# 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

- Pathway: 510(k) (Traditional)
- Applicant: O&M Halyard, Inc.
- Decided: Jul 2, 2026 after 27 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 8.

## Indications for use
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology, STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, and H300W Sterilization Wrap with ASSURE-DRY * Technology are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * Pre-vacuum steam * The wrap was validated for dry times of 20 minutes with the moisture managing amber layer on the inside, and for 30 minutes with the moisture managing amber layer on the outside. * 270°F/132°C for 4 minutes * 270°F/132°C for 10 minutes * 273.2°F/134°C for 3 minutes * 273.2°F/134°C for 18 minutes * 275°F/135°C for 3 minutes » 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® maX (Lumen, Non-Lumen and Flexible Cycles) * STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycles) » Advanced Sterilization Products STERRAD® Sterilization System * STERRAD® 100NX® (Standard Cycle) * STERRAD® 100NX® with ALLClear® Technology (Standard Cycle)

Source page: https://510kreport.com/device/K261897
Methodology: https://510kreport.com/methodology