# K141612: Kimguard One-Step Sterilization Wrap

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Health Care
- Decided: Aug 7, 2014 after 52 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: 4 generations back to K881471 (1988). 4 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K113806: Kimguard One Step Sterilization Wrap, Kimberly-Clark Health Care (2013) Summary page 7.

## 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 Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using: Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cycle, Advanced Cycle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle] KIMGUARD* ONE-STEP* Sterilization Wraps 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* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]). The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1. KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

Source page: https://510kreport.com/device/K141612
Methodology: https://510kreport.com/methodology