510(k) · Cleared
ClearedSilverStream Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enzysurge, Ltd. · FRO Dressing, Wound, Drug
Cleared on Oct 8, 2020 as substantially equivalent to K093227 (Enzysurge, Ltd., 2009) after a 197-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Oct 8, 2020
- Review
- 197 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914579 (1992). 27 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 5 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 4 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 3 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 2 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 1 generation backK093227 Silverstream and DermaseptEnzysurge, Ltd. · 2009
- This deviceK200767 SilverStream GelEnzysurge, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −6 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −5 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −4 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −3 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −2 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −1 | K093227 | Silverstream and Dermasept | Enzysurge, Ltd. | 2009 | — |
| 0 (this device) | K200767 | SilverStream Gel | Enzysurge, Ltd. | 2020 | — |
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 |
| 2006 | 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 |
|---|---|---|---|
| * | K093227 | Silverstream and DermaseptSummary page 4…e: FRO Device Classification: Unclassified Panel: General & Plastic Surgery Predicate Device: SilverStream® [K093227] Intended Use / Indication for Use: Prescription Use SilverStream Gel is intended for use under the supervision of a healthcare… | 2009 |
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 28 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 27 ancestors has a recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
SilverStream Gel is intended for use under the supervision of a healthcare professional for management and moisturizing
of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, cuts abrasions and minor skin irritations.
SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200767: SilverStream Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200767
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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