# K181959: HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

- Pathway: 510(k) (Traditional)
- Applicant: Owens & Minor Halyard, Inc.
- Decided: Mar 22, 2019 after 242 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142782: KIMGUARD ONE-STEP Sterilization Wrap, Kimberly-Clark Health Care (2015) Summary page 9.

## Most influential descendants
- K240330: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) (2024), 0 descendants of its own

## Indications for use
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles: • STERIS V-PRO 1 low temperature sterilization system (lumen cycle), • STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), • STERIS V-PRO maX low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle), • STERIS V-PRO 60 low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle) • STERIS V-PRO maX 2 low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle) HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to allow terminal sterilization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterility of the enclosed device(s) until used within the period of time for which performance data demonstrating maintenance of sterility has been provided.

Source page: https://510kreport.com/device/K181959
Methodology: https://510kreport.com/methodology