Owens & Minor (O&M) Halyard, Inc.: FDA clearances and approvals
Owens & Minor (O&M) Halyard, Inc. has 12 FDA 510(k) clearances (first 2019, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time: 256 days. Since 2017 its median was 256 days, against 152 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 63 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 217 |
| 2023 | 0 | — |
| 2024 | 9 | 269 |
| 2025 | 1 | 246 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Owens & Minor (O&M) Halyard, Inc.'s cleared 510(k)s took a median 256 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 8 | 8 |
| FRG | Wrap, Sterilization | 2 | 2 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| MSH | Respirator, Surgical | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Owens & Minor (O&M) Halyard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | FXX | 2025-05-30 | 246 |
| 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) | FXX | 2024-07-02 | 293 |
| 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) | FXX | 2024-07-01 | 294 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | FXX | 2024-06-21 | 283 |
| 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) | FXX | 2024-06-14 | 276 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | FXX | 2024-06-07 | 269 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | FXX | 2024-06-04 | 265 |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | FYC | 2024-05-16 | 245 |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | MSH | 2024-01-12 | 112 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | FXX | 2024-01-08 | 112 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Owens & Minor (O&M) Halyard, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Owens & Minor (O&M) Halyard, Inc. have?
Owens & Minor (O&M) Halyard, Inc. has 12 FDA 510(k) clearances (first 2019, latest 2025), across 4 product codes in 1 review panel.
How long does FDA take to clear Owens & Minor (O&M) Halyard, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Owens & Minor (O&M) Halyard, Inc.'s cleared 510(k)s is 256 days. Since 2017: 256 days, versus 152 days for all cleared 510(k)s in the same product codes.
What devices does Owens & Minor (O&M) Halyard, Inc. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 8); FRG (Wrap, Sterilization, 2); FYC (Gown, Isolation, Surgical, 1).
Has Owens & Minor (O&M) Halyard, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Owens & Minor (O&M) Halyard, Inc. Related entities may recall under other names.
Next steps
- See all 12 Owens & Minor (O&M) Halyard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Owens & Minor (O&M) Halyard, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.