# K140963: Kimguard Smart-Fold Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Nov 10, 2014 after 209 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112300: Kimguard Smart-Fold* Sterilization Wrap, Kimberly-Clark Corp. (2012) Summary page 6.
- K113806: Kimguard One Step Sterilization Wrap, Kimberly-Clark Health Care (2013) Summary page 6.

## Indications for use
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: Advanced Sterilization Products’ STERRAD® Sterilization Systems that include: STERRAD® 100S STERRAD® NX® [Standard Cycle, Advanced Cycle] STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] KIMGUARD* Smart Fold* Sterilization Wraps (KC450 and KC650) 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* Smart Fold* Sterilization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle], and 100NX®. [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]). (Refer to the STERRAD® Sterilization System User’s Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.) The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1. TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD® 100NX® Cycles ASP STERRAD® System and Cycle — Intended Load STERRAD® 100S: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens. STERRAD® NX® Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. STERRAD® NX® Advanced Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. OR One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. STERRAD® 100NX® Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.) STERRAD® 100NX® Flex Cycle: One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle). STERRAD® 100NX® EXPRESS Cycle: Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens. STERRAD® 100NX® DUO Cycle: One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter. Accessory devices that are normally connected to a flexible endoscope during use. Flexible endoscopes without lumens. KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2. TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with Advanced Sterilization Products (ASP) STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle, Advanced Cycle], and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]) KIMGUARD* Smart Fold* Sterilization Wrap Models — Intended Loads — Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study — Description of Loads Used in Sterility Maintenance Validation Study KC450 — Moderate to heavy weight package (e.g., general use medical instruments) — 10.7 lbs. — APTIMAX® Instrument Tray (23 in. x 11 in. x 4in.) with Tray Mat; Metal and non-metal instruments. KC650 — Very heavy weight package (e.g., general use medical instruments) — 10.7 lbs. — APTIMAX® Instrument Tray (23 in. x 11 in. x 4in.) with Tray Mat; Metal and non-metal instruments. Intended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, cameras, light cords, and general use medical instruments.

Source page: https://510kreport.com/device/K140963
Methodology: https://510kreport.com/methodology