510(k) · Cleared
ClearedCHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial Foam Patch, CHG Patch, CHG Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products, Ltd. · FRO Dressing, Wound, Drug
Cleared on Oct 26, 2012 as substantially equivalent to K003229 (Integra Lifesciences Corp., 2001) after a 213-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Oct 26, 2012
- Review
- 213 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895920 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 1 generation backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- This deviceK120930 CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG…Medtrade Products, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −1 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| 0 (this device) | K120930 | CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial… | Medtrade Products, Ltd. | 2012 | — |
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? (1)
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 1…g Classification:- Unclassified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- BIOPATCH, 51 0(k) # K003229, manufactured by Johnson and Johnson Wound Management. Device Description:- The Medtrade Product Ltd CHG Antibacterial Foam Pat… | 2001 |
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 21 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
- 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. 2012, 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?
Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as:
A hydrophilic foam patch that is used to absorb exudates and to cover the peni-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120930: CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial Foam Patch, CHG Patch, CHG Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120930
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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