# K112805: Kimguard One-Step Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jun 22, 2012 after 269 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: 3 generations back to K881471 (1988). 4 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 23 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 2.
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600, Kimberly-Clark Corp. (2009) Summary page 2.
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600, Kimberly-Clark Corp. (2009) Summary page 2.

## Most influential descendants
- K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (2016), 6 descendants of its own
- K141712: Kimguard One Step Sterilization Wrap (2014), 5 descendants of its own
- K192147: Halyard ONE-STEP* Sterilization Wrap (2019), 4 descendants of its own
- 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

## Indications for use
KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F/1 3200 for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mgIL at 131 0F/55 0 0 and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco@ V-PROM 1 Low Temperature Sterilization System's cycle, the Amsco@ V-PROM 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cycle) and Non Lumen Cycles, and the V-PROTM Low Temperature Sterilization System's Flexible Cycle. 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 within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55COC or 12 hours at 43.3 0C. The KIMGUARD ONE-STEP* Sterilization Wrap were validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP t Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO , V-Pp 0 TM 1 Plus, and the V-PROTM Flexible Sterilization Cycles. KIMGUARD ONE-STEP t Sterilization Wraps are not indicated for use for gravity steam sterilization.

Source page: https://510kreport.com/device/K112805
Methodology: https://510kreport.com/methodology