GBA
5 FDA 510(k) clearances · Product code
78 daysmedian time to decision
141 days90th percentile
5clearances measured
FDA profile
- Official device name
- Catheter, Balloon Type
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2020: 13 · 2021: 20 · 2022: 27 · 2023: 22 · 2024: 16 · 2025: 23
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 |
|---|---|---|
| BYRON WORD BARTHOLIAN GLAND CATHETER (K861877) | Byron Medical | 1986-05-30 |
| BALLOON RETENTION CHEST CATHETER (K802025) | Loseff Medical Designers, Ltd. | 1980-09-26 |
| ELECATH MULTI-PURPOSE ARTERIAL SURGER (K790444) | Electro-Catheter Corp. | 1979-06-11 |
| CATHETER, TRANSLUMINAL BALLOON (K781772) | Medi-Tech, Inc. | 1979-03-06 |
| TUBE, LEATHERMAN/IMBRUCE (K781665) | National Catheter Co. Div. Mallinckrodt | 1978-12-15 |
Track GBA automatically
Every clearance here is in the API, with alerts when new ones post.