# K881471: Kimguard (Regular & Heavy Duty) Sterile Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Aug 10, 1988 after 125 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082177: Kimguard One-Step Sterilization Wrap (2009), 44 descendants of its own
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 (2009), 35 descendants of its own
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 (2009), 32 descendants of its own
- K112805: Kimguard One-Step Sterilization Wrap (2012), 18 descendants of its own
- K112211: Dura Blue Sterilization Wrap (2011), 11 descendants of its own

## Recalls of this device
- Mar 6, 2013 · Class II · Z-0995-2013: Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

Source page: https://510kreport.com/device/K881471
Methodology: https://510kreport.com/methodology