510(k) · Cleared
ClearedSilcryst Silver Antimicrobial Wound Cream, Model a-00901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucryst Pharmaceuticals, Inc. · FRO Dressing, Wound, Drug
Cleared on Jul 13, 2007 as substantially equivalent to K042352 (Bioderm Sciences, Inc., 2005) and 2 other predicates after a 203-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jul 13, 2007
- Review
- 203 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945802 (1995). 19 ancestors in all, the oldest K914579 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 5 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 4 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 3 generations backK040779 Restore Wound CleanserHollister, Inc. · 2004
- 2 generations backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- 1 generation backK042352 Bioderm Sciences Wound CreamBioderm Sciences, Inc. · 2005
- This deviceK063805 Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −5 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −4 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −3 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| −2 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| −1 | K042352 | Bioderm Sciences Wound Cream | Bioderm Sciences, Inc. | 2005 | — |
| 0 (this device) | K063805 | Silcryst Silver Antimicrobial Wound Cream, Model a-00901 | Nucryst Pharmaceuticals, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K042352 | Bioderm Sciences Wound CreamSummary page 1…. believes that Silcryst® Silver Antimicrobial Wound Cream is substantially equivalent to the currently marketed devices, Bioderm Sciences Wound Cream cleared under K042352, Acryderm Silver Antimicrobial Wound Gel cleared under K0 11994, and Acticoat T M Antimicrobial Barrier Dressing cleare… | 2005 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Summary page 1…ntially equivalent to the currently marketed devices, Bioderm Sciences Wound Cream cleared under K042352, Acryderm Silver Antimicrobial Wound Gel cleared under K0 11994, and Acticoat T M Antimicrobial Barrier Dressing cleared under K955453. 4. Device Description: Silcryst® Silver Anti… | 2001 |
| * | K955453 | Acticoat Silver Coated DressingSummary page 1…ound Cream cleared under K042352, Acryderm Silver Antimicrobial Wound Gel cleared under K0 11994, and Acticoat T M Antimicrobial Barrier Dressing cleared under K955453. 4. Device Description: Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for t… | 1996 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 19 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. 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?
Sileryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous'stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063805: Silcryst Silver Antimicrobial Wound Cream, Model a-00901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063805
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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