# K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Sep 3, 2009 after 85 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.
32 later devices descend from it; 4 cite it directly.
0 of 35 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
- K112211: Dura Blue Sterilization Wrap (2011), 11 descendants of its own
- K120658: Durablue Sterilization Wrap (2012), 9 descendants of its own
- K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization (2012), 8 descendants of its own
- K141071: Kimguard One-Step Sterilization Wrap (2014), 7 descendants of its own

## Indications for use
The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/1 32 0C for 4 minutes. 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 KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization of 30 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization. The KC 300 Model KIMGUARD ONE-STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene oxide sterilization method of 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55 0C and 40% - 80% relative humidity for 60 minutes. See KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for pre-vacuum steam on Page 2.

Source page: https://510kreport.com/device/K091685
Methodology: https://510kreport.com/methodology