510(k) · Cleared
ClearedMicrocyn Antimicrobial 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 Apr 2, 2018 as substantially equivalent to K153648 (Oculus Innovative Sciences, 2016) and 1 other predicate after a 101-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 2, 2018
- Review
- 101 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K914579 (1992). 58 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations between
- 3 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 2 generations backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- 1 generation backK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- This deviceK173896 Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 8 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 7 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 6 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 5 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 4 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 3 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 2 generations backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- 1 generation backK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- This deviceK173896 Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −9 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −8 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −7 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −6 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −5 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −4 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −3 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| −2 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| −1 | K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017 | — |
| 0 (this device) | K173896 | Microcyn Antimicrobial Hydrogel | Sonoma Pharmaceuticals, Inc. | 2018 | — |
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 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K153648 | Microcyn Plus Skin and Wound HydrogelSummary page 4…Wound, Drug Regulatory Class: Unclassified Product Code: FRO III. PREDICATE DEVICE Microcyn Plus Skin and Wound Gel manufactured by Oculus Innovative Sciences (K153648) and Alevicyn SG Antimicrobial Gel by Sonoma Pharmaceuticals, Inc., (K171935) IV. DEVICE DESCRIPTION The Microcyn Antim… | 2016 |
| * | K171935 | Alevicyn SG Antimicrobial GelSummary page 4…EDICATE DEVICE Microcyn Plus Skin and Wound Gel manufactured by Oculus Innovative Sciences (K153648) and Alevicyn SG Antimicrobial Gel by Sonoma Pharmaceuticals, Inc., (K171935) IV. DEVICE DESCRIPTION The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel… | 2017 |
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 26 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 58 ancestors has a recall of any class.
- 1 other device also cites its predicate K153648.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor…
Read the full statement (100 words)
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173896: Microcyn Antimicrobial Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173896
Report an extraction error
Are you the manufacturer?
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