510(k) · Cleared
ClearedSkinSmart Antimicrobial HydroGel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magic Science Supply, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 11, 2026 as substantially equivalent to K150799 (Innovacyn, Inc., 2015) after a 269-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Sep 11, 2026
- Review
- 269 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K914579 (1992). 49 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- 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 deviceK254041 SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
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 deviceK254041 SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
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) | K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026 | — |
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 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Summary page 5…e following predicate device as related to intended use, design, and material characteristics which have received FDA clearance for distribution under 510(k): • K150799, Manufactured by Innovacyn Incorporated. Cleared on May 2, 2025 Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydroge… | 2015 |
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 34 years and passes through 9 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 49 ancestors has a recall of any class.
- 4 other devices also cite its predicate K150799.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
For Over-the-Counter Use: For the Management of minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns.
Prescription Use: For use by healthcare professionals or as directed to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot, leg ulcers, post-surgical wounds, first-and superficial second-degree burns, surgical wounds (donor and graft sites, incisions), trauma wounds, in addition to moistening and lubricating absorbent wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254041: SkinSmart 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/K254041
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026