FDA product code · Gastroenterology, Urology · Class 2
KOD: Catheter, Urological
KOD is FDA's product code for "Catheter, Urological": a Class 2 device classified under 21 CFR 876.5130, reviewed by the Gastroenterology, Urology panel.
510(k) review time for KOD
Across 11 510(k) clearances under KOD decided from 2018-01-01 to 2026-10-06, the median was 251 days from FDA receipt to decision. Half took between 220 and 263 days, and 80% were decided within 264 days. These are past clearances, not a forecast for a new submission.
| Fastest | 41 |
|---|---|
| 25th percentile | 220 |
| Median | 251 |
| 75th percentile | 263 |
| 80th percentile | 264 |
| 90th percentile | 303 |
| Slowest | 345 |
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.
KOD in the public FDA record
| 510(k) clearances, all years | 238 |
|---|---|
| Device recalls | 108 |
| Establishment listings | 311 |
| GUDID device identifiers | 1,843 |
Counts of records, not of devices or events. Adverse event reports for KOD 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 KOD
2 FDA recognized consensus standards cite KOD, 1 of them recognized only in part, among them ASTM F623-19; ISO 20696 First edition 2018-06; Corrected 2019-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 9-132 ASTM F623-19 — Standard Performance Specification for Foley Catheter
- 9-143 ISO 20696 First edition 2018-06; Corrected 2019-12 (partial recognition) — Sterile urethral catheters for single use
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.