510(k) · Cleared
ClearedKendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare · FRO Dressing, Wound, Drug
Cleared on Sep 12, 2007 as substantially equivalent to K990530 (The Kendall Company, L.P., 2000) after a 187-day review. Its family tree reaches back 2 generations to 1990. 7 later devices descend from it.
- Decided
- Sep 12, 2007
- Review
- 187 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895993 (1990). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK895993 Vitapatch Antimicrobial Catheter Securement DeviceVitaphore Corp. · 1990
- 1 generation backK990530 Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · Recalled
- This deviceK070653 Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use…Tyco Healthcare · 2007
- 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 |
|---|---|---|---|---|---|
| −2 | K895993 | Vitapatch Antimicrobial Catheter Securement Device | Vitaphore Corp. | 1990 | — |
| −1 | K990530 | Kerlix MD Antimicrobial Gauze Dressing | The Kendall Company, L.P. | 2000 | 7 |
| 0 (this device) | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K990530 | Kerlix MD Antimicrobial Gauze DressingSummary page 1…C use is substantially equivalent in intended use, function, and composition to Kendall's AMD Antimicrobial Gauze Dressing (Rx) cleared by FDA under 510(k) No. K990530. The primary purpose of this 510(k) is toallow OTC retail marketing of this dressing. Labeling of the OTC product has been a… | 2000 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K121522 (Polyremedy, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K990530.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Over the counter use as a primary or secondary dressing for light to moderate draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070653 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070653
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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