# K192147: Halyard ONE-STEP* Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Owens & Minor (O&M) Halyard, Inc.
- Decided: Oct 10, 2019 after 63 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: 5 generations back to K881471 (1988). 6 ancestors in all.
4 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)
- K141712: Kimguard One Step Sterilization Wrap, Halyard Health (2014) Summary page 4.

## Most influential descendants
- K214007: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (2022), 3 descendants of its own
- 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
The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below: Lumen Cycle: Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions: Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long; and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load). Flexible Cycle: Reusable rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors; Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).

Source page: https://510kreport.com/device/K192147
Methodology: https://510kreport.com/methodology