# K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Nov 2, 2009 after 104 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: 2 generations back to K881471 (1988). 2 ancestors in all.
35 later devices descend from it; 7 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082177: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2009) Summary page 1.

## Most influential descendants
- K112805: Kimguard One-Step Sterilization Wrap (2012), 18 descendants of its own
- K112918: Durablue Sterilization (Amsco V-Pro) Wrap (2012), 10 descendants of its own
- K112283: Dura Blue Sterilization Wrap (2011), 10 descendants of its own
- K113806: Kimguard One Step Sterilization Wrap (2013), 9 descendants of its own
- K120658: Durablue Sterilization Wrap (2012), 9 descendants of its own

## Indications for use
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles. KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are provided on Page 2.

Source page: https://510kreport.com/device/K092167
Methodology: https://510kreport.com/methodology