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 Apr 3, 2015 as substantially equivalent to K082554 (Kimberly-Clark Corp., 2009) and 1 other predicate after a 162-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Apr 3, 2015
- Review
- 162 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K881471 (1988). 3 ancestors in all. 1 later device descends from it, 1 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 deviceK143053 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
- Descendant · cites it directly · 0 of its ownK233262 Dukal SMS Sterilization WrapDukal, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K233262Dukal SMS Sterilization WrapDukal, LLC · 2024 · cites it directly0descendants
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) | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 | — |
| +1 | K233262 | Dukal SMS Sterilization Wrap | Dukal, LLC | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600Summary page 5…ION: Class II per 21 CFR §880.6850 PREDICATE DEVICES: KIMGUARD* ONE-STEP* Sterilization Wrap, [510(k) Notification K082554 for ethylene oxide and K082177 for pre- vacuum steam, clearances on May 1, 2009 and March 27,… | 2009 |
| * | K082177 | Kimguard One-Step Sterilization WrapSummary page 5…R §880.6850 PREDICATE DEVICES: KIMGUARD* ONE-STEP* Sterilization Wrap, [510(k) Notification K082554 for ethylene oxide and K082177 for pre- vacuum steam, clearances on May 1, 2009 and March 27, 20… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233262 | Dukal SMS Sterilization Wrap | 2024 | 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 27 years and passes through 2 companies; a new generation was cleared every 20.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233262 (Dukal, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082554.
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 Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200. * 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for…
Read the full statement (177 words)
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
* Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.
* 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C for models KC100 and KC200.
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.
These models of the KIMGUARD* ONE-STEP* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143053: 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/K143053
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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