510(k) · Cleared
ClearedPoly Fit + Absorbing and High Absorbing Antimicrobial Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polyremedy, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 8, 2010 after a 247-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Apr 8, 2010
- Review
- 247 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK092351 Poly Fit + Absorbing and High Absorbing Antimicrobial DressingsPolyremedy, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK130857 Prontosan Wound Gel XB.Braun Medical, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK192527 Rochal Antimicrobial Wound GelRochal Industries, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK223259 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK241809 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · cites it directly5descendants
- K130857Prontosan Wound Gel XB.Braun Medical, Inc. · 2013 · 2 generations on3descendants
- K192527Rochal Antimicrobial Wound GelRochal Industries, LLC · 2020 · 3 generations on2descendants
- K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2023 · 3 generations on1descendant
- K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092351 | Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings | Polyremedy, Inc. | 2010 | — |
| +1 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| +2 | K130857 | Prontosan Wound Gel X | B.Braun Medical, Inc. | 2013 | — |
| +3 | K192527 | Rochal Antimicrobial Wound Gel | Rochal Industries, LLC | 2020 | — |
| +3 | K223259 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2023 | — |
| +4 | K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
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?
- Of its descendants, K121522 (Polyremedy, Inc., 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers (Stages II-IV), Lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, for 3rd degree burns or for dry wounds.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092351: Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092351
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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