510(k) · Cleared
ClearedElasto-Gel Manuka Honey Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southwest Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on Jul 30, 2009 as substantially equivalent to K872165 (Southwest Technologies, Inc., 1987) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 2007. 5 later devices descend from it.
- Decided
- Jul 30, 2009
- Review
- 260 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K053095 (2007). 3 ancestors in all, the oldest K872165 (1987). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 1 generation backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- This deviceK083334 Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK182725 ApisSweetbio, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK102478 Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK211972 Omeza Collagen MatrixOmeza, LLC · 2021
- Descendant · cites it directly · 0 of its ownK101114 Advancis Activon TubeAdvancis Medical · 2011
Most influential descendants
Showing 5 of 5 · See all- K182725ApisSweetbio, Inc. · 2019 · cites it directly2descendants
- K102478Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2010 · cites it directly1descendant
- K222143Apis (R), Veris (TM)Sweetbio, Inc. · 2023 · 2 generations on0descendants
- K211972Omeza Collagen MatrixOmeza, LLC · 2021 · 2 generations on0descendants
- K101114Advancis Activon TubeAdvancis Medical · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −1 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| 0 (this device) | K083334 | Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies, Inc. | 2009 | — |
| +1 | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| +1 | K102478 | Otc Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies, Inc. | 2010 | — |
| +2 | K222143 | Apis (R), Veris (TM) | Sweetbio, Inc. | 2023 | — |
| +2 | K211972 | Omeza Collagen Matrix | Omeza, LLC | 2021 | — |
| +1 | K101114 | Advancis Activon Tube | Advancis Medical | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K872165 | Elasto-Gel Occlusive DressingSummary page 1…Substantial Equivalec C im- Predicate Devices Legally marketed~edO e Elasto-Gel Occlutsive Dressing by Southwest Technologies(K872 165) / Derma Sciences APE~ Active Manuka Honey Absorbent DressingbDem Sciences… | 1987 |
| Kept off the family tree | K053395 | FDA’s K053395 is BP Pro Blood Pressure Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K072956 | Medihoney Primary Dressings with Active Manuka HoneySummary page 1…V Derma Sciences MeihoniieyNPrimary Dressings- with Active Manuka Hone byDraSciences l(K072956)' 4. Device Description < N~ V7… | 2007 |
What descends from it? (5)
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 2 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K182725 (Sweetbio, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K872165.
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?
Elasto-gel Manuka Honey wound Dressings are indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers, (stages 1-IV) venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds, and surgical wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083334: Elasto-Gel Manuka Honey Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083334
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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