510(k) · Cleared
ClearedDermacyn Wound Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 22, 2006 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 1 other predicate after a 36-day review. Its family tree reaches back 3 generations to 1995. 1 of the 57 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it.
- Decided
- Feb 22, 2006
- Review
- 36 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945802 (1995). 4 ancestors in all. 52 later devices descend from it, 3 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 2 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 1 generation backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- This deviceK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- Descendant · cites it directly · 29 of its ownK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- Descendant · 2 generations on · 22 of its ownK090141 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2009
- Descendant · 3 generations on · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK071056 Neutrophase Wound CleanserNovabay Pharmaceuticals · 2007
- Descendant · 2 generations on · 16 of its ownK081009 NeutrophaseNovabay Pharmaceuticals · 2008
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Salinecites it directly · 2008
Most influential descendants
Showing 5 of 52 · See all- K072876Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008 · cites it directly29descendants
- K090141Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2009 · 2 generations on22descendants
- K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · 3 generations on21descendants
- K071056Neutrophase Wound CleanserNovabay Pharmaceuticals · 2007 · cites it directly17descendants
- K081009NeutrophaseNovabay Pharmaceuticals · 2008 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −2 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −1 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| 0 (this device) | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| +1 | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| +2 | K090141 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2009 | — |
| +3 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| +1 | K071056 | Neutrophase Wound Cleanser | Novabay Pharmaceuticals | 2007 | — |
| +2 | K081009 | Neutrophase | Novabay Pharmaceuticals | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K965120 | Allclenz Wound CleanserSummary page 1…nuary 13, 2006 Trade Name Dermacyn™ Wound Care Common Name Wound Cleanser Classification Name Liquid Bandage Predicate Device Allclenz™ Cleanser; Healthpoint Medical K965120, Mar. 21%, 1997 CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct. 17", 2002 Description The subject device… | 1997 |
| * | K022670 | Carraklenz and UltraklenzSummary page 1…fication Name Liquid Bandage Predicate Device Allclenz™ Cleanser; Healthpoint Medical K965120, Mar. 21%, 1997 CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct. 17", 2002 Description The subject device is a wound cleansing solution that is intended for the moistening and debriding… | 2002 |
What descends from it? (52)
See all 523 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072876 (B.Braun Medical, Inc., 2008) has gone furthest, with 29 descendants of its own.
- 7 other devices also cite its predicate K965120.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060113: Dermacyn Wound Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060113
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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