EYC
5 FDA 510(k) clearances · Product code
182 daysmedian time to decision
311 days90th percentile
5clearances measured
FDA profile
- Official device name
- Catheter, Upper Urinary Tract
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2024: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Foley Catheter with Temperature Sensor (K200757) | Deroyal Industries, Inc. | 2020-10-15 |
| FOLEY CATHETERS WITH TEMPERATURE PROBE (K061918) | GE Healthcare | 2006-08-18 |
| EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (K041416) | Deroyal | 2004-07-02 |
| EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S (K925790) | Deroyal Industries, Inc. | 1993-05-17 |
| STERILE FOLEY CATHETER (K890310) | Kosan Far East Ent. , Ltd. | 1989-11-30 |
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Every clearance here is in the API, with alerts when new ones post.