510(k) · Cleared
Recalled · Class II · 2019Elasto-Gel Occlusive 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 Jun 26, 1987 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 26, 1987
- Review
- 21 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK872165 Elasto-Gel Occlusive DressingSouthwest Technologies, Inc. · 1987
- Descendant · cites it directly · 5 of its ownK083334 Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK053613 L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 2007
- Descendant · 2 generations on · 2 of its ownK182725 ApisSweetbio, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK110546 Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK102478 Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083334Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009 · cites it directly5descendants
- K053613L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 2007 · cites it directly3descendants
- K182725ApisSweetbio, Inc. · 2019 · 2 generations on2descendants
- K110546Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 2011 · 2 generations on1descendant
- K102478Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872165 | Elasto-Gel Occlusive Dressing | Southwest Technologies, Inc. | 1987 | — |
| +1 | K083334 | Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies, Inc. | 2009 | — |
| +1 | K053613 | L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active | Theo Manufacturing BV | 2007 | — |
| +2 | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| +2 | K110546 | Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey | Derma Sciences, Inc. | 2011 | 5 |
| +1 | K102478 | Otc Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-0687-2020 | Equipment maintenance | Elasto-Gel Wound Dressing may be contaminated with mold. |
| Mar 27, 2006 | Not classified | Z-0841-06 | Other | The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083334 (Southwest Technologies, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K872165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K872165: Elasto-Gel Occlusive Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872165
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026