510(k) · Cleared
ClearedWoundstat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Traumacure, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jun 19, 2008 as substantially equivalent to K071936 (Traumacure, Inc., 2007) after a 55-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jun 19, 2008
- Review
- 55 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002550 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 2 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 1 generation backK071936 Woundstat, Model TC1001Traumacure, Inc. · 2007
- This deviceK081183 WoundstatTraumacure, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK082601 UltraClot, UltraClot OTCEmergency Medical Devices, LLC · 2008
Most influential descendants
Showing 1 of 1 · See all- K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −2 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −1 | K071936 | Woundstat, Model TC1001 | Traumacure, Inc. | 2007 | — |
| 0 (this device) | K081183 | Woundstat | Traumacure, Inc. | 2008 | — |
| +1 | K082601 | UltraClot, UltraClot OTC | Emergency Medical Devices, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K071936 | Woundstat, Model TC1001Summary page 5…Dressing Device Class: Unclassified Predicate Device: WoundStatTM TraumaCure, Inc. K071936 Intended Use: WoundStatTM is intended for use in emergency wound management. Indica… | 2007 |
| † | K070010 | Quikclot Sport and Quikclot Sport Silver | 2007 |
| † | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762… | 2006 |
| † | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | 2007 |
| † | K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27… | 2007 |
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 |
|---|---|---|---|
| K082601 | UltraClot, UltraClot OTC | 2008 | 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 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082601 (Emergency Medical Devices, LLC, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071936.
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. 2008, 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?
WoundStatTM wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081183 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081183: Woundstat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081183
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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