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

Philips Int'L B.V. — Predicate Candidate Screening

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

15 daysmedian FDA review time

34 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K920134	PHILIPS 41 SERIES RAINBOW	Philips Int'L B.V.	1992-01-24	11
K920142	PHILIPS M60 SERIES	Philips Int'L B.V.	1992-01-23	10
K852348	PHILIPS SOLARIUM HP 3134	Philips Int'L B.V.	1985-06-27	27
K851534	PHILIPS UV-A SOLARIUM TYPE HP 3150	Philips Int'L B.V.	1985-05-01	15
K851533	PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP	Philips Int'L B.V.	1985-05-01	15
K851535	PHILIPS UV-A SOLARIUM TYPE HP 3140	Philips Int'L B.V.	1985-05-01	15
K851536	PHILIPS UV-A SOLARIUM TYPE HP 3141	Philips Int'L B.V.	1985-05-01	15
K850206	PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP	Philips Int'L B.V.	1985-02-21	34
K850205	PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP	Philips Int'L B.V.	1985-02-21	34
K850204	PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP	Philips Int'L B.V.	1985-02-21	34
K850203	PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP	Philips Int'L B.V.	1985-02-21	34

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