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

HRM — Predicate Candidate Screening

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

43 daysmedian FDA review time

177 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K932720	HM-0970	Hill-Med, Inc.	1993-09-07	95
K930439	MARCO SURGISCOPE OPERATION MICROSCOPES	Marco Ophthalmic, Inc.	1993-07-22	177
K920641	ALCON OPERATING MICROSCOPES	Alcon Laboratories	1992-10-09	240
K914956	KEELER KONAN SPECULAR MICROSCOPE SP5500	Keeler Instruments, Inc.	1992-02-03	90
K891584	S 22 INSTRUMENT STAND	Carl Zeiss, Inc.	1989-06-08	80
K891001	MICROSCOPE KNOB COVER, STERILE, DISPOSABLE	Prescott'S, Inc.	1989-04-11	43
K854440	MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50	Keeler Instruments, Inc.	1985-12-16	41
K853855	XTAL X-150 OPERATING MICROSCOPE	Xtal Corp.	1985-10-15	29
K852586	CROMIC SURGICAL MICROSCOPE MODEL MC-1	Seltrex, Corp.	1985-07-30	42
K852150	CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500	Keeler Instruments, Inc.	1985-06-03	17
K850270	CORNEAL LIGHT SHIELD	Mentor O & O, Inc.	1985-05-31	128
K844323	KONAN CLINIC MICROSCOPE CLM-100-150	Keeler Instruments, Inc.	1984-11-21	14
K822563	OPHTHALMIC MICROSCOPE	Treace Medical, Inc.	1982-09-14	21
K792083	HAAG-STREIT SLIT LAMP 900	Lumenis, Inc.	1979-11-16	31

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