510(k) Report

510(k) · Cleared

Cleared

Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600

K082554510(k) TraditionalCleared May 1, 2009240-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 Corp. · FRG Wrap, Sterilization

Cleared on May 1, 2009 as substantially equivalent to K881471 (Kimberly-Clark Corp., 1988) after a 240-day review. Its family tree reaches back 1 generation to 1988. 10 later devices descend from it.

Decided
May 1, 2009
Review
240 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K881471 (1988). 10 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2022: 2 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant clearedK881471 · Kimguard (Regular & Heavy Duty) Sterile Wrap · Kimberly-Clark Corp. · 1988 · recalled1990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K881471 · Kimguard (Regular & Heavy Duty) Sterile Wrap · Kimberly-Clark Corp. · 1988 · recalled0
  1. Root · 1 generation backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
  2. This deviceK082554 Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400…Kimberly-Clark Corp. · 2009
  3. Descendant · cites it directly · 6 of its ownK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
  4. Descendant · 2 generations on · 2 of its ownK171533 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017
  5. Descendant · 2 generations on · 1 of its ownK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
  6. Descendant · cites it directly · 1 of its ownK143053 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
  7. Descendant · 3 generations on · 0 of its ownK240438 CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ®…Comercializadora Brever · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 12019: 12022: 22023: 22024: 2
2015high 2 (2022) · low 0 (2018)2026

Most influential descendants

Showing 5 of 10 · 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
  • K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K881471Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp.19881
0 (this device)K082554Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600Kimberly-Clark Corp.2009—
+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—
+1K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care2015—
+3K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap…Comercializadora Brever2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201710
201910
202220
202320
202420
FIG. 1 — Lineage of K082554, 1988–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K881471Kimguard (Regular & Heavy Duty) Sterile Wrap
Summary page 2
…predicate KIMGUARD* Regular and Heavy Duty Sterile Wraps Page 1 of 3 - 510(k) Summary (K881471) Substantial The KIMGUARD* Sterilization Wrap is substantially equivalent to the Equivalence: predicates in intended use, d…
Kimberly-Clark Corp.19881

Also cleared against K881471: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20166
K143053KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care20151
K233262Dukal SMS Sterilization WrapDukal, LLC20240
K213907CareGUARD Sterilization WrapCare Essentials Pty, Ltd.20220

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?

  • Its one ancestor has a recall.
  • Of its descendants, K160755 (Ahlstrom Nonwovens, LLC, 2016) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K881471.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270-F/1 32-C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55-C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s)…

Read the full statement (153 words)

KIMGUARD* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270-F/1 32-C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55-C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EtO sterilization of 8 hours at 55 QC or 12 hours at 43.3 QC. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500., and 600.

KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.

See Wrap Model Recommendations on Page 2.

Indications for use as stated in the FDA summary.

Also cleared against K881471

1 other device cites the same predicate.

  • K082177Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009

More from Kimberly-Clark Corp.

104 FDA decisions under this applicant name. See the company

  • K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014
  • K141294U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014
  • K131879KC 300 Surgical MaskKimberly-Clark Corp. · 20131 recall
  • K131841Kimberly-Clark Lavender Nitrile Powder-Free Exam GloveKimberly-Clark Corp. · 2013
  • K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 20135 Class I recalls

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/K082554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082554: Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082554

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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