# K141071: Kimguard One-Step Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Health Care
- Decided: Jul 28, 2014 after 94 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). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 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.
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600, Kimberly-Clark Corp. (2009) Summary page 1.

## 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
- K240438: CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (2024), 0 descendants of its own
- K230137: Reliance® Fusion Sterilization Wraps (2023), 0 descendants of its own

## Indications for use
KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, K0200, 1(0300, 1(0400, KC0500 and 1(0600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using: *Gravity Steam at 250*F/121*O for 30 minutes. KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, 1(0200, 1(0300, 1(0400, 1(0500 and 1(0600) 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 t ONE-STEP* Sterilization Wrap (1(0100, 1(0200, 1(0300, 1(0400, KC0500 and 1(0600) allowed sterilization of the enclosed devices by the Gravity Steam Sterilization Systems (250*F/121*C for 30 minutes). 1(IMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use within Gravity Steam Systems are provided in Table 1.

Source page: https://510kreport.com/device/K141071
Methodology: https://510kreport.com/methodology