510(k) · Cleared
ClearedSterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenpax International Limited · FRG Wrap, Sterilization
Cleared on Mar 23, 2023 as substantially equivalent to K181174 (Cardinal Health200, LLC, 2018) after a 246-day review. Its family tree reaches back 10 generations to 1988.
- Decided
- Mar 23, 2023
- Review
- 246 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K881471 (1988). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 6 generations between
- 3 generations backK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- 2 generations backK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- 1 generation backK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
- This deviceK222151 Sterilization WrapKenpax International Limited · 2023
Show all 10 generations
- Root · 10 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 9 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 8 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 7 generations backK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- 6 generations backK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- 5 generations backK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- 4 generations backK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- 3 generations backK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- 2 generations backK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- 1 generation backK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
- This deviceK222151 Sterilization WrapKenpax International Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −9 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −8 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −7 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| −6 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| −5 | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| −4 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| −3 | K132060 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
| −2 | K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015 | — |
| −1 | K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2018 | — |
| 0 (this device) | K222151 | Sterilization Wrap | Kenpax International Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K181174 | Cardinal Health Sterilization WrapSummary page 8…Page 4 of 15 510(k) Summary 6. Identification of Predicate Device(s) Primary Predicate Device 510(k) Number: K181174 Product Name: Cardinal Health TM Sterilization Wrap Manufacturer: Cardinal Health 200 LLC Classification: 2 Produ… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K181174.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization. Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: a) 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. b) Exhausting the EO…
Read the full statement (126 words)
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization.
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
a) 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.
b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar
c) Aeration time : 12 hours
d) Aeration temperature: 55°C
e) Aeration pressure : 841 mBar to 864 mBar
Suggestions for the packaging content are given in table, A single layer of wrapping needs to be packaged in two sheets.
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/K222151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222151: 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/K222151
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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