510(k) · Cleared
ClearedTherabond Antimicrobial Barrier Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choice Therapeutics · FRO Dressing, Wound, Drug
Cleared on May 28, 2008 as substantially equivalent to K981299 (Argentum International, LLC, 1998) and 1 other predicate after a 196-day review. Its family tree reaches back 4 generations to 1992. 5 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 196 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914579 (1992). 6 ancestors in all, the oldest K890354 (1989). 5 later devices descend from it, 1 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 backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- This deviceK073213 Therabond Antimicrobial Barrier SystemsChoice Therapeutics · 2008
- Descendant · cites it directly · 4 of its ownK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
- Descendant · 2 generations on · 3 of its ownK190343 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
- Descendant · 3 generations on · 1 of its ownK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK241225 Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK212521 Field Shield Wound DressingKericure, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K150256Silverlon Burn Contact DressingsArgentum Medical · 2015 · cites it directly4descendants
- K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019 · 2 generations on3descendants
- K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022 · 3 generations on1descendant
- K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024 · 4 generations on0descendants
- K212521Field Shield Wound DressingKericure, Inc. · 2024 · 3 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 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| 0 (this device) | K073213 | Therabond Antimicrobial Barrier Systems | Choice Therapeutics | 2008 | — |
| +1 | K150256 | Silverlon Burn Contact Dressings | Argentum Medical | 2015 | — |
| +2 | K190343 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, LLC | 2019 | — |
| +3 | K221218 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, Inc. | 2022 | — |
| +4 | K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024 | — |
| +3 | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K981299 | Silverlon Contact Wound DressingSummary page 1…O - Dressing, Wound, Drug FDA Regulation: N/A Device Classification: Unclassified Predicate Devices: K981299: Silverlon Contact Wound Dressing (Argentum International, LLC)… | 1998 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…K981299: Silverlon Contact Wound Dressing (Argentum International, LLC) K023612: Antimicrobial Barrier Wound Contact Dressing, Bum Wrap, Bum Contact Dressing &… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150256 | Silverlon Burn Contact Dressings | 2015 | 4 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150256 (Argentum Medical, 2015) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K981299.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
TheraBond Antimicrobial Barrier Systems are indicated for use in light to moderately exuding partial and full thickness wounds including traumatic wounds, surgical wounds, donor sites, 1st and 2nd degree bums, as well as decubitus ulcers, diabetic ulcers and vascular ulcers. TheraBond may be used over debrided and partial thickness wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073213: Therabond Antimicrobial Barrier Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073213
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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