510(k) · Cleared
ClearedDura Blue 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 Oct 20, 2011 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1988. 11 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881471 (1988). 11 later devices descend from it, 2 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 deviceK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- Descendant · cites it directly · 9 of its ownK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- Descendant · 2 generations on · 8 of its ownK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- Descendant · cites it directly · 7 of its ownK123289 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- Descendant · 3 generations on · 7 of its ownK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- Descendant · 2 generations on · 5 of its ownK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120658Durablue Sterilization WrapCardinal Health200, LLC · 2012 · cites it directly9descendants
- K122507Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…Cardinal Health200, LLC · 2012 · 2 generations on8descendants
- K123289Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013 · cites it directly7descendants
- K123857Durablue Sterilization WrapCardinal Health200, LLC · 2013 · 3 generations on7descendants
- K132060Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013 · 2 generations on5descendants
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) | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| +1 | 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 | K123289 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
| +3 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| +2 | K132060 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K082177 | Kimguard One-Step Sterilization WrapSummary page 1…tion Wrap Classification: Class II per 21 CFR § 880.6850 Classification Name: Sterilization Wrap Predicate Device: K(082177 - KIMGUARD ONE-STEP Sterilization Wrap (Models KC100, KC200, KC400, KC500 and KC600)… | 2009 |
| * | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600Summary page 1…K(082177 - KIMGUARD ONE-STEP Sterilization Wrap (Models KC100, KC200, KC400, KC500 and KC600) K(091685 - KIMGUARD ONE-STEP Sterilization Wrap (Model 1(0300) Description: Cardinal Health DuraBluem Sterilization Wraps are double layer… | 2009 |
What descends from it? (11)
See all 112 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 23 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120658 (Cardinal Health200, LLC, 2012) has gone furthest, with 9 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. 2011, 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?
Cardinal Health Durasluem Sterilization Wrap is 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 F11 32C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CHiG00 and…
Read the full statement (126 words)
Cardinal Health Durasluem Sterilization Wrap is 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 F11 32C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CHiG00 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CHOOO. Models 0H400, CH500 and CH600 have been validated for sterilization of lumens of 3mm diameter or lamger and 400mm in length or less.
Cardinal Health DuraBluetm Sterilization Wrap is not indicated for use with gravity steam sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112211: Dura Blue 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/K112211
Report an extraction error
Are you the manufacturer?
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