# Halyard Health, Inc.

- Location (FDA's records): Alpharetta, GA
- FDA decisions: 14 (2014–2019): 14 510(k) clearances
- Names in FDA's records: Halyard Health, Inc. (7); Halyard Health (7)
- Product codes: GXI (2), LZC (2), LZA (2), FYA (2), KNT (1), BXN (1), BSO (1), FRG (1), MEB (1), FXX (1)
- 510(k) review time since 2016: median 125 days, against 155 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 15 (1 its own); citations of its devices by later devices: 15 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kimberly-Clark Corp.: 8 (https://510kreport.com/company/kimberly-clark)
- Baylis Medical Co., Inc.: 2 (https://510kreport.com/company/baylis-medical)
- Life-Tech Intl., Inc.: 1 (https://510kreport.com/company/life-tech-intl)
- Life-Tech, Inc.: 1 (https://510kreport.com/company/life-tech)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- Central Medicare Sdn Bhd: 1 (https://510kreport.com/company/central-medicare-sdn-bhd)

## Firms that cite its devices most
- O&M Halyard, Inc.: 5 (https://510kreport.com/company/o-m-halyard)
- Avanos Medical, Inc.: 2 (https://510kreport.com/company/avanos-medical)
- Owens & Minor (O&M) Halyard, Inc.: 2 (https://510kreport.com/company/owens-minor-o-m-halyard)
- Hunan Heng Chang Pharmaceutical Co., Ltd.: 1 (https://510kreport.com/company/hunan-heng-chang-pharmaceutical)
- 3M Healthcare: 1 (https://510kreport.com/company/3m-healthcare)
- 0 & M Halyard, Inc.: 1 (https://510kreport.com/company/0-m-halyard)
- Owens & Minor Halyard, Inc.: 1 (https://510kreport.com/company/owens-minor-halyard)
- Shandong Shengquan New Material Co., Ltd.: 1 (https://510kreport.com/company/shandong-shengquan-new-material)

## Its most-cited devices
- K143287: Fluidshield* Surgical Mask with Expanded Chamber (2015), cited by 4
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (2018), cited by 3
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), cited by 2
- K153255: Aero Chrome* Breathable Performance Surgical Gown (2016), cited by 2
- K163236: COOLIEF Cooled Radiofrequency Kit (2016), cited by 1
- K153708: Halyard Black-Orange Powder-Free Nitrile Exam Glove (2016), cited by 1

## Recent decisions
- K181360: ON-Q* Pump with Bolus (Mar 22, 2019)
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (Jun 27, 2018)
- K173955: Mic-Key* SF Over-the-Wire Stoma Measuring Device (Jan 26, 2018)
- K162930: Aero Chrome* Select Breathable Performance Surgical Gowns (Apr 21, 2017)
- K163461: Coolief* Cooled RF Probe (Apr 13, 2017)
- K163236: COOLIEF Cooled Radiofrequency Kit (Dec 16, 2016)
- K161232: ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit (Sep 30, 2016)
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (Sep 6, 2016)

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