Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

O&M Halyard, Inc. — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

184 daysmedian FDA review time
270 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* O&M Halyard, Inc.2026-07-21360
K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* TecO&M Halyard, Inc.2026-07-02270
K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK*O&M Halyard, Inc.2026-05-182270
K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFTO&M Halyard, Inc.2026-03-182650
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EO&M Halyard, Inc.2025-12-11870
K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low DeO&M Halyard, Inc.2025-08-182700
K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile PaiO&M Halyard, Inc.2025-06-182610
K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured O&M Halyard, Inc.2024-12-171110
K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low DermatiO&M Halyard, Inc.2024-09-27880
K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®O&M Halyard, Inc.2024-09-162700
K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMAO&M Halyard, Inc.2024-08-071840
K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low DermaO&M Halyard, Inc.2024-03-222660
K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-FO&M Halyard, Inc.2022-08-162430
K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for UO&M Halyard, Inc.2022-08-012280
K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARO&M Halyard, Inc.2022-06-02970
K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMO&M Halyard, Inc.2022-06-02970
K203177Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc.2022-01-024330
K211063HALYARD Flexaprene Green Powder-Free Exam GloveO&M Halyard, Inc.2021-11-192240
K210688AERO CHROME* Select Breathable Performance Surgical Gown, AEO&M Halyard, Inc.2021-07-211350
K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free ExamO&M Halyard, Inc.2021-01-071190
K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam GloveO&M Halyard, Inc.2020-09-221750
K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.2020-03-16140
K192362Aero Blue Performance Surgical GownsO&M Halyard, Inc.2019-12-131051
K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard SO&M Halyard, Inc.2019-11-081840
K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for UseO&M Halyard, Inc.2019-06-262590
K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove TesteO&M Halyard, Inc.2019-02-05840

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