510(k) · Cleared
ClearedDurablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization
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 Sep 26, 2012 as substantially equivalent to K112283 (Cardinal Health200, LLC, 2011) and 1 other predicate after a 40-day review. Its family tree reaches back 5 generations to 1988. 8 later devices descend from it.
- Decided
- Sep 26, 2012
- Review
- 40 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K881471 (1988). 8 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 4 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 3 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 2 generations backK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- 1 generation backK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- This deviceK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 4 of its ownK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- Descendant · 4 generations on · 3 of its ownK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
- Descendant · 5 generations on · 1 of its ownK233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123857Durablue Sterilization WrapCardinal Health200, LLC · 2013 · cites it directly7descendants
- K132060Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013 · 2 generations on5descendants
- K151788Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015 · 3 generations on4descendants
- K181174Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018 · 4 generations on3descendants
- K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −4 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −3 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −2 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| −1 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| 0 (this device) | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| +1 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| +2 | K132060 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
| +3 | K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015 | — |
| +4 | K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2018 | — |
| +5 | K233777 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K112283 | Dura Blue Sterilization WrapSummary page 1…lassification: Class 11per 21 CFR § 880.6850 Classification Name: Sterilization Wrap Predicate Device: K1 12283 - DuraBluew Sterilization Wrap - STERRAD 100S K120658 - DuraBlueTM Sterilization Wrap - STERRA… | 2011 |
| * | K120658 | Durablue Sterilization WrapSummary page 1…Sterilization Wrap Predicate Device: K1 12283 - DuraBluew Sterilization Wrap - STERRAD 100S K120658 - DuraBlueTM Sterilization Wrap - STERRAD 100S Description: Cardinal Health DuraBlue Sterilization Wraps are double layer sterili… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123857 | Durablue Sterilization Wrap | 2013 | 7 |
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 8 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K123857 (Cardinal Health200, LLC, 2013) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K112283.
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 Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:
* Standard and Advanced cycles of the STERRAD NX Sterilization System
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:
* 30 days following sterilization by STERRAD NX (Standard and Advanced cycles)
All models of DuraBlue Sterilization Wrap have been validated for use with the following STERRAD NX Sterilization Cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122507
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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