510(k) · Cleared
Recalled · 2011Microcyn Wound Care Dressing
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 3, 2005 after a 365-day review. The FDA summary names its predicate without a number. 1 of the 42 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it. It has been recalled 2 times.
- Decided
- May 3, 2005
- Review
- 365 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 2
- Predicates
- 0
41 later devices descend from it, 5 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- This deviceK041161 Microcyn Wound Care DressingOculus Innovative Sciences, Inc. · 2005
- Descendant · cites it directly · 22 of its ownK070463 Revera Wound Care, Model MDW0060Revalesio Corporation · 2008
- Descendant · cites it directly · 20 of its ownK093697 Vashe Wound Therapy SolutionPuricore, Inc. · 2010
- Descendant · cites it directly · 16 of its ownK092232 Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc. · 2009
- Descendant · 2 generations on · 15 of its ownK113693 Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012
- Descendant · 2 generations on · 14 of its ownK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
Showing 5 of 41 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 41 · See all- K070463Revera Wound Care, Model MDW0060Revalesio Corporation · 2008 · cites it directly22descendants
- K093697Vashe Wound Therapy SolutionPuricore, Inc. · 2010 · cites it directly20descendants
- K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc. · 2009 · cites it directly16descendants
- K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012 · 2 generations on15descendants
- K133542Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041161 | Microcyn Wound Care Dressing | Oculus Innovative Sciences, Inc. | 2005 | — |
| +1 | K070463 | Revera Wound Care, Model MDW0060 | Revalesio Corporation | 2008 | — |
| +1 | K093697 | Vashe Wound Therapy Solution | Puricore, Inc. | 2010 | — |
| +1 | K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | Puricore, Inc. | 2009 | — |
| +2 | K113693 | Nixall TM Wound and Skin Care | Seriously Clean, Ltd. | 2012 | — |
| +2 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | — | Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride Named without a submission number |
What descends from it? (41)
See all 415 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2011 | Not classified | Z-0448-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
| Nov 9, 2011 | Not classified | Z-0450-2012 | Process control | Unapproved drug claims and those not approved under 510K clearance. |
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?
- Of its descendants, K070463 (Revalesio Corporation, 2008) has gone furthest, with 22 descendants 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.
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 Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.
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/K041161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041161: Microcyn Wound Care Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041161
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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