510(k) · Cleared
ClearedAsap 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 Apr 2, 2009 as substantially equivalent to K071703 (Swiss American Products, Inc., 2007) and 5 other predicates after a 231-day review. Its family tree reaches back 4 generations to 1992. 6 later devices descend from it.
- Decided
- Apr 2, 2009
- Review
- 231 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K914579 (1992). 17 ancestors in all, the oldest K890354 (1989). 6 later devices descend from it, 3 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 backK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
- This deviceK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · cites it directly · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · cites it directly · 1 of its ownK140483 Asap Otc Wound Dressing GelAbl Medical, LLC · 2014
- Descendant · cites it directly · 1 of its ownK131176 Ross RU Skin DiscontinuitiesBiotd S.A. · 2014
- Descendant · 2 generations on · 0 of its ownK212521 Field Shield Wound DressingKericure, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK162017 Ross Ru Wound Dressing GelBiotd S.A. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly2descendants
- K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 2014 · cites it directly1descendant
- K131176Ross RU Skin DiscontinuitiesBiotd S.A. · 2014 · cites it directly1descendant
- K212521Field Shield Wound DressingKericure, Inc. · 2024 · 2 generations on0descendants
- K162017Ross Ru Wound Dressing GelBiotd S.A. · 2017 · 2 generations on0descendants
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 | K023609 | Silverlon Adhesive Strip | Argentum International, LLC | 2003 | — |
| 0 (this device) | K082333 | Asap Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +1 | K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +1 | K140483 | Asap Otc Wound Dressing Gel | Abl Medical, LLC | 2014 | — |
| +1 | K131176 | Ross RU Skin Discontinuities | Biotd S.A. | 2014 | — |
| +2 | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K071703 | Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or…Summary page 1…n accordance with the requirements of 21 C.F.R. 807.92. The assigned 5 10(k) Number is: K082333 Predicate Devices: Elta Silver Antimicrobial Wound Gel Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (KO1 1994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron… | 2007 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | 2001 |
| * | K070333 | Acryderm Silver Antimicrobial Otc Wound GelSummary page 1…signed 5 10(k) Number is: K082333 Predicate Devices: Elta Silver Antimicrobial Wound Gel Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (KO1 1994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Bi… | 2007 |
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 1…lta Silver Antimicrobial Wound Gel Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (KO1 1994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Binding Dressing (K022483) Description of D… | 2006 |
| * | K023609 | Silverlon Adhesive StripSummary page 1…Dressing, WOU (K071703) AcryDerm Silver Antimicrobial Would Gel (KO1 1994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Binding Dressing (K022483) Description of Device: ASAP Wound Dressing Gel is… | 2003 |
| * | K022483 | Actisorb Silver 220 Antimicrobial Binding DressingSummary page 1…el (KO1 1994 and K070333) Silver Shield Antimicrobial Skin and Wound Gel (K062212) Silveron® Adhesive Strip (K023609) Actisorb Silver 220 Antimicrobial Binding Dressing (K022483) Description of Device: ASAP Wound Dressing Gel is an amorphous, water-based gel that contains silver hydrosol t… | 2003 |
What descends from it? (6)
3 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 17 ancestors has a recall of any class.
- Of its descendants, K092826 (American Biotech Labs, 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K071703.
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?
For the topical management of minor cuts, lacerations, abrasions, 1st and 2 nd degree bums, and skin irritations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082333: Asap 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/K082333
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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