510(k) · Cleared
ClearedCardinal Health 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 Dec 11, 2018 as substantially equivalent to K151445 (Cardinal Health200, LLC, 2015) and 2 other predicates after a 223-day review. Its family tree reaches back 9 generations to 1988. 3 later devices descend from it.
- Decided
- Dec 11, 2018
- Review
- 223 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K881471 (1988). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 5 generations between
- 3 generations backK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- 2 generations backK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- 1 generation backK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- This deviceK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
- Descendant · cites it directly · 1 of its ownK233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK222151 Sterilization WrapKenpax International Limited · 2023
Show all 9 generations
- Root · 9 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 8 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 7 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 6 generations backK112211 Dura Blue Sterilization WrapCardinal Health200, LLC · 2011
- 5 generations backK120658 Durablue Sterilization WrapCardinal Health200, LLC · 2012
- 4 generations backK122507 Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300…Cardinal Health200, LLC · 2012
- 3 generations backK123857 Durablue Sterilization WrapCardinal Health200, LLC · 2013
- 2 generations backK132060 Durablue Sterilization WrapCardinal Health-Medical Products and Services · 2013
- 1 generation backK151788 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2015
- This deviceK181174 Cardinal Health Sterilization WrapCardinal Health200, LLC · 2018
Most influential descendants
Showing 3 of 3 · See all- K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024 · cites it directly1descendant
- K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024 · 2 generations on0descendants
- K222151Sterilization WrapKenpax International Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −8 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −7 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −6 | K112211 | Dura Blue Sterilization Wrap | Cardinal Health200, LLC | 2011 | — |
| −5 | K120658 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2012 | — |
| −4 | K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500… | Cardinal Health200, LLC | 2012 | — |
| −3 | K123857 | Durablue Sterilization Wrap | Cardinal Health200, LLC | 2013 | — |
| −2 | K132060 | Durablue Sterilization Wrap | Cardinal Health-Medical Products and Services | 2013 | — |
| −1 | K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2015 | — |
| 0 (this device) | K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | 2018 | — |
| +1 | K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024 | — |
| +2 | K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024 | — |
| +1 | K222151 | Sterilization Wrap | Kenpax International Limited | 2023 | — |
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 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151445 | Cardinal Health Sterilization WrapSummary page 9…ation Wrap Common Name: Sterilization Wrap Product Code: FRG 510(k) number: K181174 Predicate Device: K151445, K151788, K161910 – Cardinal Health™ Sterilization Wrap for use with Pre-Vacuum Steam (4 min/270°F… | 2015 |
| * | K151788 | Cardinal Health Sterilization WrapSummary page 9…p Common Name: Sterilization Wrap Product Code: FRG 510(k) number: K181174 Predicate Device: K151445, K151788, K161910 – Cardinal Health™ Sterilization Wrap for use with Pre-Vacuum Steam (4 min/270°F), Gravit… | 2015 |
| * | K161910 | Cardinal Health Sterilization WrapSummary page 9…Name: Sterilization Wrap Product Code: FRG 510(k) number: K181174 Predicate Device: K151445, K151788, K161910 – Cardinal Health™ Sterilization Wrap for use with Pre-Vacuum Steam (4 min/270°F), Gravity… | 2017 |
What descends from it? (3)
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 30 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K233777 (Primed Medical Products, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151445.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • Gravity steam at 250°F/121°C for 30 minutes. • 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…
Read the full statement (445 words)
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Gravity steam at 250°F/121°C for 30 minutes.
• 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.
• Advanced Sterilization Products (ASP) STERRAD® 200 System.
• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.
• TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)
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 gravity steam sterilization and 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 the Cardinal Health™ 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 the Cardinal Health™ 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 the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.
All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 cycles in Tables 2 and 3. The Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 sterilization cycles.
All models of Cardinal Health™ Sterilization Wrap have been validated for use with the TSO3 STERIZONE® VP4 system with the intended loads as described in Table 4.
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/K181174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181174: Cardinal Health 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/K181174
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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