510(k) · Cleared
ClearedMicrodacyn Wound Care Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Pharmaceuticals, Inc. · FRO Dressing, Wound, Drug
Cleared on Sep 13, 2024 as substantially equivalent to K172622 (Sonoma Pharmaceuticals, 2017) and 1 other predicate after a 345-day review. Its family tree reaches back 13 generations to 1992. 1 later device descends from it.
- Decided
- Sep 13, 2024
- Review
- 345 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K914579 (1992). 65 ancestors in all, the oldest K830708 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations between
- 3 generations backK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- 2 generations backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- 1 generation backK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- This deviceK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 12 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 11 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 10 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 9 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 8 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 7 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 6 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 5 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 4 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 3 generations backK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- 2 generations backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- 1 generation backK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- This deviceK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −12 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −11 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −10 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −9 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −8 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −7 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −6 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −5 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −4 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −3 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| −2 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| −1 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| 0 (this device) | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| +1 | K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K172622 | Microcyn Antimicrobial Skin and Wound CleanserSummary page 5…sified. Product Code: FRO 510(k) Review Panel: General & Plastic Surgery III. PREDICATE DEVICES Primary Predicate Device: Microcyn Antimicrobial Skin and Wound Cleanser (K172622) manufactured for Sonoma Pharmaceuticals. Secondary Predicate Device: Simple Science Antimicrobial Facial and Eyelid Cleanser (K1… | 2017 |
| * | K181074 | Simple Science Antimicrobial Facial and Eyelid CleanserSummary page 5…microbial Skin and Wound Cleanser (K172622) manufactured for Sonoma Pharmaceuticals. Secondary Predicate Device: Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074) manufactured for Simple Science LLC. IV. DEVICE DESCRIPTION Microdacyn Wound Care Solution is a clear solution that aids in the… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | 2026 | 0 |
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 32 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 65 ancestors have a recall of any class.
- Of its descendants, K261023 (Sonoma Pharmaceuticals, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172622.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Under the supervision of a healthcare professional, Microdacyn Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material 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 burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails…
Read the full statement (113 words)
Under the supervision of a healthcare professional, Microdacyn Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material 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 burns, 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.
Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233399: Microdacyn Wound Care Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233399
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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