Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

HPS — Predicate Candidate Screening

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

86 daysmedian FDA review time

192 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K202038	CryoTreQ	VitreQ BV	2020-12-30	160	1
K940373	OPHTHALMIC CRYO UNIT	Dutch Ophthalmic USA, Inc.	1994-07-18	173	0
K923629	OPHTHALMIC TRICHIASIS PROBE	Mira, Inc.	1992-10-19	90	0
K903303	SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES	Spembly Medical , Ltd.	1990-10-11	79	0
K874555	KEELER ACU 22XT OPHTHALMIC CRYO UNIT	Keeler Instruments, Inc.	1988-01-29	86	0
K873388	KEELER CTU CRYO SYSTEM	Keeler Instruments, Inc.	1987-11-13	81	0
K870195	UNITED SURGICAL CORP. CRYOPTIC PLUS	United Surgical Corp.	1987-02-20	31	0
K833747	GALLIE CRYONUCLEATOR	Mono Research Laboratories	1984-05-09	196	0
K801418	KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT	Keeler Optical Products , Ltd.	1980-07-21	34	0
K781338	BEAVER CATARACT CYROXTRACTOR	Edward Weck, Inc.	1979-02-12	192	0
K790102	MODEL 556-01 CRYOEXTRACTOR	Intermedics, Inc.	1979-02-12	27	0

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