# Cardinalhealth

- Location (FDA's records): Waukegan, IL
- FDA decisions: 34 (2003–2026): 33 510(k) clearances and 1 original PMA approval
- Product codes: OMP (7), KGO (4), LZC (3), BZD (2), PIF (2), CAF (2), HCH (1), HSB (1), FMF (1), KTT (1), MYU (1), LYZ (1)
- 510(k) review time since 2016: median 233 days, against 137 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 21 (4 its own); citations of its devices by later devices: 20 (4 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Allegiance Healthcare Corp.: 3 (https://510kreport.com/company/allegiance-healthcare)
- Innovative Therapies, Inc.: 2 (https://510kreport.com/company/innovative-therapies)
- Kci USA, Inc.: 2 (https://510kreport.com/company/kci-usa)
- Covidien: 1 (https://510kreport.com/company/covidien)
- V. Mueller Neuro/Spine: 1 (https://510kreport.com/company/v-mueller-neuro-spine)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)
- Emerge Medical: 1 (https://510kreport.com/company/emerge-medical)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Care Fusion: 5 (https://510kreport.com/company/care-fusion)
- Cardinal Health, Inc.: 3 (https://510kreport.com/company/cardinal-health)
- Biodrain Medical, Inc.: 1 (https://510kreport.com/company/biodrain-medical)
- Doctors Research Group, Inc.: 1 (https://510kreport.com/company/doctors-research-group)
- Medline Industires, Inc.: 1 (https://510kreport.com/company/medline-industires)
- Cardinal Health-Medical Products and Services: 1 (https://510kreport.com/company/cardinal-health-medical-products-and-services)
- Latexx Manufacturing Sdn.Bhd.: 1 (https://510kreport.com/company/latexx-manufacturing-sdn-bhd)
- Applied Medical Technology, Inc.: 1 (https://510kreport.com/company/applied-medical-technology)

## Its most-cited devices
- K043518: Radiopaque Bone Cement (2005), cited by 6
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection (2019), cited by 2
- K150124: Cardinal Health NPWT PRO HC (2015), cited by 2
- K053272: Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves (2006), cited by 1
- K143016: Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home (2015), cited by 1
- K042574: Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol) (2004), cited by 1

## Recent decisions
- K261749: Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Sep 2, 2026)
- K252313: Cardinal Health Nitrile Examination Gloves Extended Cuff (Jan 14, 2026)
- K243660: Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip  (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip  (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip  (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip  (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip  (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip  (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip  (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip  (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip  (8881516937); Monojec (Aug 22, 2025)
- K243652: Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (Dec 19, 2024)
- K230569: Cardinal Health Surgical Mask With Anti-fog Hydrogel  (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel  (Level 1 ) (Jul 3, 2023)
- K213174: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (May 19, 2022)
- K202217: Kendall NPWT Incision Management Device (Jun 4, 2021)
- P190007: Cardinal Health Multifunctional Defibrillation Electrode (Aug 7, 2020)

Source page: https://510kreport.com/company/cardinalhealth