510(k) · Cleared
ClearedMicrocyn Plus Wound Care Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences · FRO Dressing, Wound, Drug
Cleared on Aug 19, 2016 as substantially equivalent to K141012 (Oculus Innovative Sciences, 2014) and 1 other predicate after a 128-day review. Its family tree reaches back 11 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 19, 2016
- Review
- 128 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K914579 (1992). 60 ancestors in all, the oldest K830708 (1983). 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations between
- 3 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 2 generations backK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- 1 generation backK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- This deviceK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · cites it directly · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243875 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK172851 Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2017 · Recalled
Show all 11 generations
- Root · 11 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 10 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 9 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 8 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 7 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 6 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 5 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 4 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 3 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 2 generations backK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- 1 generation backK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- This deviceK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
Most influential descendants
Showing 3 of 3 · See all- K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · cites it directly1descendant
- K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025 · 2 generations on0descendants
- K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −10 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −9 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −8 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −7 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −6 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −5 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −4 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −3 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| −2 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| −1 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| 0 (this device) | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +1 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
| +2 | K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | 2025 | — |
| +1 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K141012 | Hydrocleanse Wound Care SolutionSummary page 4…Wound Cleanser Classification Name: Solution, Saline, Wound Dressing Regulatory Class: Unclassified Product Code: FRO III. PREDICATE DEVICE Oculus Hydrocleanse (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848). IV. DEVICE DESCRIPTION The Oculus Microcyn Plus Woun… | 2014 |
| * | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Summary page 4…ing Regulatory Class: Unclassified Product Code: FRO III. PREDICATE DEVICE Oculus Hydrocleanse (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848). IV. DEVICE DESCRIPTION The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear… | 2014 |
What descends from it? (3)
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 24 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 60 ancestors have a recall of any class.
- Of its descendants, K213514 (Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, abrasions, minor irritations of the skin, diabetic foot…
Read the full statement (110 words)
Rx Indications:
Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
Microcyn Plus is intended for use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161034: Microcyn Plus Wound Care Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161034
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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