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 Apr 14, 2005 as substantially equivalent to K030836 (Vascular Solutions, Inc., 2003) after a 44-day review. Its family tree reaches back 4 generations to 1990. 25 later devices descend from it.
- Decided
- Apr 14, 2005
- Review
- 44 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896068 (1990). 5 ancestors in all. 25 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 3 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 2 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 1 generation backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- This deviceK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- Descendant · 3 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · 3 generations on · 3 of its ownK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K072900Excelarrest FoamHemostasis, LLC · 2007 · cites it directly19descendants
- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
- K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012 · 2 generations on6descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 3 generations on5descendants
- K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc. · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −3 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −2 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −1 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| 0 (this device) | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| +1 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +2 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| +3 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +3 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid… | Hem Con Medical Technologies, Inc. | 2015 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage Our reading of the summary gave K130836, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Vascular Solutions, Inc., in this field. | 2003 |
| Kept off the family tree | K122093 | D-Stat Flowable Hemostat Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…f the device foir its intended use Predicate Devices: D-Stat Dr Illeniostatic Bandage (KI30836) D-Stat [:low'lle I lnciostit (KI122093) Conclusions: l'he 'Ihromhi( i; foiam hemostat pad is sulistMntially equivalent to the… |
What descends from it? (25)
See all 254 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 15 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K072900 (Hemostasis, LLC, 2007) has gone furthest, with 19 descendants of its own.
- 7 other devices also cite its predicate K030836.
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/K050511 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050511: Thrombigel Thrombin/Gelatin Foam Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050511
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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