# Cardinal Health, Inc.

- Location (FDA's records): Waukegan, IL
- FDA decisions: 28 (2006–2022): 28 510(k) clearances
- Names in FDA's records: Cardinal Health, Inc. (26); Cardinal Health, LLC (2)
- Product codes: KGO (13), LZA (3), NDN (2), EOQ (1), LZH (1), BTT (1), FYA (1), GCJ (1), LYZ (1), GZT (1), GYC (1), KKX (1)
- 510(k) review time since 2016: median 160 days, against 163 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 36 (6 its own); citations of its devices by later devices: 33 (6 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Allegiance Healthcare Corp.: 10 (https://510kreport.com/company/allegiance-healthcare)
- Cardinalhealth: 3 (https://510kreport.com/company/cardinalhealth)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Kyphon, Inc.: 2 (https://510kreport.com/company/kyphon)
- Plastimed Laboratoire Pharmaceutique: 1 (https://510kreport.com/company/plastimed-laboratoire-pharmaceutique)
- Ballard Medical Products: 1 (https://510kreport.com/company/ballard-medical-products)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Travenol Laboratories, S.A.: 1 (https://510kreport.com/company/travenol-laboratories)

## Firms that cite its devices most
- Care Fusion: 4 (https://510kreport.com/company/care-fusion)
- Shanghai Motex Healthcare Co., Ltd.: 2 (https://510kreport.com/company/shanghai-motex-healthcare)
- Eco Medi Glove Sdn. Bhd.: 2 (https://510kreport.com/company/eco-medi-glove-sdn-bhd)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Cardinal Health 200, Inc.: 1 (https://510kreport.com/company/cardinal-health-200)
- Hometa, Inc.: 1 (https://510kreport.com/company/hometa)
- Cadwell Industries, Inc.: 1 (https://510kreport.com/company/cadwell-industries)
- Osseon Therapeutics, Inc.: 1 (https://510kreport.com/company/osseon-therapeutics)

## Its most-cited devices
- K090211: Inflatable Bone Tamp (2009), cited by 5
- K072964: Nicolet Cortical Stimulator (2008), cited by 4
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug (2011), cited by 3
- K090915: Sterile Water for Inhalation Flex Bag, Usp (2009), cited by 2
- K072133: Avaflex Vertebral Augmentation Needle (2007), cited by 2
- K092684: Laparoscopic Retractors (2010), cited by 2

## Recent decisions
- K221603: Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml  (B5FD );Kangaroo OMNI™ ENtelliSet 500ml  (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml  (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag  (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ (Dec 20, 2022)
- K211765: Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown (Nov 23, 2021)
- K170198: Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) (Jun 15, 2017)
- K160411: Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (Jul 25, 2016)
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (Jul 11, 2016)
- K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (May 12, 2016)
- K122696: Powder-Free Nitrile Examination Gloves (Cool Blue) (Jan 31, 2013)
- K121897: Protexis Latex Basic Sterile Powder-Free Surgical Gloves (Jul 27, 2012)

Source page: https://510kreport.com/company/cardinal-health