FIH
5 FDA 510(k) clearances · Product code
193 daysmedian time to decision
692 days90th percentile
5clearances measured
FDA profile
- Official device name
- Pump, Infusion Or Syringe, Extra-Luminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2001: 12 · 2002: 8 · 2003: 4 · 2004: 5 · 2005: 2 · 2006: 4
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 |
|---|---|---|
| PERCUPUMP II (K932055) | E-Z-Em, Inc. | 1995-03-21 |
| VECTOR AMBULATORY DRUG DELIVERY SYSTEM (K935461) | Infusion Technology Intl. | 1994-04-28 |
| CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (K931113) | Pharmacia Deltec, Inc. | 1994-04-28 |
| SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (K900439) | L H M Ent., Inc. | 1990-02-15 |
| INTROCULAR FLUID INJECTOR (K881707) | B&B Medical Assoc., Inc. | 1988-10-21 |
Track FIH automatically
Every clearance here is in the API, with alerts when new ones post.