510(k) · Cleared
ClearedChlorashield TM Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion 213, LLC · FRO Dressing, Wound, Drug
Cleared on Mar 30, 2011 as substantially equivalent to K003229 (Integra Lifesciences Corp., 2001) and 1 other predicate after a 161-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Mar 30, 2011
- Review
- 161 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895920 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 2 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 1 generation backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- This deviceK103106 Chlorashield TM Antimicrobial DressingCare Fusion 213, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −2 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −1 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| 0 (this device) | K103106 | Chlorashield TM Antimicrobial Dressing | Care Fusion 213, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 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 |
|---|---|---|---|
| * | K003229 | Biopatch Antimicrobial DressingSummary page 4…Date of 510(k) # Clearance Company 1 K003229 10-26-2001 Integra Lifesciences… | 2001 |
| * | K063458 | 3M Tegaderm CHG DressingSummary page 4…229 10-26-2001 Integra Lifesciences 2 K063458 4-5-2007 3M Device Description: The ChloraShield™ Antimicrobial Dressing is intended to… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 7 other devices also cite its predicate K003229.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The ChloraShieldrTM Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103106: Chlorashield TM Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103106
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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