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 13, 2012 as substantially equivalent to K112211 (Cardinal Health200, LLC, 2011) and 2 other predicates after a 100-day review. Its family tree reaches back 4 generations to 1988. 9 later devices descend from it.
- Decided
- Jun 13, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K881471 (1988). 7 ancestors in all. 9 later devices descend from it, 3 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 backK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- This deviceK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- Descendant · cites it directly · 8 of its ownK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- Descendant · 2 generations on · 7 of its ownK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- Descendant · cites it directly · 5 of its ownK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- Descendant · 2 generations on · 4 of its ownK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122507Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…Cardinal Health200, LLC · 2012 · cites it directly8descendants
- K123857Durablue Sterilization WrapCardinal Health200, LLC · 2013 · 2 generations on7descendants
- K132060Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013 · cites it directly5descendants
- K151788Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015 · 2 generations on4descendants
- K181174Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018 · 3 generations on3descendants
View 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 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| 0 (this device) | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| +1 | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| +2 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| +1 | K132060 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
| +2 | K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015 | — |
| +3 | K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 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? (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 |
|---|---|---|---|
| * | K112211 | Dura Blue Sterilization WrapSummary page 1…"" Sterilization Wrap Classification: Class 11per 21 CFR § 880.6850 Classification Name: Sterilization Wrap Predicate Devices: K1 12211 - Duralue m Sterilization Wrap - Pre-Vacuum Steam (4 min/270*) K1… | 2011 |
| * | K112283 | Dura Blue Sterilization WrapSummary page 1…Predicate Devices: K1 12211 - Duralue m Sterilization Wrap - Pre-Vacuum Steam (4 min/270*) K1 12283 - DuraBlue m Sterilization Wrap - STERRAD 1IOOS K1 12918 - DuraBluet m Sterilization Wrap - Amsco… | 2011 |
| * | K112918 | Durablue Sterilization (Amsco V-Pro) WrapSummary page 1…eam (4 min/270*) K1 12283 - DuraBlue m Sterilization Wrap - STERRAD 1IOOS K1 12918 - DuraBluet m Sterilization Wrap - AmscoG V-PRO h 1 & 1 Plus (Lumen & Non Lumen Cycles) and Amsco… | 2012 |
What descends from it? (9)
3 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 24 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K122507 (Cardinal Health200, LLC, 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K112211.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 DuraBlue TM Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by the following modalities: * Pre-vacuum steam at 270 F/132 C for 4 minutes * STERRAD® 100S system. * 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…
Read the full statement (229 words)
Cardinal Health DuraBlue TM Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by the following modalities:
* Pre-vacuum steam at 270 F/132 C for 4 minutes
* STERRAD® 100S system.
* 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). Maintenance of package sterility was validated with real-time testing for the following durations:
* 180 days following sterilization by STERRAD 100S and Amsco V-PRO (Lumen, Non Lumen, and Flexible Cycles).
* 30 days following sterilization by pre-vacuum steam at 270 F/132 C for 4 minutes.
Cardinal Health DuraBlue Sterilization Wrap is not indicated for use with gravity steam sterilization.
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 lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120658: 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/K120658
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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