Atlas FDA

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

ONT · Predicate Candidate Screening

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

284 daysmedian FDA review time
736 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc.2015-12-292840
K122702BIOFRIEND BIOMASK N95 SURGICAL RESPIRATORFilligent Limited2013-03-181950
K120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.2012-07-051600
K090414SPECTRASHIELD 9500 SURGICAL MASKNexera Medical, Inc.2011-02-247360
K093161ACTIPROTECT UF N95 RESPIRATORGlaxosmithkline Consumer Healthcare2010-05-102160
K081923ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLDGlaxosmithkline Consumer Healthcare2009-07-013590

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