# K082554: Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: May 1, 2009 after 240 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: 1 generation back to K881471 (1988). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881471: Kimguard (Regular & Heavy Duty) Sterile Wrap, Kimberly-Clark Corp. (1988) Summary page 2.

## Most influential descendants
- K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (2016), 6 descendants of its own
- K171533: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (2017), 2 descendants of its own
- K182656: JAMBRO Single Core A Sterilization wrap (2019), 1 descendant of its own
- K143053: KIMGUARD ONE-STEP Sterilization Wrap (2015), 1 descendant of its own
- K240438: CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (2024), 0 descendants of its own

## Indications for use
KIMGUARD* 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-C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55-C and 40% - 80% relative humidity for 60 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 wrap was validated for aeration times for EtO sterilization of 8 hours at 55 QC or 12 hours at 43.3 QC. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500., and 600. KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization. See Wrap Model Recommendations on Page 2.

Source page: https://510kreport.com/device/K082554
Methodology: https://510kreport.com/methodology