FDA product code ODC: Endoscope Channel Accessory
ODC is the FDA product code for endoscope channel accessory. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 72 510(k) submissions under ODC, 30 in the last five years, from 50 different applicants. The average 510(k) review took 130 days (median 110); 176 days on average over the last three years. FDA has posted 3 recalls for ODC devices, 3 initiated in the last five years.
Definition
To give the endoscope channel additional or improved functionality.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope Channel Accessory |
| 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 ODC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 269 |
| 2018 | 2 | 101 |
| 2019 | 4 | 68 |
| 2020 | 4 | 164 |
| 2021 | 6 | 162 |
| 2022 | 8 | 115 |
| 2023 | 7 | 181 |
| 2024 | 8 | 125 |
| 2025 | 6 | 134 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every ODC clearance
Top ODC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 6 | 2024-11-08 |
| Ga Health Company Limited | 4 | 2023-10-16 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 3 | 2025-06-20 |
| Medivators (A Subsidiary of Steris Corporation) | 3 | 2024-03-22 |
| United States Endoscopy Group, Inc. | 3 | 2019-09-17 |
45 more applicants have ODC clearances. See the full list in Caduvo.
Most recent ODC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252933 | Dyne Medical Group, Inc. | DYNE PORT | 2026-06-12 | 270 |
| K250145 | Endosound, Inc. | Biopsy Port Adapter | 2025-10-17 | 269 |
| K252910 | Boston Scientific | Orca Air/Water and Suction Valves | 2025-10-09 | 27 |
| K250949 | Olympus Medical Systems Corporation | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | 2025-07-16 | 110 |
| K250732 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Disposable Endoscopy Valve Set | 2025-06-20 | 101 |
Recalls for ODC devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-05-12.
| Year | Recalls |
|---|---|
| 2026 | 3 |
Frequently asked questions
What is FDA product code ODC?
ODC is the FDA product code for endoscope channel accessory. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODC?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODC?
Across 72 cleared submissions the average was 130 days from receipt to decision (median 110).
Which companies have the most ODC clearances?
STERIS Corporation (6); Ga Health Company Limited (4); Yangzhou Fartley Medical Instrument Technology Co., Ltd. (3); Medivators (A Subsidiary of Steris Corporation) (3); United States Endoscopy Group, Inc. (3).
Have ODC devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2026-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ODC
- Run a recall and safety report across every ODC manufacturer
- Watch product code ODC 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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