Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Halyard Health, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
184 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | Halyard Health, Inc. | 2018-01-26 | 29 | 0 |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | Halyard Health, Inc. | 2017-04-21 | 184 | 0 |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | 2017-04-13 | 125 | 0 |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016-12-16 | 29 | 0 |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health, Inc. | 2016-04-13 | 155 | 0 |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health, Inc. | 2015-03-24 | 127 | 0 |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | 2015-03-24 | 147 | 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