510(k) · Cleared
ClearedSilverseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noble Fiber Technologies · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jul 23, 2004 as substantially equivalent to K980132 (Phytatek Laboratories, Inc., 1998) and 7 other predicates after a 199-day review. Its family tree reaches back 3 generations to 1997. 97 later devices descend from it.
- Decided
- Jul 23, 2004
- Review
- 199 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K973688 (1997). 11 ancestors in all, the oldest K894541 (1989). 97 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 2 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- This deviceK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · cites it directly · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 2 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 3 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 4 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 2 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 3 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 3 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −2 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +1 | 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 | — |
| +3 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +4 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 13 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K980132 | Phytacare Alginate Hydrogel Wound DressingSummary page 1…based), and nylon fibers with a metallic silver surface. *It is substantially equivalent to phytacare Alginate Hydrogel Wound Dressing (K980132, PhytaTek Laboratories, Inc.), BurnFree Sterile Burn & Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel… | 1998 |
| * | K010583 | Ambu Gel, Hydrogel Burn DressingSummary page 1…ally equivalent to phytacare Alginate Hydrogel Wound Dressing (K980132, PhytaTek Laboratories, Inc.), BurnFree Sterile Burn & Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydro… | 2001 |
| * | K022995 | Collatek HydrogelSummary page 1…Dressing (K980132, PhytaTek Laboratories, Inc.), BurnFree Sterile Burn & Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound… | 2002 |
| * | K991202 | Modification to Woun'dresSummary page 1…& Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound Dressing, (K983362, Johnson & Johnson), DuoDerm Hydroactive Gel Dress… | 1999 |
| * | K983362 | NU-Gel * Wound DressingSummary page 1…Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound Dressing, (K983362, Johnson & Johnson), DuoDerm Hydroactive Gel Dressing, (K990368, Convatec, Div. Of E.R. Squibb & Sons, Inc.),… | 1998 |
| * | K990368 | Duoderm Hydroactive Gel Wound DressingSummary page 1…Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound Dressing, (K983362, Johnson & Johnson), DuoDerm Hydroactive Gel Dressing, (K990368, Convatec, Div. Of E.R. Squibb & Sons, Inc.), Acryderm Silver Antimicrobial Wound Gel #A, (K011994, Acrymed,… | 1999 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Summary page 1…hnson), DuoDerm Hydroactive Gel Dressing, (K990368, Convatec, Div. Of E.R. Squibb & Sons, Inc.), Acryderm Silver Antimicrobial Wound Gel #A, (K011994, Acrymed, Inc.), Acticoat Composite Dressing (K002466, Westaim Biomedical, Inc.) 10.1.4 Devic… | 2001 |
| * | K002466 | Acticoat Composite DressingSummary page 1…nvatec, Div. Of E.R. Squibb & Sons, Inc.), Acryderm Silver Antimicrobial Wound Gel #A, (K011994, Acrymed, Inc.), Acticoat Composite Dressing (K002466, Westaim Biomedical, Inc.) 10.1.4 Device Description Eplanation of how the device functions:… | 2001 |
What descends from it? (97)
See all 973 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K063069 (Medical Molecular Therapuetics, LLC, 2007) has gone furthest, with 73 descendants of its own.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The X-Static® SilversealTM Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040019: Silverseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040019
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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