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

GDB — Predicate Candidate Screening

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

64 daysmedian FDA review time

223 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K032283	DESIGNS FOR VISION FIBEROPTIC LIGHT	Designs For Vision, Inc.	2003-08-20	27
K961536	FLEXSCOPE	Matrix Medica, Inc.	1996-09-18	149
K935818	ENDOSCOPE	Cuda Products Co.	1994-07-13	223
K882061	OLYMPUS GF-UM3/EU-M3	Olympus Corp.	1988-11-15	183
K855151	FRITCH OPHTHALMIC ENDOSCOPE	Regtec	1986-02-19	55
K843900	FOCUSCOPE UNIVERSAL SYSTEM	Medical Diagnostics, Ca.	1984-12-06	64
K810007	PENTAX UPPER G.I. FIBERSCOPE, #FG-34	Pentax Precision Instrument Corp.	1981-01-15	10

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