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 Corp. · FRG Wrap, Sterilization
Cleared on Mar 27, 2009 as substantially equivalent to K881471 (Kimberly-Clark Corp., 1988) after a 238-day review. Its family tree reaches back 1 generation to 1988. 44 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 238 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881471 (1988). 44 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- This deviceK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- Descendant · cites it directly · 35 of its ownK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- Descendant · cites it directly · 32 of its ownK091685 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 · 10 of its ownK112918 Durablue Sterilization (Amsco V-Pro) WrapCardinal Health200, LLC · 2012
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K092167Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600Kimberly-Clark Corp. · 2009 · cites it directly35descendants
- K091685Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600Kimberly-Clark Corp. · 2009 · cites it directly32descendants
- K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012 · cites it directly18descendants
- K112211Dura Blue Sterilization WrapCardinal Health200, LLC · 2011 · cites it directly11descendants
- K112918Durablue Sterilization (Amsco V-Pro) WrapCardinal Health200, LLC · 2012 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| 0 (this device) | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| +1 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| +1 | 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 | K112918 | Durablue Sterilization (Amsco V-Pro) Wrap | Cardinal Health200, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 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 |
|---|---|---|---|
| * | K881471 | Kimguard (Regular & Heavy Duty) Sterile WrapSummary page 2…KC100, KC200, KC300, KC400, KC500, and KC600) are substantially equivalent to the predicate KIMGUARD* Regular and Heavy Duty Sterile Wraps (K881471) Substantial The KIMGUARD ONE-STEP* Sterilization Wrap is substantially Equivalence: equivalent to the predicates in intend… | 1988 |
What descends from it? (44)
See all 449 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 | 2009 | 35 |
| K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 | 2009 | 32 |
| K112805 | Kimguard One-Step Sterilization Wrap | 2012 | 18 |
| K112211 | Dura Blue Sterilization Wrap | 2011 | 11 |
| K120542 | Cardinal Health Durablue Sterilization Wrap | 2012 | 8 |
| K141071 | Kimguard One-Step Sterilization Wrap | 2014 | 7 |
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | 2016 | 6 |
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | 2015 | 1 |
| K112300 | Kimguard Smart-Fold* Sterilization Wrap | 2012 | 1 |
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?
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 health care provider by pre-vacuum steam at 270°F/132 0C for 4 minutes or by.100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131 F/ 550C 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…
Read the full statement (167 words)
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/132 0C for 4 minutes or by.100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131 F/ 550C 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 EO sterilization of 8 hours at 55 0C or 12 hours at 43.3 0C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
*The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.
See Wrap Model Recommendations on Page 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082177: Kimguard One-Step Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082177
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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