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 Jun 22, 2012 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) and 2 other predicates after a 269-day review. Its family tree reaches back 3 generations to 1988. 18 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881471 (1988). 4 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 2 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 1 generation backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- This deviceK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- Descendant · cites it directly · 6 of its ownK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
- Descendant · cites it directly · 5 of its ownK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
- Descendant · 2 generations on · 4 of its ownK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016 · cites it directly6descendants
- K141712Kimguard One Step Sterilization WrapHalyard Health · 2014 · cites it directly5descendants
- K192147Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019 · 2 generations on4descendants
- K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2022 · 3 generations on3descendants
- K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −2 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −1 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| 0 (this device) | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| +1 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2016 | — |
| +1 | K141712 | Kimguard One Step Sterilization Wrap | Halyard Health | 2014 | — |
| +2 | K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019 | — |
| +3 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2022 | — |
| +4 | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization… | O&M Halyard, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (3)
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 2…ss. Substantial Equivalence: KIMIGUARD ONE-STEP* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE- STEP* Sterilization Wrap (K082177,K091 685, and K0921 67) in intended use, design, and materials. Summary of Testing: KIMGUARD ONE-STEW* Sterilization Wrap was pr… | 2009 |
| * | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600Summary page 2…stantial Equivalence: KIMIGUARD ONE-STEP* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE- STEP* Sterilization Wrap (K082177,K091 685, and K0921 67) in intended use, design, and materials. Summary of Testing: KIMGUARD ONE-STEW* Sterilization Wrap was previously… | 2009 |
| * | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600Summary page 2…alence: KIMIGUARD ONE-STEP* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE- STEP* Sterilization Wrap (K082177,K091 685, and K0921 67) in intended use, design, and materials. Summary of Testing: KIMGUARD ONE-STEW* Sterilization Wrap was previously tested in comp… | 2009 |
| † | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | 2011 |
What descends from it? (18)
See all 184 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 24 years and passes through 1 company; a new generation was cleared every 2.8 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.
- 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. 2012, 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 be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F/1 3200 for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mgIL at 131 0F/55 0 0 and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco@ V-PROM 1 Low Temperature Sterilization…
Read the full statement (244 words)
KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F/1 3200 for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mgIL at 131 0F/55 0 0 and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco@ V-PROM 1 Low Temperature Sterilization System's cycle, the Amsco@ V-PROM 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cycle) and Non Lumen Cycles, and the V-PROTM Low Temperature Sterilization System's Flexible Cycle. 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 within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55COC or 12 hours at 43.3 0C. The KIMGUARD ONE-STEP* Sterilization Wrap were validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP t Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO , V-Pp 0 TM 1 Plus, and the V-PROTM Flexible Sterilization Cycles.
KIMGUARD ONE-STEP t Sterilization Wraps are not indicated for use for gravity steam sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112805: 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/K112805
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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