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 Mar 9, 2015 as substantially equivalent to K092167 (Kimberly-Clark Corp., 2009) and 1 other predicate after a 164-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- Mar 9, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881471 (1988). 5 ancestors in all. 2 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 backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 1 generation backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- This deviceK142782 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
- Descendant · cites it directly · 1 of its ownK181959 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Owens & Minor Halyard, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK240330 HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD*…O&M Halyard, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | 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 | — |
| 0 (this device) | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 | — |
| +1 | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | 2019 | — |
| +2 | K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD*… | 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 |
|---|---|---|
| 2019 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600Summary page 5…Sterilization Wrap PRODUCT CODE: FRG DEVICE CLASSIFICATION: Class II per 21 CFR §880.6850 PREDICATE DEVICES: K092167 and K112805 - KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500… | 2009 |
| * | K112805 | Kimguard One-Step Sterilization WrapSummary page 5…terilization Wrap PRODUCT CODE: FRG DEVICE CLASSIFICATION: Class II per 21 CFR §880.6850 PREDICATE DEVICES: K092167 and K112805 - KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | 2019 | 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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K181959 (Owens & Minor Halyard, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K092167.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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: V-PRO® 60 Low Temperature Sterilization System that include: Lumen Cycle Non Lumen Cycle Flexible Cycle KIMGUARD® ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s)…
Read the full statement (179 words)
KIMGUARD® ONE-STEP Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
V-PRO® 60 Low Temperature Sterilization System that include:
Lumen Cycle
Non Lumen Cycle
Flexible Cycle
KIMGUARD® ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) 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 (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD® ONE-STEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles. All models of the KIMGUARD® ONE-STEP Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in TABLE 1.
KIMGUARD ONE-STEP Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in Table 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142782: 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/K142782
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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