510(k) · Cleared
ClearedOMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Product, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 18, 2019 as substantially equivalent to K093519 (Medtrade Products, Ltd., 2010) after a 349-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Dec 18, 2019
- Review
- 349 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K953781 (1995). 75 ancestors in all, the oldest K821150 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 6 generations between
- 3 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 2 generations backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- 1 generation backK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
- This deviceK190012 OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. · 2019
Show all 10 generations
- Root · 10 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 9 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 8 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 7 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 6 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 5 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 4 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 3 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 2 generations backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- 1 generation backK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
- This deviceK190012 OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −9 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −8 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −7 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −6 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −5 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −4 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −3 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −2 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| −1 | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2010 | — |
| 0 (this device) | K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetSummary page 6…Dressing, Wound, Drug Classification: Unclassified 5-1c Predicate Device 510(K) number K093519 – CELOX Vascular Reference Device 510(K) number K110386 – CELOX Rapid Z-Fold Gauze Device Description: OMNI-STAT Vascular Rap… | 2010 |
| † | K110386 | Celox Rapid Gauze | 2011 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 75 ancestors have a recall of any class.
- 1 other device also cites its predicate K093519.
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. 2019, 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?
OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French
CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190012: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190012
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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