Atlas FDA

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

Dana Products, Inc. · Predicate Candidate Screening

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

175 daysmedian FDA review time
365 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133267DANA REUSABLE TEST PACKDana Products, Inc.2014-02-111100
K130135DANA REUSABLE BI TEST PACKDana Products, Inc.2013-11-253110
K120592DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORSDana Products, Inc.2013-02-273650
K110253REUSABLE TEST PACK FOR DANA EMULATING INDICATORSDana Products, Inc.2011-04-29910
K103321DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTEDana Products, Inc.2011-02-16960
K100891DANA EMULATING INDICATORDana Products, Inc.2011-01-132880
K102761DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONDana Products, Inc.2010-12-20880
K092944DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONDana Products, Inc.2010-03-181750
K012195STEAM STERILIZATION INTERGRATORDana Products, Inc.2002-05-072980

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