# Cardinal Health200, LLC

- Location (FDA's records): Waukegan, IL
- FDA decisions: 26 (2011–2024): 26 510(k) clearances
- Product codes: FRG (11), FYA (4), FXX (3), LZA (2), MEG (1), KKX (1), QPC (1), JOW (1), FYC (1), KGO (1)
- 510(k) review time since 2016: median 118 days, against 137 for FDA's reviews in the same codes and years (6 of 12 faster)
- Predicates its devices cite: 27 (13 its own); citations of its devices by later devices: 36 (13 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kimberly-Clark Corp.: 7 (https://510kreport.com/company/kimberly-clark)
- Cardinal Health-Medical Products and Services: 2 (https://510kreport.com/company/cardinal-health-medical-products-and-services)
- American Threshold Industries, Inc.: 2 (https://510kreport.com/company/american-threshold-industries)
- Tyco Healthcare: 1 (https://510kreport.com/company/tyco-healthcare)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)

## Firms that cite its devices most
- Cardinal Health-Medical Products and Services: 3 (https://510kreport.com/company/cardinal-health-medical-products-and-services)
- Dukal Corp.: 2 (https://510kreport.com/company/dukal)
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Primed Medical Products, Inc.: 1 (https://510kreport.com/company/primed-medical-products)
- Jingzhou Haixin Green Cross Medical Products Co., Ltd.: 1 (https://510kreport.com/company/jingzhou-haixin-green-cross-medical-products)
- Allmed Medical (Hubei) Protective Products Co., Ltd.: 1 (https://510kreport.com/company/allmed-medical-hubei-protective-products)
- Shandong Zhushi Pharmaceutical Group Co., Ltd.: 1 (https://510kreport.com/company/shandong-zhushi-pharmaceutical-group)
- Hubei Wanli Protective Products Co., Ltd.: 1 (https://510kreport.com/company/hubei-wanli-protective-products)

## Its most-cited devices
- K170762: Cardinal Health Non-Reinforced Surgical Gown (2017), cited by 8
- K160339: Cardinal Health Isolation Gown (2016), cited by 4
- K120658: Durablue Sterilization Wrap (2012), cited by 3
- K192374: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (2019), cited by 2
- K112283: Dura Blue Sterilization Wrap (2011), cited by 2
- K112211: Dura Blue Sterilization Wrap (2011), cited by 2

## Recent decisions
- K241780: Cardinal Health Nitrile Exam Gloves (Aug 23, 2024)
- K230838: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets (Jul 27, 2023)
- K223376: Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) (Jun 21, 2023)
- K230028: Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (Apr 3, 2023)
- K201592: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove (Sep 26, 2021)
- K211390: Nitrile Blue Powder-free Examination Glove (Aug 28, 2021)
- K200824: Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown (Jul 29, 2020)
- K193327: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (Mar 20, 2020)

Source page: https://510kreport.com/company/cardinal-health200