 2026-03-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 14 |
Frequently asked questions
What is FDA product code FEB?
FEB is the FDA product code for accessories, cleaning, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel.
What device class is FEB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEB?
Across 57 cleared submissions the average was 209 days from receipt to decision (median 111).
Which companies have the most FEB clearances?
Medivators, Inc. (4); Advanced Sterilization Products (4); Keymed, Inc. (4); STERIS Corporation (3); Olympus Medical Systems Corp. (3).
Have FEB devices been recalled?
Yes: 40 product recalls across 19 recall events; the most recent began 2026-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FEB
- Run a recall and safety report across every FEB manufacturer
- Watch product code FEB 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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