510(k) · Cleared
ClearedMicrodacyn Hydrogel
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 Nov 8, 2024 as substantially equivalent to K093585 (Oculus Innovative Sciences, Inc., 2010) after a 260-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Nov 8, 2024
- Review
- 260 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K830708 (1983). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 4 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 3 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 2 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 1 generation backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- This deviceK240510 Microdacyn HydrogelSonoma Pharmaceuticals, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −4 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −3 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −2 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −1 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| 0 (this device) | K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K093585 | Microcyn Skin and Wound HydrogelSummary page 5…e: Dressing, wound, drug. Class: Unclassified. Product Code: FRO. 510(k) Review Panel: General & Plastic Surgery. III. PREDICATE DEVICE Microcyn Skin and Wound HydroGel (K093585) manufactured for Sonoma Pharmaceuticals. IV. DEVICE DESCRIPTION Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that cont… | 2010 |
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 41 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 4 other devices also cite its predicate K093585.
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?
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240510: Microdacyn Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240510
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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