# K142782: KIMGUARD ONE-STEP Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Health Care
- Decided: Mar 9, 2015 after 164 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: 4 generations back to K881471 (1988). 5 ancestors in all.
2 later devices descend 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)
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600, Kimberly-Clark Corp. (2009) Summary page 5.
- K112805: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2012) Summary page 5.

## Most influential descendants
- K181959: HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) (2019), 1 descendant of its own
- K240330: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) (2024), 0 descendants of its own

## Indications for use
KIMGUARD® ONE-STEP Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: V-PRO® 60 Low Temperature Sterilization System that include: Lumen Cycle Non Lumen Cycle Flexible Cycle KIMGUARD® ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used. Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD® ONE-STEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles. All models of the KIMGUARD® ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in TABLE 1. KIMGUARD ONE-STEP Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in Table 2.

Source page: https://510kreport.com/device/K142782
Methodology: https://510kreport.com/methodology