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

FSO — Predicate Candidate Screening

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

43 daysmedian FDA review time

302 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K942304	MICROFLEX	Moeller Microsurgical, Inc.	1994-06-13	31
K941399	OPERATING MICROSCOPE AA OM 10	Appasamy Associates (U.S.A.), Inc.	1994-04-22	31
K920689	DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM	Deemed, Inc.	1993-11-12	637
K926288	SOM 6VI (SURGICAL OPERATING MICROSCOPE)	Jedmed Instrument Co.	1993-10-12	302
K931303	WOODLYN OPERATION MICROSCOPE	Woodlyn, Inc.	1993-06-25	102
K926513	MOLLER-WEDEL OPERATING MICROSCOPE	Moeller Microsurgical, Inc.	1993-06-22	174
K910357	SOM 6V	Jedmed Instrument Co.	1991-02-19	21
K902076	J2 MICROSCOPE	Jedmed Instrument Co.	1990-08-01	85
K874241	OPMI MD SURGICAL MICROSCOPE	Carl Zeiss, Inc.	1987-12-23	69
K822562	ODONTO-SCOPE	Treace Medical, Inc.	1982-10-06	43
K822181	BINOCULAR OPER. MICROSCOPES & ACCESSOR	Kelleher Corp.	1982-08-27	35
K822015	BINOCULAR OPERATING MICROSCOPES AND	Kelleher Corp.	1982-07-30	22
K802713	FMS-02 FLOOR-UNIT MODEL MICROSCOPE	Jedmed Instrument Co.	1980-11-19	19
K801314	VOCON MODEL VC526	Teknar, Inc.	1980-09-09	98
K791280	OPERATION MICROSCOPE SOM 1	Elmed, Inc.	1979-07-24	14

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