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

KGL · Predicate Candidate Screening

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

59 daysmedian FDA review time

120 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K852575	WALDMANN F85/100W PUVA	Sylvania Lighting Products	1985-08-16	59
K841795	UV 8001K, PUVA 800, PUVA 180/200 1000	Waldmann Lighting Co.	1984-08-30	120
K820280	SPECTRA 305/350	Ultralite	1982-03-05	31
K810668	HO-B-LITE VI UNIT	National Biological Corp.	1981-04-23	42
K810358	PHOTOTHERAPY LIGHT CHAMBER	Paul B. Elder Co.	1981-03-20	38
K791977	PSORALITE MARK I	Paul B. Elder Co.	1979-12-28	87
K791116	PSORALITE SERIES 30,000	Paul B. Elder Co.	1979-09-04	81
K761094	UVA PHOTOTHERAPY SYSTEM	Dermatron Corp.	1976-12-02	9

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