510(k) · Cleared
ClearedAquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products Limited · FRO Dressing, Wound, Drug
Cleared on Aug 10, 2010 as substantially equivalent to K070175 (Medtrade Products, Ltd., 2007) and 1 other predicate after a 152-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Aug 10, 2010
- Review
- 152 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914575 (1991). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 5 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 4 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 3 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 2 generations backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 1 generation backK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- This deviceK100693 Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial…Medtrade Products Limited · 2010
- Descendant · cites it directly · 0 of its ownK102965 Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze…Medtrade Products, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −5 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −4 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −3 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −2 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| −1 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| 0 (this device) | K100693 | Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing | Medtrade Products Limited | 2010 | — |
| +1 | K102965 | Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat… | Medtrade Products, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K070175 | Aquanova Super-Absorbent Gelling Dressing, OtcSummary page 1…ing, Wound, Drug Device Class: Unclassified Product Code: FRO 3. Predicate Device: AQUANOVA K070175 (Mectrade Products) AQUACEL Ag K080383 (ConvaTec) AQUANOVA Ag Super-Absorbent Dressing iss… | 2007 |
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 1…lassified Product Code: FRO 3. Predicate Device: AQUANOVA K070175 (Mectrade Products) AQUACEL Ag K080383 (ConvaTec) AQUANOVA Ag Super-Absorbent Dressing issubstantially equivalent… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102965 | Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma… | 2010 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K102965 (Medtrade Products, Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070175.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100693: Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100693
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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