510(k) · Cleared
ClearedAquanova Super-Absorbent Gelling Dressing, Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 25, 2007 as substantially equivalent to K032986 (Scion Cardio-Vascular, Inc., 2004) and 1 other predicate after a 188-day review. Its family tree reaches back 5 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 25, 2007
- Review
- 188 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914575 (1991). 12 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 4 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 3 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 2 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 1 generation backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- This deviceK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK143124 KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK100693 Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial…Medtrade Products Limited · 2010
- Descendant · cites it directly · 0 of its ownK212766 Maxiocel Chitosan Wound DressingAdvamedica, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173005 SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd · 2018
- Descendant · 2 generations on · 0 of its ownK172010 gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015 · cites it directly2descendants
- K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited · 2010 · cites it directly1descendant
- K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc. · 2023 · cites it directly0descendants
- K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd · 2018 · cites it directly0descendants
- K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −4 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −3 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −2 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −1 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| 0 (this device) | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| +1 | K143124 | KA01 Chitosan Wound Dressing | Foshan United Medical Technologies, Ltd. | 2015 | — |
| +1 | K100693 | Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing | Medtrade Products Limited | 2010 | — |
| +1 | K212766 | Maxiocel Chitosan Wound Dressing | Advamedica, Inc. | 2023 | — |
| +1 | K173005 | SURECELL Gelling Fiber Wound Dressing | Jiangsu Newvalue Medical Producst Co.,Ltd | 2018 | — |
| +2 | K172010 | gel-e Bandage | Gel-E, Inc. (Formerly Remedium Technologies, Inc.) | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.0 · 5 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032986 | Clo-Surplusp.a.D.Summary page 6…on with an information leaflet. MedlTrade Products AQUANOVA Super-Absorbent Dressing is substantially equivalent to: * Scion Cardia-Vascular Inc. Clo-sur P.AD. K032986. It is similar to AQUANOVA in that it is a soft padt that provides an optimal wound-healing environment with exudates ma… | 2004 |
| * | K982116 | Aquacel Hydrofiber Wound DressingSummary page 6…cturers of Clo-sur P.AD. also make antibacterial claims that MedTrade do not wish to make for AQUANOVA. * Convatec's Aquacel Hydrofibre Wound Dressing K(982116. It is similar in intended use to AQUANOVA, both products gel in the presence of fluids to absorb large quantities of ex… | 1998 |
| * | — | MedTrade Products Celox Topical Hemostatic Granules Named without a submission number |
What descends from it? (6)
4 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 16 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K143124 (Foshan United Medical Technologies, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K032986.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MedTrade Products AQUANOVA Super-Absorbent Dressing OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin. Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have…
Read the full statement (132 words)
MedTrade Products AQUANOVA Super-Absorbent Dressing OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.
Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have been left to heal by secondary intention.
AQUANOVA may also be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds. AQUANOVA can be used in the control of minor bleeding.
Aditionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous turnours, cutaneous metastases and Kaposi's sarcomas).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070175: Aquanova Super-Absorbent Gelling Dressing, Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070175
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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