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

EBA — Predicate Candidate Screening

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

61 daysmedian FDA review time

107 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K070287	PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200	Photonic Optische Gerate GmbH & Cokg	2007-02-12	14
K923949	SYLVAN DENTAL HEADLIGHT SYSTEM	Sylvan Medical Fiberoptics	1992-10-16	72
K893458	FIBEROPTIC HEADLIGHT SYSTEM	Cuda Products Co.	1989-06-22	51
K854646	VEGA DENTAL OPERATING LIGHT	Alpine Dental Equipment Co.	1986-03-06	107
K842515	SURGICAL HEADLIGHT	Good-Lite Co.	1984-08-02	51
K842358	ISOLIGHT	Planmeca USA, Inc.	1984-07-31	39
K822265	FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS	Kelleher Corp.	1982-09-28	61
K810117	HALOGEN HEADLIGHT SYSTEM	Colmed, Ltd.	1981-02-10	25
K790806	PORCELIT	Harry J. Bosworth Co.	1979-08-03	101
K790807	METALIT	Harry J. Bosworth Co.	1979-08-03	101

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