510(k) · Cleared
ClearedThrombix Patch Thrombin Hemostasis Patch
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 Oct 5, 2007 as substantially equivalent to K030836 (Vascular Solutions, Inc., 2003) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 65 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896068 (1990). 6 ancestors in all. 2 later devices descend from it, 2 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 deviceK072117 Thrombix Patch Thrombin Hemostasis PatchVascular Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK083190 D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Vascular Solutions, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK102212 D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver…Vascular Solutions, Inc. · 2011
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 |
|---|---|---|---|---|---|
| −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) | K072117 | Thrombix Patch Thrombin Hemostasis Patch | Vascular Solutions, Inc. | 2007 | — |
| +1 | K083190 | D-Stat Dry Wrap Hemostatic Bandage, Model: 3015 | Vascular Solutions, Inc. | 2008 | — |
| +1 | K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix… | Vascular Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageSummary page 5…ode: FRO Regulation: Not Applicable Predicate Device(s) The predicate devices are the currently marketed D-Stat®Dry Topical Hemostat (K030836) and D-Stat® Dry 3x3 (K0405 10). Device Description The Thrombix TM Patch thrombin hemostasis patch consists of a lyophilized p… | 2003 |
| * | K040510 | Vascular Solutions D-Stat Dry 3X3 Hemostatic PadSummary page 5…egulation: Not Applicable Predicate Device(s) The predicate devices are the currently marketed D-Stat®Dry Topical Hemostat (K030836) and D-Stat® Dry 3x3 (K0405 10). Device Description The Thrombix TM Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived… | 2004 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K083190 (Vascular Solutions, Inc., 2008) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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 ThrombixTM Patch is applied topically and is indicated as an adjunct to manual compression and is indicated 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/K072117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072117: Thrombix Patch Thrombin Hemostasis Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072117
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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