510(k) · Cleared
ClearedDermacyn Wound Irrigation
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 May 17, 2005 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 1 other predicate after a 228-day review. Its family tree reaches back 3 generations to 1995. 1 of the 94 devices in its family, counting itself, has a Class I recall. 89 later devices descend from it.
- Decided
- May 17, 2005
- Review
- 228 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. 89 later devices descend from it, 11 citing it directly. 1 of the 94 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 deviceK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
- Descendant · cites it directly · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · cites it directly · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 2 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 3 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Saline2 generations on · 2008
Most influential descendants
Showing 5 of 89 · See all- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · cites it directly66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 2 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 2 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 3 generations on25descendants
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) | K042729 | Dermacyn Wound Irrigation | Oculus Innovative Sciences, Inc. | 2005 | — |
| +1 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +1 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +2 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +2 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +3 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 1 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 11 | 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…und Cleanser Classification Name Solution, saline (wound dressing) Predicate Device AllclenzTM Cleanser; Healthpoint Medical K965120, Mar. 21st, 1997 CarraKlenz Wound Cleanser; Carrington Laboratories, Inc.… | 1997 |
| * | K022670 | Carraklenz and UltraklenzSummary page 1…dical K965120, Mar. 21st, 1997 CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct. 17tb, 2002 Description The subject device is a wound cleansing solution that is intended for… | 2002 |
What descends from it? (89)
See all 8911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063069 | Silvaklenz Skin and Wound Clenser Solution | 2007 | 73 |
| K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel | 2008 | 66 |
| K070463 | Revera Wound Care, Model MDW0060 | 2008 | 22 |
| K071056 | Neutrophase Wound Cleanser | 2007 | 17 |
| K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | 2009 | 16 |
| K063063 | Silvacide Skin & Wound Moisturizing Solution | 2007 | 14 |
| K061467 | Exsept WC Wound Cleanser | 2007 | 11 |
| K090791 | Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5% | 2009 | 10 |
| K111313 | Exsept Skin and Wound Cleanser with Antimicrobial Preservative | 2011 | 9 |
| K082858 | Exsept WC Antimicrobial Skin and Wound Cleanser | 2009 | 0 |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063069 (Medical Molecular Therapuetics, LLC, 2007) has gone furthest, with 73 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 Wound Cleanser is intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, 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/K042729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042729: Dermacyn Wound Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042729
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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