Atlas FDA

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

Cardinal Health200, LLC · Predicate Candidate Screening

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

121 daysmedian FDA review time
229 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241780Cardinal Health Nitrile Exam GlovesCardinal Health200, LLC2024-08-23640
K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown wiCardinal Health200, LLC2023-07-271220
K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (888Cardinal Health200, LLC2023-06-212290
K230028Kendall SCD SmartFlow Controller, Cardinal Health Element SlCardinal Health200, LLC2023-04-03893
K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloCardinal Health200, LLC2021-09-264710
K211390Nitrile Blue Powder-free Examination GloveCardinal Health200, LLC2021-08-281150
K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, CardinalCardinal Health200, LLC2020-07-291210
K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, CCardinal Health200, LLC2020-03-201091
K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StCardinal Health200, LLC2019-12-02940
K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC2019-04-262030
K181174Cardinal Health Sterilization WrapCardinal Health200, LLC2018-12-112230
K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC2017-06-098817
K161910Cardinal Health Sterilization WrapCardinal Health200, LLC2017-04-202820
K160339Cardinal Health Isolation GownCardinal Health200, LLC2016-07-281712
K151445Cardinal Health Sterilization WrapCardinal Health200, LLC2015-12-212060
K151788Cardinal Health Sterilization WrapCardinal Health200, LLC2015-10-301210
K142990Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC2015-03-041390
K140155SECURE-GARD SURGICAL AND PROCEDURE FACE MASKCardinal Health200, LLC2014-06-201490
K130404TIBURON SURGICAL DRAPECardinal Health200, LLC2013-07-051360
K130927DURABLUE STERILIZATION WRAPCardinal Health200, LLC2013-06-18760
K123857DURABLUE STERILIZATION WRAPCardinal Health200, LLC2013-01-23400
K122507DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH3Cardinal Health200, LLC2012-09-26400
K120658DURABLUE STERILIZATION WRAPCardinal Health200, LLC2012-06-131000
K112918DURABLUE STERILIZATION (AMSCO V-PRO) WRAPCardinal Health200, LLC2012-01-201090
K112283DURA BLUE STERILIZATION WRAPCardinal Health200, LLC2011-10-20720
K112211DURA BLUE STERILIZATION WRAPCardinal Health200, LLC2011-10-20790

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