510(k) · Cleared

Cleared

Kimguard One Step Sterilization Wrap

K113806510(k) TraditionalCleared Aug 20, 2013606-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kimberly-Clark Health Care · FRG Wrap, Sterilization

Cleared on Aug 20, 2013 as substantially equivalent to K092167 (Kimberly-Clark Corp., 2009) after a 606-day review. Its family tree reaches back 3 generations to 1988. 9 later devices descend from it.

Decided: Aug 20, 2013
Review: 606 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K881471 (1988). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
2 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
1 generation backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
This deviceK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
Descendant · cites it directly · 7 of its ownK141612 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
Descendant · cites it directly · 6 of its ownK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
Descendant · 2 generations on · 2 of its ownK171533 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017
Descendant · 2 generations on · 1 of its ownK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
Descendant · 3 generations on · 0 of its ownK240438 CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ®…Comercializadora Brever · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all

K141612Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014 · cites it directly7descendants
K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016 · cites it directly6descendants
K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017 · 2 generations on2descendants
K182656JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019 · 2 generations on1descendant
K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K881471	Kimguard (Regular & Heavy Duty) Sterile Wrap	Kimberly-Clark Corp.	1988	1
−2	K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corp.	2009	—
−1	K092167	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400…	Kimberly-Clark Corp.	2009	—
0 (this device)	K113806	Kimguard One Step Sterilization Wrap	Kimberly-Clark Health Care	2013	—
+1	K141612	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	2014	—
+1	K160755	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Ahlstrom Nonwovens, LLC	2016	—
+2	K171533	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Ahlstrom Nonwovens, LLC	2017	—
+2	K182656	JAMBRO Single Core A Sterilization wrap	Jiangsu Zhande Medical Supplies Co., Ltd.	2019	—
+3	K240438	CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap…	Comercializadora Brever	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2016	1	0
2017	1	0
2019	1	0
2022	1	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K113806, 1988–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRG device

#1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K092167	Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 Summary page 1 …) 2. PREDICATE DEVICES KIMGUARD® ONE-STEP® Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation [510(k) Notification K092167, cleared November 2, 2009] 3. INDICATIONS FOR USE KIMGUARIJ 4 ONE-STEP4 Sterilization Wraps are intended…	Kimberly-Clark Corp.	2009	—

Also cleared against K092167: 6 other devices →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141612	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	2014	7
K160755	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Ahlstrom Nonwovens, LLC	2016	6
K140963	Kimguard Smart-Fold Sterilization Wrap	Kimberly-Clark Corp.	2014	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K141612 (Kimberly-Clark Health Care, 2014) has gone furthest, with 7 descendants of its own.
6 other devices also cite its predicate K092167.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007high 260 (2017) · low 110 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRG

2in 2022

2007high 29 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRG

18in 2025

2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	182	0	1
2008	2	—	0	2
2009	4	171	0	2
2010	4	213	0	0
2011	6	110	0	12
2012	10	133	0	4
2013	6	146	2	5
2014	8	177	0	13
2015	12	196	0	9
2016	9	131	0	20
2017	9	260	29	7
2018	5	150	0	22
2019	9	258	0	10
2020	5	122	14	21
2021	4	170	0	9
2022	9	217	2	4
2023	9	230	0	13
2024	11	182	0	21
2025	9	151	0	18
2026	4	247	0	—

What is it indicated for?

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 o 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…

Read the full statement (196 words)

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

o 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 (KC 100, KC200, 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]). (Refer to the STERRAD® Sterilizer System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

All models of the KIMGUARD® ONE-STEP® Sterilization Wrap 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113806: Kimguard One Step Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113806

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026