HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

FDA cleared the HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap from O&M Halyard, Inc. on May 18, 2026 under K253454, a traditional 510(k). The device falls under product code FRG, Wrap, Sterilization, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Oct 3, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

O&M Halyard, Inc. has 4 other decisions in the tracker over the last 12 months: K262014 (PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves), K261897 (HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology), K251967 (HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor), K252941 (HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops).