# K141712: Kimguard One Step Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health
- Decided: Dec 18, 2014 after 176 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). 5 ancestors in all.
5 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)
- K112805: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2012) Summary page 5.

## Most influential descendants
- K192147: Halyard ONE-STEP* Sterilization Wrap (2019), 4 descendants of its own
- K214007: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (2022), 3 descendants of its own
- K234050: HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (2024), 2 descendants of its own
- K261897: HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology (2026), 0 descendants of its own
- K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL  Sterilization Wrap; HALYARD* SMART-FOLD*  Sterilization Wrap (2026), 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: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer that include: Lumen Cycle and Non-Lumen Cycle. KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) 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 (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Non-Lumen Cycles). Additionally, the KIMGUARD ONE-STEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles. The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions: • An inside diameter of 1 mm or larger and a length of 60 mm or shorter; • An inside diameter of 2 mm or larger and a length of 250 mm or shorter; • An inside diameter of 3 mm or larger and a length of 350 mm or shorter. The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load). All models of the KIMGUARD ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles in Table 1. TABLE 1: Validated Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Cycle (Note: The instructions provided below are not intended to replace the detailed Instructions for Use provided with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer.) PSD-85 Cycle — Intended Loads Lumen: Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to 10 single channel stainless steel lumened devices of the following dimensions per chamber load: • An inside diameter of 1 mm or larger and a length of 60 mm or shorter • An inside diameter of 2 mm or larger and a length of 250 mm or shorter • An inside diameter of 3 mm or larger and a length of 350 mm or shorter (Refer to the PSD-85 User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 10 lbs per load) Non-Lumen: Non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors. (Refer to the PSD-85 User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lbs per load))

Source page: https://510kreport.com/device/K141712
Methodology: https://510kreport.com/methodology