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

Mallinckrodt Inc., Liebel-Flarsheim Business · Predicate Candidate Screening

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

158 daysmedian FDA review time
412 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082212SYRINGE WITH HANDI-FILMallinckrodt Inc., Liebel-Flarsheim Business2009-01-221690
K073592OPTISTAR ELITE INJECTION SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business2008-05-071390
K063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATIONMallinckrodt Inc., Liebel-Flarsheim Business2007-04-271581
K042744OPTIV ANTAGE DH POWER INJECTION SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business2004-11-30571
K031339OPTIBOLUSMallinckrodt Inc., Liebel-Flarsheim Business2003-07-11741
K022116ELPH INJECTION SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business2002-07-26250
K984088OPTISTAR MR INJECTOR SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business1999-12-063855
K963071ANGIOMAT ILLUMENAMallinckrodt Inc., Liebel-Flarsheim Business1997-09-234122

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