Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Halyard Health · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
304 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019-03-22 | 304 | 0 |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for U | Halyard Health | 2018-06-27 | 107 | 0 |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic | Halyard Health | 2016-09-30 | 151 | 0 |
| K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | Halyard Health | 2016-09-06 | 176 | 0 |
| K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | Halyard Health | 2016-03-31 | 99 | 0 |
| K150113 | Fusion Black Powder-Free Nitrile Exam Glove | Halyard Health | 2015-06-18 | 149 | 0 |
| K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | Halyard Health | 2014-12-18 | 176 | 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