Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Owens & Minor (O&M) Halyard, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
265 daysmedian FDA review time
293 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti- | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 | 246 | 0 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining | Owens & Minor (O&M) Halyard, Inc. | 2024-07-02 | 293 | 0 |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SO | Owens & Minor (O&M) Halyard, Inc. | 2024-07-01 | 294 | 0 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SO | Owens & Minor (O&M) Halyard, Inc. | 2024-06-21 | 283 | 0 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* | Owens & Minor (O&M) Halyard, Inc. | 2024-06-14 | 276 | 0 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining a | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 | 269 | 0 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft | Owens & Minor (O&M) Halyard, Inc. | 2024-06-04 | 265 | 0 |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Ha | Owens & Minor (O&M) Halyard, Inc. | 2024-05-16 | 245 | 0 |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and | Owens & Minor (O&M) Halyard, Inc. | 2024-01-12 | 112 | 0 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber | Owens & Minor (O&M) Halyard, Inc. | 2024-01-08 | 112 | 0 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Ste | Owens & Minor (O&M) Halyard, Inc. | 2022-07-27 | 217 | 0 |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019-10-10 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda