O&M Halyard, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “O&M Halyard, Inc.” (first 2019, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 180 days. Since 2017 the median was 180 days, against 129 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 4 | 144 |
| 2020 | 2 | 94 |
| 2021 | 3 | 135 |
| 2022 | 5 | 228 |
| 2023 | 0 | — |
| 2024 | 5 | 184 |
| 2025 | 3 | 261 |
| 2026 | 4 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name O&M Halyard, Inc. took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 14 | 14 |
| FRG | Wrap, Sterilization | 4 | 4 |
| FYA | Gown, Surgical | 3 | 3 |
| FXX | Mask, Surgical | 2 | 2 |
| LZC | Medical Glove, Specialty | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- General Hospital (26)
Most recent O&M Halyard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | LZA | 2026-07-21 | 36 |
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | FRG | 2026-07-02 | 27 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | FRG | 2026-05-18 | 227 |
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | FXX | 2026-03-18 | 265 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | FXX | 2025-12-11 | 87 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | LZA | 2025-08-18 | 270 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | LZA | 2025-06-18 | 261 |
| K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 2024-12-17 | 111 |
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 2024-09-27 | 88 |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | FRG | 2024-09-16 | 270 |
16 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 7 recall events; 7 initiated in the last five years. Most recent: 2026-04-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under O&M Halyard, Inc.?
FDA lists 26 510(k) clearances under the applicant name “O&M Halyard, Inc.” (first 2019, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by O&M Halyard, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O&M Halyard, Inc. is 180 days. Since 2017: 180 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under O&M Halyard, Inc.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 14); FRG (Wrap, Sterilization, 4); FYA (Gown, Surgical, 3).
Next steps
- See all 26 O&M Halyard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZA, O&M Halyard, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.