510(k) · Cleared
ClearedAtteris Antimicrobial Skin Protectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochal Industries, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 30, 2016 as substantially equivalent to K071371 (Tyco Healthcare Group LP, 2007) after a 155-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Sep 30, 2016
- Review
- 155 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071371 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071371 Copa Amd Antimicrobial Wound DressingTyco Healthcare Group LP · 2007
- This deviceK161212 Atteris Antimicrobial Skin ProtectantRochal Industries, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071371 | Copa Amd Antimicrobial Wound Dressing | Tyco Healthcare Group LP | 2007 | — |
| 0 (this device) | K161212 | Atteris Antimicrobial Skin Protectant | Rochal Industries, LLC | 2016 | — |
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 |
|---|---|---|---|
| * | K071371 | Copa Amd Antimicrobial Wound DressingSummary page 5…Dressing Gel Dressing K Number New K071371 K 121522 K140483 K130857 Class Unclassified… | 2007 |
| † | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | 2012 |
| † | K140483 | Asap Otc Wound Dressing Gel | 2014 |
| † | K130857 | Prontosan Wound Gel X | 2013 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K071371.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161212: Atteris Antimicrobial Skin Protectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161212
Report an extraction error
Are you the manufacturer?
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