510(k) · Cleared
ClearedTraumagel®
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 Aug 14, 2024 as substantially equivalent to K113560 (Medtrade Products, Ltd., 2012) and 1 other predicate after a 152-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 14, 2024
- Review
- 152 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002550 (2000). 12 ancestors in all, the oldest K972914 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 4 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 3 generations backK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- 2 generations backK080097 Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008
- 1 generation backK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- This deviceK240713 Traumagel®Cresilon, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250319 Mfuse (MS001)Machina Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253609 TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −4 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −3 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
| −2 | K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2008 | — |
| −1 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| 0 (this device) | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
| +1 | K250319 | Mfuse (MS001) | Machina Medical, Inc. | 2025 | — |
| +1 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 K253017 BloodSTOP iX Trauma Matrix (TM-iX-20)score 13.1 · 7 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 |
|---|---|---|---|
| * | K113560 | Celox Gauze ProSummary page 5…General & Plastic Surgery Product Code: QSY Regulation Number Not Applicable Predicate Device: CELOX Gauze Pro (K113560) Device Description TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device… | 2012 |
| * | K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Summary page 7…RO 510(k) # granules suspended in a chitosan granules suspended within a Device Design K093593) adhered onto a sodium alginate gel and sodium alginate gel, whereas Celox… | 2010 |
What descends from it? (2)
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 24 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K250319 (Machina Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113560.
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. 2024, 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?
TRAUMAGEL® 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/K240713 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240713: Traumagel®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240713
Report an extraction error
Are you the manufacturer?
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