510(k) · Cleared
ClearedTRAUMAGEL® 2.0 Hemostatic Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cresilon, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 12, 2025 as substantially equivalent to K240713 (Cresilon, Inc., 2024) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Dec 12, 2025
- Review
- 24 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K972914 (1997). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
- 6 generations backK023298 Hemcon BandageHemcon, Inc. · 2002
- 5 generations backK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
- 4 generations backK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
- 3 generations backK072486 Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · Recalled
- 2 generations backK180152 gel-e FlexGel-E, Inc. · 2018
- 1 generation backK213652 Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc. · 2023
- This deviceK253609 TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K972914 | Syvek Patch | Marine Polymer Technologies, Inc. | 1997 | — |
| −6 | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| −5 | K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | Hemcon, Inc. | 2003 | — |
| −4 | K043050 | Hemcon Bandage and Hemcon Bandage Otc | Hemcon, Inc. | 2005 | — |
| −3 | K072486 | Modification to Hemcon Bandage and Hemcon Bandage Otc | Hem Con Medical Technologies, Inc. | 2008 | 6 |
| −2 | K180152 | gel-e Flex | Gel-E, Inc. | 2018 | — |
| −1 | K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023 | — |
| 0 (this device) | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K240713 | Traumagel®Summary page 6…g. Substantial Equivalence: List of Predicate Devices 510(k) Number Type of Predicate TRAUMAGEL® Hemostatic Gel K240713 Primary Predicate Cresilon Hemostatic Gel™ (CHG™) K213652 Reference Predicate TRAUMAGEL® Hem… | 2024 |
| * | K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Summary page 6…Number Type of Predicate TRAUMAGEL® Hemostatic Gel K240713 Primary Predicate Cresilon Hemostatic Gel™ (CHG™) K213652 Reference Predicate TRAUMAGEL® Hemostatic Gel (K240713) is the primary predicate manufactured by Cresilon, Inc. Both th… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 1 other device also cites its predicate K240713.
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. 2025, 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?
TRAUAMGEL® 2.0 is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253609 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253609: TRAUMAGEL® 2.0 Hemostatic Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253609
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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