Atlas FDA

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

Philips Lighting Co. — Predicate Candidate Screening

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

75 daysmedian FDA review time
90 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021092PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILPhilips Lighting Co.2002-05-16420
K021514PHILIPS PLS9W/12/2P UVBPhilips Lighting Co.2002-05-1670
K940672CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL10Philips Lighting Co.1994-03-18300
K935840TL 20W/12/RS & TL 40W/12/RSPhilips Lighting Co.1994-02-24790
K922963TL100W/12Philips Lighting Co.1992-09-02750
K910767TL100W/01 UVB LAMPPhilips Lighting Co.1991-05-23900

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