510(k) · Cleared
ClearedKendall Antimicrobial Drain 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 14, 2007 as substantially equivalent to K011941 (The Kendall Company, 2001) after a 186-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Sep 14, 2007
- Review
- 186 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914579 (1992). 10 ancestors in all, the oldest K820198 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK983833 Acticoat Composite Wound Dressing, Acticoat Composite Wound…Westaim Biomedical, Inc. · 1998
- 2 generations backK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- 1 generation backK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- This deviceK070685 Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | Westaim Biomedical, Inc. | 1998 | — |
| −2 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| −1 | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| 0 (this device) | K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K011941 | Excilon Amd Antimicrobial Sponge Model #7088Summary page 1…r OTC use is substantially equivalent in intended use, function, and composition to Kendall's Excilon AMD Antimicrobial Sponge (Rx) cleared by FDA under 510(k) No. K011941. The primary purpose of this 510(k) is to allow OTC retail marketing of this dressing. Labeling of the OTC product has been au… | 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 15 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
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 dressing around drains, IV sites, and tracheotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070685: Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070685
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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