HKP
16 FDA 510(k) clearances · Product code
70 daysmedian time to decision
165 days90th percentile
16clearances measured
FDA profile
- Official device name
- Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 2 · 1998: 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 |
|---|---|---|
| AARON VAC 2 (K952558) | Aaron Medical Industries | 1997-03-19 |
| THE GRIESHABER AXIAL CUTTER (K950056) | Grieshaber & Co. | 1995-05-05 |
| UNIVIT PROBE (K950287) | Medical Instrument Development Laboratories, Inc. | 1995-04-10 |
| VISITEC VITRECTOMY UNIT (K896622) | Visitec Co. | 1990-04-04 |
| MENTOR ANTERIOR SEGMENT VITRECTOR (K890595) | Mentor O & O, Inc. | 1989-04-17 |
| CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K832074) | CooperVision, Inc. | 1983-08-01 |
| KEATES I/A SYSTEM FRIGITRONICS 4000 (K822599) | Frigitronics of Connecticut, Inc. | 1982-10-06 |
| EMERGENCY POWER PAC (EMPAC) (K813273) | Optical Micro Systems, Inc. | 1981-12-31 |
| X-VEE (K810152) | Temporaty Surgical Systems | 1981-03-17 |
| EYE-VAC (K801231) | Coburn Optical Ind., Inc. | 1980-07-21 |
| OCUTOME MODEL 8000 (K791898) | Cooper Medical Devices Corp. | 1979-10-30 |
| VITREOUS SUCTION/CUTTER (K791000) | Concept, Inc. | 1979-09-04 |
| STAT (K790893) | Varian Assoc., Inc. | 1979-08-28 |
| CLINITEX VIS-X ASPIRATING ACCESSORY (K780852) | Varian Assoc., Inc. | 1978-11-03 |
| VITEROUS SUCTION CUTTER (K761353) | Concept, Inc. | 1977-01-05 |
| VISC X-VITREOUS ASPIRATING & CUT. INSTR (K760684) | Varian Assoc., Inc. | 1976-10-05 |
Track HKP automatically
Every clearance here is in the API, with alerts when new ones post.