510(k) · Cleared
ClearedKimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · FRG Wrap, Sterilization
Cleared on Nov 2, 2009 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) after a 104-day review. Its family tree reaches back 2 generations to 1988. 35 later devices descend from it.
- Decided
- Nov 2, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881471 (1988). 35 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 1 generation backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- This deviceK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- Descendant · cites it directly · 18 of its ownK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- Descendant · cites it directly · 10 of its ownK112918 Durablue Sterilization (Amsco V-Pro) WrapCardinal Health200, LLC · 2012
- Descendant · cites it directly · 10 of its ownK112283 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- Descendant · cites it directly · 9 of its ownK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- Descendant · 2 generations on · 9 of its ownK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012 · cites it directly18descendants
- K112918Durablue Sterilization (Amsco V-Pro) WrapCardinal Health200, LLC · 2012 · cites it directly10descendants
- K112283Dura Blue Sterilization WrapCardinal Health200, LLC · 2011 · cites it directly10descendants
- K113806Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013 · cites it directly9descendants
- K120658Durablue Sterilization WrapCardinal Health200, LLC · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −1 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| 0 (this device) | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| +1 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| +1 | K112918 | Durablue Sterilization (Amsco V-Pro) Wrap | Cardinal Health200, LLC | 2012 | — |
| +1 | K112283 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| +1 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| +2 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K082177 | Kimguard One-Step Sterilization WrapSummary page 1…tially equivalent to the predicate KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) (K082177). Substantial The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the Equivalence: predicate in intended… | 2009 |
What descends from it? (35)
See all 357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112805 | Kimguard One-Step Sterilization Wrap | 2012 | 18 |
| K112918 | Durablue Sterilization (Amsco V-Pro) Wrap | 2012 | 10 |
| K112283 | Dura Blue Sterilization Wrap | 2011 | 10 |
| K113806 | Kimguard One Step Sterilization Wrap | 2013 | 9 |
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | 2016 | 6 |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | 2015 | 2 |
| K110954 | Arjorad Sterile Wrap | 2012 | 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 21 years and passes through 1 company; a new generation was cleared every 20.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K112805 (Kimberly-Clark Corp., 2012) has gone furthest, with 18 descendants of its own.
- 8 other devices also cite its predicate K082177.
How does its category compare?
All FRG devicesFRG 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
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 Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the…
Read the full statement (121 words)
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. 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 to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.
KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are provided on Page 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092167
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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