# K214007: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Owens & Minor (O&M) Halyard, Inc.
- Decided: Jul 27, 2022 after 217 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: 6 generations back to K881471 (1988). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192147: Halyard ONE-STEP* Sterilization Wrap, Owens & Minor (O&M) Halyard, Inc. (2019) Summary page 5.

## Most influential descendants
- K234050: HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (2024), 2 descendants of its own
- 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 (2026), 0 descendants of its own
- K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap (2026), 0 descendants of its own

## Indications for use
HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1. The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Stryker Sterizone VP4 Sterilizer Cycle I. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterizone VP4 Sterilizer Cycle 1 as described below:

Source page: https://510kreport.com/device/K214007
Methodology: https://510kreport.com/methodology