510(k) · Cleared
ClearedAsap Antimicrobial Silver Wound Dressing Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Biotech Labs · FRO Dressing, Wound, Drug
Cleared on Nov 12, 2009 as substantially equivalent to K082333 (American Biotech Labs, 2009) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Nov 12, 2009
- Review
- 59 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914579 (1992). 19 ancestors in all, the oldest K890354 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
- 1 generation backK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
- This deviceK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · cites it directly · 0 of its ownK212521 Field Shield Wound DressingKericure, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK162017 Ross Ru Wound Dressing GelBiotd S.A. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K023609 | Silverlon Adhesive Strip | Argentum International, LLC | 2003 | — |
| −1 | K082333 | Asap Wound Dressing Gel | American Biotech Labs | 2009 | — |
| 0 (this device) | K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +1 | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
| +1 | K162017 | Ross Ru Wound Dressing Gel | Biotd S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K082333 | Asap Wound Dressing GelSummary page 1…egulation: Unclassified, pre-amendment Panel: General & Plastic Surgery Product Code: FRO Predicate Devices: K082333 - ASAP® Wound Dressing Gel K083103 -AcryDerm Antimicrobial Silver Wound Gel… | 2009 |
| * | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #BSummary page 1…General & Plastic Surgery Product Code: FRO Predicate Devices: K082333 - ASAP® Wound Dressing Gel K083103 -AcryDerm Antimicrobial Silver Wound Gel Dressing Model #B Indication for Use: ASAP®… | 2009 |
What descends from it? (2)
2 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 17 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K212521 (Kericure, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082333.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
ASAP® Antibacterial Silver Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092826 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092826: Asap Antimicrobial Silver Wound Dressing Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092826
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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