510(k) · Cleared
ClearedDurablue Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · FRG Wrap, Sterilization
Cleared on Jun 18, 2013 as substantially equivalent to K123857 (Cardinal Health200, LLC, 2013) and 2 other predicates after a 76-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jun 18, 2013
- Review
- 76 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K881471 (1988). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 6 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 5 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 4 generations backK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- 3 generations backK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- 2 generations backK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- 1 generation backK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- This deviceK130927 Durablue Sterilization WrapCardinal Health200, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −6 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −5 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −4 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| −3 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| −2 | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| −1 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| 0 (this device) | K130927 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
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 |
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 |
|---|---|---|---|
| * | K123857 | Durablue Sterilization WrapSummary page 1…egan, IL 60085 (847) 887-3323 (847) 887-2461 June 14, 2013 DuraBlue ™ Sterilization Wrap Class Ii per 21. CFR § 880.6850 Sterilization Wrap Sterilization Wrap FRG K123857 — DuraBlue™ Sterilization Wrap — Johnson & Johnson STERRAD® NX and STERRAD® 100NX K123289 - DuraBlue™ Sterilization Wrap ~ Pre-V… | 2013 |
| * | K123289 | Durablue Sterilization WrapSummary page 1…p Class Ii per 21. CFR § 880.6850 Sterilization Wrap Sterilization Wrap FRG K123857 — DuraBlue™ Sterilization Wrap — Johnson & Johnson STERRAD® NX and STERRAD® 100NX K123289 - DuraBlue™ Sterilization Wrap ~ Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO) K120658 — DuraBlue™ Sterilization Wra… | 2013 |
| * | K120658 | Durablue Sterilization WrapSummary page 1…terilization Wrap — Johnson & Johnson STERRAD® NX and STERRAD® 100NX K123289 - DuraBlue™ Sterilization Wrap ~ Pre-Vacuum Steam (4 min/270°F) & 100% Ethylene Oxide (EO) K120658 — DuraBlue™ Sterilization Wrap — STERRAD® 100S and Amsco® V-PRO™ 1. Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ MAX Low Temperature S… | 2012 |
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 25 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K123857.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: Pre-vacuum steam at 270°F/132°C for 4 minutes 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 Advanced Sterilization Products (ASP) STERRAD® 100S system. Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles…
Read the full statement (326 words)
DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
Pre-vacuum steam at 270°F/132°C for 4 minutes
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
Advanced Sterilization Products (ASP) STERRAD® 100S system.
Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles
Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.
For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 °C. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.
All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.
All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.
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/K130927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130927: Durablue 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/K130927
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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