Atlas FDA

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

Raven Biological Laboratories, Inc. · Predicate Candidate Screening

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

91 daysmedian FDA review time
397 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082756RAVEN PROTEST - STEAM BIOLOGICAL INDICATORRaven Biological Laboratories, Inc.2009-10-213970
K062651PROCHEM EXT CHEMICAL INTEGRATORRaven Biological Laboratories, Inc.2007-03-151890
K053212RAVEN PROPACTRaven Biological Laboratories, Inc.2006-02-15910
K050591MODIFICATION TO RAVEN BACTERIAL SPORE STRIPSRaven Biological Laboratories, Inc.2005-03-23152
K041784RAVEN PROTEST - EORaven Biological Laboratories, Inc.2004-09-13740
K041386RAVEN PROTEST - STEAMRaven Biological Laboratories, Inc.2004-08-09760
K032914MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPSRaven Biological Laboratories, Inc.2004-05-252462
K031114PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PARaven Biological Laboratories, Inc.2004-03-033300
K020026RAVEN BACTERIAL SPORE STRIPSRaven Biological Laboratories, Inc.2002-01-30260
K994381PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATORRaven Biological Laboratories, Inc.2001-03-304581
K971430PROSPORE IIRaven Biological Laboratories, Inc.1997-05-22350
K971432PROSPORERaven Biological Laboratories, Inc.1997-05-20330
K962441PROSPORE(STEARO FOR STEAM STERILIZER)Raven Biological Laboratories, Inc.1996-09-18860
K960790PROSPORE IIRaven Biological Laboratories, Inc.1996-08-161720
K912796SPORE STRIPRaven Biological Laboratories, Inc.1992-04-022820

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