510(k) · Cleared
ClearedAlevicyn SG Antipruritic Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences · FRO Dressing, Wound, Drug
Cleared on Jun 4, 2015 as substantially equivalent to K102945 (Oculus Innovative Sciences, Inc., 2011) after a 168-day review. Its family tree reaches back 6 generations to 1983. 4 later devices descend from it.
- Decided
- Jun 4, 2015
- Review
- 168 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K830708 (1983). 16 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 5 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 4 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 3 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 2 generations backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- 1 generation backK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- This deviceK143590 Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015
- Descendant · cites it directly · 3 of its ownK152945 Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015
- Descendant · 2 generations on · 1 of its ownK171935 Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK173896 Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK162217 LOYONOculus Innovative Sciences · 2017
Most influential descendants
Showing 4 of 4 · See all- K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences · 2015 · cites it directly3descendants
- K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc. · 2017 · 2 generations on1descendant
- K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc. · 2018 · 3 generations on0descendants
- K162217LOYONOculus Innovative Sciences · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −5 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −4 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −3 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| −1 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| 0 (this device) | K143590 | Alevicyn SG Antipruritic Gel | Oculus Innovative Sciences | 2015 | — |
| +1 | K152945 | Alevicyn SG Antipruritic Gel | Oculus Innovative Sciences | 2015 | — |
| +2 | K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017 | — |
| +3 | K173896 | Microcyn Antimicrobial Hydrogel | Sonoma Pharmaceuticals, Inc. | 2018 | — |
| +2 | K162217 | LOYON | Oculus Innovative Sciences | 2017 | — |
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 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102945 | Pediacyn Atopic Dermatitis HydrogelSummary page 4…sing, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO III. PREDICATE DEVICE Epicyn Hydrogel manufactured by Oculus Innovative Sciences (K102945) IV. DEVICE DESCRIPTION The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. T… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152945 | Alevicyn SG Antipruritic Gel | 2015 | 3 |
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 32 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K152945 (Oculus Innovative Sciences, 2015) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K102945.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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: Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing…
Read the full statement (119 words)
Rx: Rx Indication: Alevicyn SG Antipruritic Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Alevicyn SG Antipruritic Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Antipruritic Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
OTC Indication: Alevicyn SG Antipruritic Gel is intended to relieve the burning and itching associated with many common types of skin irritation, lacerations, abrasions, and minor burns. Alevicyn SG Antipruritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143590: Alevicyn SG Antipruritic Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143590
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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