510(k) · Cleared
ClearedDurablue Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health-Medical Products and Services · FRG Wrap, Sterilization
Cleared on Feb 28, 2013 as substantially equivalent to K112211 (Cardinal Health200, LLC, 2011) and 1 other predicate after a 129-day review. Its family tree reaches back 4 generations to 1988. 7 later devices descend from it.
- Decided
- Feb 28, 2013
- Review
- 129 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881471 (1988). 5 ancestors in all. 7 later devices descend from it, 2 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 deviceK123289 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 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
- Descendant · 4 generations on · 1 of its ownK233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024 · 4 generations on1descendant
- K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024 · 5 generations on0descendants
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) | K123289 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 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 | — |
| +4 | K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024 | — |
| +5 | K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K112211 | Dura Blue Sterilization WrapSummary page 1…ame: Sterilization Wrap Common Name: Sterilization Wrap Product Code: FRG Predicate Device: K1 12211 - DuraBluemn Sterilization Wrap - Pre-vacuum Steam (4 minI27O 0C)… | 2011 |
| * | K120542 | Cardinal Health Durablue Sterilization WrapSummary page 1…ice: K1 12211 - DuraBluemn Sterilization Wrap - Pre-vacuum Steam (4 minI27O 0C) K120542 - DuraBlue'M Sterilization Wrap - Ethylene Oxide(EO) (725- 735 mg/L at 55OC40%-80%RH6O min)… | 2012 |
What descends from it? (7)
2 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 25 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K132060 (Cardinal Health-Medical Products and Services, 2013) has gone furthest, with 5 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. 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?
Cardinal Health DuraBlue Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using the following modalities: * 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 The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the…
Read the full statement (198 words)
Cardinal Health DuraBlue Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using the following modalities:
* 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
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 aging testing for a duration of 180 days for each indicated modality.
For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 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 sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123289: 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/K123289
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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