510(k) · Cleared
ClearedKimguard One-Step Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Health Care · FRG Wrap, Sterilization
Cleared on Aug 7, 2014 as substantially equivalent to K113806 (Kimberly-Clark Health Care, 2013) after a 52-day review. Its family tree reaches back 4 generations to 1988. 7 later devices descend from it.
- Decided
- Aug 7, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881471 (1988). 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 3 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 2 generations backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 1 generation backK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- This deviceK141612 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
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −3 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −2 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| −1 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| 0 (this device) | 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 | — |
| +3 | K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K113806 | Kimguard One Step Sterilization WrapSummary page 7…ICES KIMGUARD® ONE-STEP® Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation [510(k) Notification K113806, cleared August 20, 2013] Special 510(k): Device Modification… | 2013 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | 2016 | 6 |
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 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160755 (Ahlstrom Nonwovens, LLC, 2016) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K113806.
How does its category compare?
All FRG devicesFRG 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 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 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…
Read the full statement (173 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
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 (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]).
The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) 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/K141612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141612: 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/K141612
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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