510(k) · Cleared
ClearedPolyfit Absorbing Antimicrobial Dressings (Otc)
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 Jun 27, 2012 as substantially equivalent to K092351 (Polyremedy, Inc., 2010) and 2 other predicates after a 35-day review. Its family tree reaches back 4 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 27, 2012
- Review
- 35 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914604 (1992). 11 ancestors in all, the oldest K895993 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- This deviceK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK130857 Prontosan Wound Gel XB.Braun Medical, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK192527 Rochal Antimicrobial Wound GelRochal Industries, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK223259 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK241809 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221532 PHMB Wound DressingWinner Medical Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K130857Prontosan Wound Gel XB.Braun Medical, Inc. · 2013 · cites it directly3descendants
- K192527Rochal Antimicrobial Wound GelRochal Industries, LLC · 2020 · 2 generations on2descendants
- K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2023 · 2 generations on1descendant
- K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2024 · 3 generations on0descendants
- K221532PHMB Wound DressingWinner Medical Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −3 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −2 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| 0 (this device) | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| +1 | K130857 | Prontosan Wound Gel X | B.Braun Medical, Inc. | 2013 | — |
| +2 | K192527 | Rochal Antimicrobial Wound Gel | Rochal Industries, LLC | 2020 | — |
| +2 | K223259 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2023 | — |
| +3 | K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2024 | — |
| +1 | K221532 | PHMB Wound Dressing | Winner Medical Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K092351 | Poly Fit + Absorbing and High Absorbing Antimicrobial DressingsSummary page 1…Unclassified (preamendment) PRODUCT CODE FRO PREDICATE DEVICES: Poly FIT'4+ High Absorbing Antimicrobial Dressings (K092351) Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) (K(070653)… | 2010 |
| * | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Summary page 1…crobial Dressings (K092351) Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) (K(070653) Convatec Aquacel Ag Hydrofiber Antimicrobial Dressings (KG80 383) Substa… | 2007 |
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 1…timicrobial Wound Dressing (K092351) and the Kendall Kerlix AMD Antimicrobial Wound Dressing (K(070653) and the Convatec Aquacel Ag Hydrofiber Antimicrobial Dressings (K(080383). Description of the Device Subject to Premarket Notification: PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dress… | 2008 |
What descends from it? (5)
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 20 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K130857 (B.Braun Medical, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K092351.
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?
For Over-the-Counter Use, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. Under the supervision of a healthcare professional, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for the management of: PolyFIT+ Absorbing Antimicrobial Dressings are intended as…
Read the full statement (137 words)
For Over-the-Counter Use, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Under the supervision of a healthcare professional, PolyFIT+ Absorbing Antimicrobial Dressings and PolyFIT+ High Absorbing Antimicrobial Dressings may be used for the management of:
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 as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers 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, or for 3rd degree burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121522: Polyfit Absorbing Antimicrobial Dressings (Otc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121522
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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