FIR
7 FDA 510(k) clearances · Product code
34 daysmedian time to decision
85 days90th percentile
7clearances measured
FDA profile
- Official device name
- Pump, Blood, Extra-Luminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2001: 1 · 2002: 1 · 2007: 2 · 2008: 2
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 |
|---|---|---|
| ATI PLASMA PUMP (PP-04) (K961137) | Apheresis Technologies, Inc. | 1996-06-14 |
| INFUSION PUMP (K831953) | Cryosan, Inc. | 1983-07-19 |
| ASAHI BLOOD/PLASMA PUMP #ABP-01A & (K830818) | Parker Hannifin Corp. | 1983-04-12 |
| SPS-SINGLE PATIENT SYSTEM (K821139) | Extracorporeal Medical Specialities, Inc. | 1982-05-10 |
| BLOOD PUMP-MODE S10K (K780410) | 3M Health Care, Sarns | 1978-05-03 |
| RS-7800 MINIPUMP (K771705) | Renal Systems, Inc. | 1977-10-04 |
| HEPARIN PUMP (K761050) | Dws, Inc. | 1976-12-30 |
Track FIR automatically
Every clearance here is in the API, with alerts when new ones post.