510(k) · Cleared
ClearedKimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, 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 Sep 3, 2009 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) after an 85-day review. Its family tree reaches back 2 generations to 1988. 32 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 85 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881471 (1988). 32 later devices descend from it, 4 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 deviceK091685 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 · 11 of its ownK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- Descendant · 2 generations on · 9 of its ownK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- Descendant · 3 generations on · 8 of its ownK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- Descendant · cites it directly · 7 of its ownK141071 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012 · cites it directly18descendants
- K112211Dura Blue Sterilization WrapCardinal Health200, LLC · 2011 · cites it directly11descendants
- K120658Durablue Sterilization WrapCardinal Health200, LLC · 2012 · 2 generations on9descendants
- K122507Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…Cardinal Health200, LLC · 2012 · 3 generations on8descendants
- K141071Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014 · cites it directly7descendants
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) | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| +1 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| +1 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| +2 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| +3 | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| +1 | K141071 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Health Care | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 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…gravity steam sterilizeation. The KC 300 Model KIMGUARD ONE STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene. oxide sterilization method of 100% ethylene oxide. (EtO) with a0concentration… | 2009 |
What descends from it? (32)
See all 324 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
The KC300 Model KIMGUARD ONE-STEP* 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 0C for 4 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 KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization…
Read the full statement (151 words)
The KC300 Model KIMGUARD ONE-STEP* 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 0C for 4 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 KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization of 30 minutes.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The KC 300 Model KIMGUARD ONE-STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene oxide sterilization method of 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55 0C and 40% - 80% relative humidity for 60 minutes.
See KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for pre-vacuum steam on Page 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091685
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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