# Owens & Minor (O&M) Halyard, Inc.

- Location (FDA's records): Mechanicsville, VA
- FDA decisions: 12 (2019–2025): 12 510(k) clearances
- Product codes: FXX (8), FRG (2), FYC (1), MSH (1)
- 510(k) review time since 2016: median 267 days, against 263 for FDA's reviews in the same codes and years (2 of 10 faster)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 3 (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.: 7 (https://510kreport.com/company/kimberly-clark)
- Halyard Health, Inc.: 2 (https://510kreport.com/company/halyard-health)
- Primed Medical Products, Inc.: 1 (https://510kreport.com/company/primed-medical-products)
- Tecnol Medical Products, Inc.: 1 (https://510kreport.com/company/tecnol-medical-products)

## Firms that cite its devices most
- O&M Halyard, Inc.: 2 (https://510kreport.com/company/o-m-halyard)

## Its most-cited devices
- K214007: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (2022), cited by 1
- K232777: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) (2024), cited by 1
- K192147: Halyard ONE-STEP* Sterilization Wrap (2019), cited by 1

## Recent decisions
- K243010: Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (May 30, 2025)
- K232824: FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) (Jul 2, 2024)
- K232777: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) (Jul 1, 2024)
- K232807: Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) (Jun 21, 2024)
- K232812: Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) (Jun 14, 2024)
- K232806: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) (Jun 7, 2024)
- K232820: HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) (Jun 4, 2024)
- K232849: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (May 16, 2024)

Source page: https://510kreport.com/company/owens-minor-o-m-halyard