510(k) Report

510(k) · Cleared

Cleared

Kimguard One-Step Sterilization Wrap

K141071510(k) TraditionalCleared Jul 28, 201494-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 Jul 28, 2014 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 1988. 7 later devices descend from it.

Decided
Jul 28, 2014
Review
94 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K881471 (1988). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant clearedK881471 · Kimguard (Regular & Heavy Duty) Sterile Wrap · Kimberly-Clark Corp. · 1988 · recalledK082177 · Kimguard One-Step Sterilization Wrap · Kimberly-Clark Corp. · 2009K091685 · Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 · Kimberly-Clark Corp. · 20091990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants K091685 · Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 · Kimberly-Clark Corp. · 2009K082177 · Kimguard One-Step Sterilization Wrap · Kimberly-Clark Corp. · 2009K881471 · Kimguard (Regular & Heavy Duty) Sterile Wrap · Kimberly-Clark Corp. · 1988 · recalled0
  1. Root · 3 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
  2. 2 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
  3. 1 generation backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
  4. This deviceK141071 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
  5. Descendant · cites it directly · 6 of its ownK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
  6. Descendant · 2 generations on · 2 of its ownK171533 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017
  7. Descendant · 2 generations on · 1 of its ownK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
  8. Descendant · 3 generations on · 0 of its ownK240438 CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ®…Comercializadora Brever · 2024
  9. Descendant · 3 generations on · 0 of its ownK230137 Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12019: 12022: 12023: 22024: 1
2016high 2 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all
  • 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
  • K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881471Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp.19881
−2K082177Kimguard One-Step Sterilization WrapKimberly-Clark Corp.2009—
−1K091685Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC…Kimberly-Clark Corp.2009—
0 (this device)K141071Kimguard One-Step Sterilization WrapKimberly-Clark Health Care2014—
+1K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC2016—
+2K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC2017—
+2K182656JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd.2019—
+3K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap…Comercializadora Brever2024—
+3K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201910
202210
202320
202410
FIG. 1 — Lineage of K141071, 1988–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082177Kimguard One-Step Sterilization Wrap
Summary page 1
…KC500, and KC600) 2. PREDICATE DEVICES KIMGUARD* ONE-STEP* Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation, ( K082177 and K09 1685). 3. INDICATIONS FOR USE KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600…
Kimberly-Clark Corp.2009—
*K091685Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600
Summary page 1
…KC600) 2. PREDICATE DEVICES KIMGUARD* ONE-STEP* Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation, ( K082177 and K09 1685). 3. INDICATIONS FOR USE KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intende…
Kimberly-Clark Corp.2009—

Also cleared against K082177: 8 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20166

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 26 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K160755 (Ahlstrom Nonwovens, LLC, 2016) has gone furthest, with 6 descendants of its own.
  • 8 other devices also cite its predicate K082177.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
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

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, K0200, 1(0300, 1(0400, KC0500 and 1(0600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using: *Gravity Steam at 250*F/121*O for 30 minutes. KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, 1(0200, 1(0300, 1(0400, 1(0500 and 1(0600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s)…

Read the full statement (114 words)

KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, K0200, 1(0300, 1(0400, KC0500 and 1(0600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

*Gravity Steam at 250*F/121*O for 30 minutes.

KIMGUARD* ONE-STEP* Sterilization Wrap (1(0100, 1(0200, 1(0300, 1(0400, 1(0500 and 1(0600) 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 t ONE-STEP* Sterilization Wrap (1(0100, 1(0200, 1(0300, 1(0400, KC0500 and 1(0600) allowed sterilization of the enclosed devices by the Gravity Steam Sterilization Systems (250*F/121*C for 30 minutes).

1(IMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use within Gravity Steam Systems are provided in Table 1.

Indications for use as stated in the FDA summary.

Also cleared against K082177

8 other devices cite the same predicate.

  • K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
  • K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
  • K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
  • K120542Cardinal Health Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2012
  • K112300Kimguard Smart-Fold* Sterilization WrapKimberly-Clark Corp. · 2012
  • K112211Dura Blue Sterilization WrapCardinal Health200, LLC · 2011

More from Kimberly-Clark Health Care

5 FDA decisions under this applicant name. See the company

  • K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
  • K142782KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
  • K141612Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
  • K113806Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K141071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141071: 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/K141071

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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