510(k) · Cleared
ClearedMicrodacyn Wound Irrigation 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 Jun 24, 2026 as substantially equivalent to K233399 (Sonoma Pharmaceuticals, Inc., 2024) and 1 other predicate after an 86-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Jun 24, 2026
- Review
- 86 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K914579 (1992). 84 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 14 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 10 generations between
- 3 generations backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- 2 generations backK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- 1 generation backK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- This deviceK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 13 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 12 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 11 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 10 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 9 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 8 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 7 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 6 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 5 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 4 generations backK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- 3 generations backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- 2 generations backK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- 1 generation backK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- This deviceK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −13 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −12 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −11 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −10 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −9 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −8 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −7 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −6 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −5 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −4 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| −3 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| −2 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| −1 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 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 K243415 Granudacyn® Wound Irrigation Solutionscore 15.4 · 10 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 |
|---|---|---|---|
| * | K233399 | Microdacyn Wound Care SolutionSummary page 5…g. Class: Unclassified. Product Code: FRO 510(k) Review Panel: General & Plastic Surgery III. PREDICATE DEVICES Primary predicate device: Microdacyn Wound Care Solution (K233399) manufactured for Sonoma Pharmaceuticals, Inc. Secondary predicate device: Granudacyn® Wound Irrigation Solution (K243415) manufa… | 2024 |
| * | K243415 | Granudacyn® Wound Irrigation SolutionSummary page 5…edicate device: Microdacyn Wound Care Solution (K233399) manufactured for Sonoma Pharmaceuticals, Inc. Secondary predicate device: Granudacyn® Wound Irrigation Solution (K243415) manufactured for P.G.F. Industry Solutions GmbH. IV. DEVICE DESCRIPTION Microdacyn Wound Irrigation Solution (K261023) is a clea… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 84 ancestors have a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 for Use: Under the supervision of healthcare professionals, Microdacyn Wound Irrigation Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I–IV pressure ulcers, stasis ulcers, diabetic ulcers, post‑surgical wounds, first and partial thickness second degree burns…
Read the full statement (119 words)
Rx Indications for Use:
Under the supervision of healthcare professionals, Microdacyn Wound Irrigation Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I–IV pressure ulcers, stasis ulcers, diabetic ulcers, post‑surgical wounds, first and partial thickness second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
OTC Indications for Use:
Microdacyn Wound Irrigation 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/K261023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261023: Microdacyn Wound Irrigation Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261023
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026