510(k) · Cleared
ClearedWoundstat, Model TC1001
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 Aug 23, 2007 as substantially equivalent to K013390 (On Site Gas Systems, Inc., 2002) after a 41-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Aug 23, 2007
- Review
- 41 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002550 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 1 generation backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- This deviceK071936 Woundstat, Model TC1001Traumacure, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK081183 WoundstatTraumacure, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK153138 Cerdak BasicBu Polysciences Equipment & Trading, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK082601 UltraClot, UltraClot OTCEmergency Medical Devices, LLC · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −1 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | K071936 | Woundstat, Model TC1001 | Traumacure, Inc. | 2007 | — |
| +1 | K081183 | Woundstat | Traumacure, Inc. | 2008 | — |
| +1 | K153138 | Cerdak Basic | Bu Polysciences Equipment & Trading, LLC | 2017 | — |
| +2 | K082601 | UltraClot, UltraClot OTC | Emergency Medical Devices, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K013390 | QuickclotSummary page 5…ressing Device Class: Unclassified Predicate Device: QuikClot® Z-Medica Corporation K013390 Intended Use: WoundStatT M is intended for use in emergency wound management. Indic… | 2002 |
What descends from it? (3)
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 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081183 (Traumacure, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K013390.
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?
WoundStatTM is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071936: Woundstat, Model TC1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071936
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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