Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HKP — Predicate Candidate Screening

16 FDA 510(k) clearances under this product code; the 50 most recent screened below.

70 daysmedian FDA review time

165 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K952558	AARON VAC 2	Aaron Medical Industries	1997-03-19	656
K950056	THE GRIESHABER AXIAL CUTTER	Grieshaber & Co.	1995-05-05	119
K950287	UNIVIT PROBE	Medical Instrument Development Laboratories, Inc.	1995-04-10	76
K896622	VISITEC VITRECTOMY UNIT	Visitec Co.	1990-04-04	134
K890595	MENTOR ANTERIOR SEGMENT VITRECTOR	Mentor O & O, Inc.	1989-04-17	70
K832074	CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA	CooperVision, Inc.	1983-08-01	34
K822599	KEATES I/A SYSTEM FRIGITRONICS 4000	Frigitronics of Connecticut, Inc.	1982-10-06	40
K813273	EMERGENCY POWER PAC (EMPAC)	Optical Micro Systems, Inc.	1981-12-31	41
K810152	X-VEE	Temporaty Surgical Systems	1981-03-17	55
K801231	EYE-VAC	Coburn Optical Ind., Inc.	1980-07-21	55
K791898	OCUTOME MODEL 8000	Cooper Medical Devices Corp.	1979-10-30	35
K791000	VITREOUS SUCTION/CUTTER	Concept, Inc.	1979-09-04	98
K790893	STAT	Varian Assoc., Inc.	1979-08-28	112
K780852	CLINITEX VIS-X ASPIRATING ACCESSORY	Varian Assoc., Inc.	1978-11-03	165
K761353	VITEROUS SUCTION CUTTER	Concept, Inc.	1977-01-05	8
K760684	VISC X-VITREOUS ASPIRATING & CUT. INSTR	Varian Assoc., Inc.	1976-10-05	15

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda