510(k) · Cleared
ClearedAlevicyn SG Antimicrobial Gel
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 Dec 1, 2017 as substantially equivalent to K152945 (Oculus Innovative Sciences, 2015) and 1 other predicate after a 156-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- Dec 1, 2017
- Review
- 156 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K914579 (1992). 56 ancestors in all, the oldest K830708 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations between
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK173896 Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 7 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 6 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 5 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 4 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −8 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −7 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −6 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −5 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −3 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −2 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| −1 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| 0 (this device) | K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K152945 | Alevicyn SG Antipruritic GelSummary page 4…al Name: Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO III. PREDICATE DEVICE Alevicyn SG Antipruritic Gel (K152945) manufactured by Sonoma Pharmaceuticals, Inc. Puracyn Plus Antimicrobial Gel (K150799), manufactured by Innovacyn, Inc. IV. R… | 2015 |
| * | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Summary page 4…sified Product Code: FRO III. PREDICATE DEVICE Alevicyn SG Antipruritic Gel (K152945) manufactured by Sonoma Pharmaceuticals, Inc. Puracyn Plus Antimicrobial Gel (K150799), manufactured by Innovacyn, Inc. IV. REFERENCE DEVICE Alevicyn SG Gel (K143590) manufactured by Sonoma Pharmaceuticals, Inc.… | 2015 |
| † | K143590 | Alevicyn SG Antipruritic Gel | 2015 |
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 |
|---|---|---|---|
| K173896 | Microcyn Antimicrobial Hydrogel | 2018 | 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 25 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 56 ancestors has a recall of any class.
- Of its descendants, K173896 (Sonoma Pharmaceuticals, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152945.
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 | — |
What is it indicated for?
Rx Indications: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborrhea and seborrheic dermatitis, dermal irritation, sores, injuries, and ulcers of…
Read the full statement (215 words)
Rx Indications: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborrhea and seborrheic dermatitis, dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171935: Alevicyn SG Antimicrobial Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171935
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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