510(k) · Cleared
ClearedSilvacide Skin & Wound Moisturizing Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Molecular Therapuetics, LLC · FRO Dressing, Wound, Drug
Cleared on Jul 3, 2007 as substantially equivalent to K042729 (Oculus Innovative Sciences, Inc., 2005) and 5 other predicates after a 270-day review. Its family tree reaches back 4 generations to 1992. 14 later devices descend from it.
- Decided
- Jul 3, 2007
- Review
- 270 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K914579 (1992). 28 ancestors in all, the oldest K890354 (1989). 14 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- This deviceK063063 Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · cites it directly · 13 of its ownK083355 Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML…Blairex Laboratories, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · 3 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · 3 generations on · 1 of its ownK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008 · cites it directly13descendants
- K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · 2 generations on8descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 3 generations on4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 3 generations on3descendants
- K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| 0 (this device) | K063063 | Silvacide Skin & Wound Moisturizing Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +1 | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | Blairex Laboratories, Inc. | 2008 | — |
| +2 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +3 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +3 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +3 | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K042729 | Dermacyn Wound IrrigationSummary page 1…ing Solution Classification Name: Liquid Bandage KMF 7.4 Predicate Devices 807.92(a)(3) Dermacyn Wound Cleanser K 042729 Saline Solution (Wound Dressing) K040683 Restore Wound Cleanser… | 2005 |
| * | K040683 | Bioderm Sciences Wound DressingSummary page 1…7.4 Predicate Devices 807.92(a)(3) Dermacyn Wound Cleanser K 042729 Saline Solution (Wound Dressing) K040683 Restore Wound Cleanser K022670 Dermacyn Wound Irrigation… | 2004 |
| * | K022670 | Carraklenz and UltraklenzSummary page 1…K 042729 Saline Solution (Wound Dressing) K040683 Restore Wound Cleanser K022670 Dermacyn Wound Irrigation K042729 5 ===… | 2002 |
| * | K040019 | SilversealSummary page 2…ication K063063 Rev 15 May 07 Silvion Antibacterial Silver Skin & Wound Moisturizing Solution X-Static Silverseal Hydrogel Wound Dressing K040019 Acryderm Silver Antimicrobial Wound Gel KO1 1994 Antimicrobial Barrier Wound Contact Dressing… | 2004 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | 2001 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 2…nd Dressing K040019 Acryderm Silver Antimicrobial Wound Gel KO1 1994 Antimicrobial Barrier Wound Contact Dressing K023612 7.5 Device Description A buffered ionic silver aqueous wet dressing for external wound management. The product provides a moi… | 2003 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | 2008 | 13 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K083355 (Blairex Laboratories, Inc., 2008) has gone furthest, with 13 descendants of its own.
- 10 other devices also cite its predicate K042729.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 minor bums, abraded skin, irritated areas and minor wounds.
Wound moistening solution for dermal lesions such as Stage I-IV pressure ulcers, stasis ulcers, foot ulcers, diabetic ulcers, post surgical wounds, first and second degree bums, abrasions and skin irritations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063063: Silvacide Skin & Wound Moisturizing Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063063
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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