# K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: O&M Halyard, Inc.
- Decided: May 18, 2026 after 227 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K881471 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234050: HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap, O&M Halyard, Inc. (2024) Summary page 17.

## Indications for use
Indication for Use (QUICK CHECK, ONE-STEP and SEQUENTIAL): HALYARD ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: • Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. • 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C. • STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles. • STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles) • STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles) • STERIS V-PRO® 1 (Lumen Cycle) • STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycles) • STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycles) • STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycles) • Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 300 and 30 minute dry time for Models 400, 500, and 600) • Advanced Sterilization Products STERRAD® Sterilization System • STERRAD® 50, 100S, and 200 • STERRAD® NX®, (Standard Cycle, Advanced Cycle) • STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle) • STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle) • STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle) • STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles) • Stryker Sterizone® VP4 Sterilizer Cycle 1 Indication For Use (SMART-FOLD): HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: - Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes. - 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/55°C or 12 hours at 110°F/43.3°C. STERIS V-PRO® Low Temperature Sterilization Systems. • STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles) • STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles) • STERIS® V-PRO® 1 (Lumen Cycle) • STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle) • STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle) • STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle) - Advanced Sterilization Products STERRAD® Sterilization System • STERRAD® 100S • STERRAD® NX®, (Standard Cycle, Advanced Cycle) • STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle) • STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle) • STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)

Source page: https://510kreport.com/device/K253454
Methodology: https://510kreport.com/methodology