FDA product code · Gastroenterology, Urology · Class 2
ODC: Endoscope Channel Accessory
ODC is FDA's product code for "Endoscope Channel Accessory": a Class 2 device classified under 21 CFR 876.1500, reviewed by the Gastroenterology, Urology panel.
510(k) review time for ODC
Across 46 510(k) clearances under ODC decided from 2018-01-01 to 2026-10-06, the median was 125 days from FDA receipt to decision. Half took between 49 and 206 days, and 80% were decided within 225 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 49 |
| Median | 125 |
| 75th percentile | 206 |
| 80th percentile | 225 |
| 90th percentile | 270 |
| Slowest | 461 |
| Year | Median days | n |
|---|---|---|
| 2021 | 181 | 6 |
| 2022 | 118 | 8 |
| 2023 | 126 | 7 |
| 2024 | 95 | 8 |
| 2025 | 106 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ODC in the public FDA record
| 510(k) clearances, all years | 72 |
|---|---|
| Establishment listings | 153 |
Counts of records, not of devices or events. Adverse event reports for ODC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ODC
No FDA recognized consensus standard cites ODC by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.