DeviceClearance

HALYARD* ONE-STEP* Sterilization Wrap +3 more— 510(k) K253454

Substantially Equivalent

O&M Halyard, Inc.

FDA 510(k) clearance K253454 for HALYARD* ONE-STEP* Sterilization Wrap +3 more, Substantially Equivalent on 2026-05-18. Applicant: O&M Halyard, Inc.. Device class: 2.

Summary

O&M Halyard's record lists four HALYARD sterilization wraps: ONE-STEP, QUICK CHECK, SEQUENTIAL and SMART-FOLD. The product code is FRG, sterilization wraps.

Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Halyard filed from Alpharetta, Georgia. Review took 227 calendar days (October 3, 2025 to May 18, 2026).

Clearance details

Device name as filed
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
Applicant
O&M Halyard, Inc.
Product code
Product code FRG
Device class
Class 2
Regulation
21 CFR 880.6850
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FRG

product code FRG
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.