Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Burton Medical Products Corp. · Predicate Candidate Screening

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

90 daysmedian FDA review time

140 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K101537	AIM 200, MAJOR SURGICAL LIGHT	Burton Medical Products Corp.	2010-09-30	119	0
K042395	OUTPATIENT III MINOR SURGERY LIGHT	Burton Medical Products Corp.	2004-12-01	90	0
K000639	VISIONARY 2000	Burton Medical Products Corp.	2000-05-25	90	0
K963682	GENIE' SINGLE CEILING AND DOUBLE CEILING	Burton Medical Products Corp.	1996-11-13	71	0
K961843	GENIE	Burton Medical Products Corp.	1996-08-22	101	0
K935102	SATURN LIGHT	Burton Medical Products Corp.	1994-06-27	248	0
K942553	GENESIS	Burton Medical Products Corp.	1994-06-23	23	0
K936088	WAVE FLUORESCENT MAGNIFIER	Burton Medical Products Corp.	1994-04-26	126	0
K931645	HALUX TASKLIGHT	Burton Medical Products Corp.	1993-08-20	140	0
K901706	LIGHT, HEAD, EXAMINATION	Burton Medical Products Corp.	1990-07-19	98	0
K893807	MODEL 0183010, PEARL MEDICAL EXAM LIGHT	Burton Medical Products Corp.	1989-08-15	85	0
K893808	MODEL 0450000, OPAL MEDICAL EXAM LIGHT	Burton Medical Products Corp.	1989-08-15	85	0
K861289	BASIC LIGHT	Burton Medical Products Corp.	1986-04-18	11	0
K860088	PL EXAM LIGHT	Burton Medical Products Corp.	1986-01-24	14	0
K851742	MEDICAL EXAMINATION LIGHTS	Burton Medical Products Corp.	1985-05-13	14	1

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