FDA applicant
O&M Halyard, Inc.
FDA records 26 decisions for O&M Halyard, Inc. (Alpharetta, GA) from 2019 to 2026: 26 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 180 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 9 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided O&M Halyard, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like O&M Halyard, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report