FJF
5 FDA 510(k) clearances · Product code
71 daysmedian time to decision
148 days90th percentile
5clearances measured
FDA profile
- Official device name
- Detector, Air Bubble
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1994: 1
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 |
|---|---|---|
| MINNILERT AIR DETECTOR (K904992) | Minntech Corp. | 1991-02-05 |
| NICKLE-TITANIUM ORTHODONTIC WIRE (K891327) | American Orthodontics | 1989-05-10 |
| BLOOD LEVEL DETECTOR-MODEL 7601 (K781330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| DETECTOR, BUBBLE & FOAM (K780582) | Hospal Medical Corp. | 1978-06-22 |
| DIALYSIS MACHINE, CENTRY II (K770857) | Cobe Laboratories, Inc. | 1977-10-04 |
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Every clearance here is in the API, with alerts when new ones post.