Atlas FDA

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

Cardinal Health, Alaris Products · Predicate Candidate Screening

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

79 daysmedian FDA review time
207 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071400SMARTSITE STOPCOCKCardinal Health, Alaris Products2007-12-142070
K071108TEXIUM SYRINGECardinal Health, Alaris Products2007-05-24351
K061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSCardinal Health, Alaris Products2006-07-26790
K053049ALARIS SAFETY MALE LUERCardinal Health, Alaris Products2006-01-12763
K052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDCardinal Health, Alaris Products2005-12-23810
K051641ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products2005-10-2012222
K050115BLOOD HAND PUMP ADMINISTRATION SETCardinal Health, Alaris Products2005-04-01730
K043590SE INFUSION SYSTEM WITH MMSCardinal Health, Alaris Products2005-03-25871
K050230TURBO TEMP TRIOCardinal Health, Alaris Products2005-02-16150

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