510(k) · Cleared
ClearedThrombigel Thrombin/Gelatin Foam Hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Cleared on Feb 9, 2006 as substantially equivalent to K050511 (Vascular Solutions, Inc., 2005) after a 41-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 9, 2006
- Review
- 41 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896068 (1990). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 4 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 3 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 2 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 1 generation backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- This deviceK053644 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK063860 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK080022 Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK070938 Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatVascular Solutions, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K063860Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2007 · cites it directly2descendants
- K080022Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008 · 2 generations on0descendants
- K070938Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatVascular Solutions, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −4 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −3 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −2 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −1 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| 0 (this device) | K053644 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2006 | — |
| +1 | K063860 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2007 | — |
| +2 | K080022 | Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp | Vascular Solutions, Inc. | 2008 | — |
| +2 | K070938 | Thrombi-Paste Thrombin/Gelatin Powder Paste Hemostat | Vascular Solutions, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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 QSX? 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 QSX device
- #1 K200720 D-Stat Radial Topical Hemostatscore 0.8 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063860 | Thrombigel Thrombin/Gelatin Foam Hemostat | 2007 | 2 |
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 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K063860 (Vascular Solutions, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K050511.
How does its category compare?
All QSX devicesQSX Hemostatic Wound Dressing With Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QSX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QSX
56in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSX
No recall names QSX since 2007.
Adverse event reports per year · QSX
No MAUDE report names QSX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 56 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ThrombiGel thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053644: Thrombigel Thrombin/Gelatin Foam Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053644
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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