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

HMP — Predicate Candidate Screening

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

55 daysmedian FDA review time

91 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K940333	EYE PAD	Certified Safety Mfg., Inc.	1994-03-07	41
K921349	STERILE,DISPOSABLE EYE DRESSING	Deroyal Industries, Inc.	1992-05-29	71
K904896	EYE PAD	Ulti-Med Intl., Inc.	1990-12-05	36
K883822	FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309	Consolidated Industries of Greater Syracuse, Inc.	1988-11-22	76
K874411	DONALDSON NATURAL EYEPATCH 'PATIENT PAK'	Keeler Instruments, Inc.	1988-01-27	91
K864810	LIDSPLINT	Precision Therapeutics, Inc.	1987-01-20	42
K861456	SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR	Pantheon Products, Inc.	1986-07-25	98
K860979	DONALDSON NATURAL EYEPATCH	Keeler Instruments, Inc.	1986-04-04	21
K851906	SURGICAL EYE PACK	Xanmed Corp.	1985-05-21	20
K850099	VISOPROTECT: OCCULAR SHIELD	Rockway Enterprises, Inc.	1985-03-20	68
K850005	VISOPROTECT OCCULAR SHIELD	M.S.G. Health Systems, Inc.	1985-03-20	77
K843197	VISITEC EYE SHIELD	Visitec Co.	1984-10-05	52
K803145	CONPHAR EYE PROTECTOR	Conphar, Inc.	1981-02-05	55
K802799	EYE PADS	Secol Co.	1980-12-17	43
K801995	EYE PADS CAT.#581-599	Pollak (Intl.), Ltd.	1980-09-09	20
K800404	MEDSPEC OPERATIVE OPTHALMIC KIT	Medi-Spec	1980-04-24	58
K781539	ISO-CARE KIT	Nice-Pak Products, Inc.	1978-11-03	56

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