FDA product code · Gastroenterology, Urology · Class 2
OCX: Endoscopic Irrigation/Suction System
OCX is FDA's product code for "Endoscopic Irrigation/Suction System": a Class 2 device classified under 21 CFR 876.1500, reviewed by the Gastroenterology, Urology panel.
510(k) review time for OCX
Across 41 510(k) clearances under OCX decided from 2018-01-01 to 2026-10-06, the median was 107 days from FDA receipt to decision. Half took between 60 and 194 days, and 80% were decided within 221 days. These are past clearances, not a forecast for a new submission.
| Fastest | 22 |
|---|---|
| 25th percentile | 60 |
| Median | 107 |
| 75th percentile | 194 |
| 80th percentile | 221 |
| 90th percentile | 269 |
| Slowest | 406 |
| Year | Median days | n |
|---|---|---|
| 2018 | 60 | 5 |
| 2019 | 133 | 8 |
| 2022 | 84 | 6 |
| 2023 | 109 | 7 |
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.
OCX in the public FDA record
| 510(k) clearances, all years | 93 |
|---|---|
| Device recalls | 18 |
| Establishment listings | 225 |
| GUDID device identifiers | 474 |
Counts of records, not of devices or events. Adverse event reports for OCX 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 OCX
1 FDA recognized consensus standard cite OCX, among them ISO 10079-4 First edition 2021-08. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-158 ISO 10079-4 First edition 2021-08 — Medical suction equipment - Part 4: General requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.