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

EPT — Predicate Candidate Screening

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

43 daysmedian FDA review time

101 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K942233	MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM	Carl Zeiss, Inc.	1994-07-01	53
K931284	MICRODYNE OFFICE SURGICAL MICROSCOPE	Microdyne, Inc.	1993-11-18	280
K933310	MICRINS CONTRAST BACKGROUND MATERIAL	Micrins Surgical, Inc.	1993-08-19	43
K903412	STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.	Storz Instrument Co.	1990-09-20	52
K883581	OPMI CS	Carl Zeiss, Inc.	1988-09-13	22
K882269	STORZ DIAGNOSTIC MICROSCOPE SYSTEM	Storz Instrument Co.	1988-06-23	23
K860811	ZEISS VOICE CONTROL SYSTEM FOR OPMI'S	Carl Zeiss, Inc.	1986-04-30	57
K844858	STORZ/URBAN SURGICAL MICROSCOPE SYSTEM	Storz Instrument Co.	1985-03-25	101
K832887	ELECTRONIC UNIT	Surgi-Quip Inc.U	1983-10-04	39
K823011	VC III	Teknar, Inc.	1982-11-08	26
K822561	MICROSCOPE	Treace Medical, Inc.	1982-09-14	21
K822014	NAGASHIMA SU-A CEILING MOUNT UNIT FOR	Kelleher Corp.	1982-08-06	29
K822009	BINOCULAR OPERATING MICROSCOPES &	Kelleher Corp.	1982-07-30	22
K821689	LEBANON MICROSCOPE	The Lebanon Corp.	1982-07-09	31
K812234	STORZ/OLYMPUS MICROSCOPE SYSTEM	Storz Instrument Co.	1981-09-11	31
K802904	MICROSCOPE MODEL OM-U	Jedmed Instrument Co.	1981-02-04	79
K802903	MICROSCOPE MODEL OM-P	Jedmed Instrument Co.	1981-02-04	79
K760696	REMOTE CONTROL SYSTEM FOR MICROSCOPE	Alcon Laboratories	1976-12-16	85

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