FDA product code · Gastroenterology, Urology · Class 2
GBM: Catheter, Urethral
GBM is FDA's product code for "Catheter, Urethral": a Class 2 device classified under 21 CFR 876.5130, reviewed by the Gastroenterology, Urology panel.
510(k) review time for GBM
Across 22 510(k) clearances under GBM decided from 2018-01-01 to 2026-10-06, the median was 190 days from FDA receipt to decision. Half took between 88 and 254 days, and 80% were decided within 262 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 88 |
| Median | 190 |
| 75th percentile | 254 |
| 80th percentile | 262 |
| 90th percentile | 268 |
| Slowest | 384 |
| Year | Median days | n |
|---|---|---|
| 2018 | 93 | 6 |
| 2019 | 121 | 7 |
| 2020 | 230 | 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.
GBM in the public FDA record
| 510(k) clearances, all years | 71 |
|---|---|
| Device recalls | 18 |
| Establishment listings | 162 |
| GUDID device identifiers | 725 |
Counts of records, not of devices or events. Adverse event reports for GBM 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 GBM
1 FDA recognized consensus standard cite GBM, among them ASTM F623-19. 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.