510(k) · Cleared
ClearedHydrocleanse Antimicrobial Skin and Wound Care Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Pharmaceuticals · FRO Dressing, Wound, Drug
Cleared on Jul 26, 2017 after a 44-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jul 26, 2017
- Review
- 44 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK171727 Hydrocleanse Antimicrobial Skin and Wound Care SolutionSonoma Pharmaceuticals · 2017
- Descendant · cites it directly · 3 of its ownK172622 Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals · 2017
- Descendant · 2 generations on · 1 of its ownK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK220286 ELECTROCYN somaV3Bio Sdn. Bhd · 2022
- Descendant · cites it directly · 0 of its ownK172851 Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals · 2017 · cites it directly3descendants
- K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024 · 2 generations on1descendant
- K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026 · 3 generations on0descendants
- K220286ELECTROCYN somaV3Bio Sdn. Bhd · 2022 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | Sonoma Pharmaceuticals | 2017 | — |
| +1 | K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | Sonoma Pharmaceuticals | 2017 | — |
| +2 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| +3 | K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026 | — |
| +2 | K220286 | ELECTROCYN soma | V3Bio Sdn. Bhd | 2022 | — |
| +1 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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?
- Of its descendants, K172622 (Sonoma Pharmaceuticals, 2017) has gone furthest, with 3 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. 2017, 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 | — |
https://510kreport.com/device/K171727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171727: Hydrocleanse Antimicrobial Skin and 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/K171727
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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