510(k) · Cleared
ClearedApis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sweetbio, Inc. · FRO Dressing, Wound, Drug
Cleared on May 31, 2019 as substantially equivalent to K083334 (Southwest Technologies, Inc., 2009) and 1 other predicate after a 245-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it.
- Decided
- May 31, 2019
- Review
- 245 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881854 (1988). 16 ancestors in all, the oldest K872165 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 6 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 5 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 4 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 3 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 2 generations backK090812 Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009
- 1 generation backK112580 Collagen Wound DressingDalim Tissen Co., Ltd. · 2012
- This deviceK182725 ApisSweetbio, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK211972 Omeza Collagen MatrixOmeza, LLC · 2021
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 |
|---|---|---|---|---|---|
| −7 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −6 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −5 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −4 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −3 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −2 | K090812 | Theraform Standard/Sheet | Sewon Cellontech Co., Ltd. | 2009 | — |
| −1 | K112580 | Collagen Wound Dressing | Dalim Tissen Co., Ltd. | 2012 | — |
| 0 (this device) | K182725 | Apis | Sweetbio, Inc. | 2019 | — |
| +1 | K222143 | Apis (R), Veris (TM) | Sweetbio, Inc. | 2023 | — |
| +1 | K211972 | Omeza Collagen Matrix | Omeza, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083334 | Elasto-Gel Manuka Honey Wound DressingSummary page 4…to the predicate devices shown in Table 1-1. Predicate 510(k) Number Device Manufacturer Primary K083334 Elasto-Gel Manuka Honey Wound Dressing Southwest Technologies, Inc Reference K112580 Collagen W… | 2009 |
| * | K112580 | Collagen Wound DressingSummary page 4…Manufacturer Primary K083334 Elasto-Gel Manuka Honey Wound Dressing Southwest Technologies, Inc Reference K112580 Collagen Wound Dressing Dalim Tissen Co., Ltd Table 1-1… | 2012 |
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 31 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K222143 (Sweetbio, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083334.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Apis is indicated for use in management of wounds, including
• full and partial thickness wounds
• pressure ulcers (stages I-IV)
• venous stasis ulcers
• diabetic ulcers
• abrasion
• surface wounds
• traumatic wounds (healing by secondary intention)
• donor site wounds
• surgical wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182725: Apis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182725
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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