510(k) · Cleared
ClearedSilvaklenz Skin and Wound Clenser 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 13, 2007 as substantially equivalent to K042729 (Oculus Innovative Sciences, Inc., 2005) and 4 other predicates after a 280-day review. Its family tree reaches back 4 generations to 1992. 73 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 280 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K914579 (1992). 23 ancestors in all, the oldest K890354 (1989). 73 later devices descend from it, 6 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 deviceK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · cites it directly · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 2 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 3 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- Descendant · 2 generations on · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · cites it directly66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 2 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 2 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 3 generations on25descendants
- K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · 2 generations on21descendants
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) | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +1 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +2 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +2 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +3 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| +2 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 11 | 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? (5)
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…SilvaklenZTM Classification Name: Liquid Bandage KMF 7.4 Predicate Devices 807.92(a)(3) Dermacyn Wound Cleanser K042729 Restore Wound Cleanser K022670 X-Static Silverseal Hydrogel Wound Dressing K04… | 2005 |
| * | K022670 | Carraklenz and UltraklenzSummary page 1…ge KMF 7.4 Predicate Devices 807.92(a)(3) Dermacyn Wound Cleanser K042729 Restore Wound Cleanser K022670 X-Static Silverseal Hydrogel Wound Dressing K040019 Acryderm Silver Antimicrobial Wound Gel K01… | 2002 |
| * | K040019 | SilversealSummary page 1…leanser K042729 Restore Wound Cleanser K022670 X-Static Silverseal Hydrogel Wound Dressing K040019 Acryderm Silver Antimicrobial Wound Gel K01 1994 Antimicrobial Barrier Wound Contact Dressing K0… | 2004 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Summary page 1…eanser K022670 X-Static Silverseal Hydrogel Wound Dressing K040019 Acryderm Silver Antimicrobial Wound Gel K01 1994 Antimicrobial Barrier Wound Contact Dressing K023612… | 2001 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…al Hydrogel Wound Dressing K040019 Acryderm Silver Antimicrobial Wound Gel K01 1994 Antimicrobial Barrier Wound Contact Dressing K023612 6 Medical Molecular T… | 2003 |
What descends from it? (73)
See all 736 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel | 2008 | 66 |
| K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | 2008 | 13 |
| K111313 | Exsept Skin and Wound Cleanser with Antimicrobial Preservative | 2011 | 9 |
| K093227 | Silverstream and Dermasept | 2009 | 1 |
| K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash… | 2016 | 0 |
| K082858 | Exsept WC Antimicrobial Skin and Wound Cleanser | 2009 | 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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K073547 (Anacapa Technologies, Inc., 2008) has gone furthest, with 66 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 normal skin and minor wounds, ulcerations and bums, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action.
To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree bums, cuts, abrasions and minor skin irritations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063069: Silvaklenz Skin and Wound Clenser Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063069
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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