510(k) · Cleared
ClearedMedtrade Products Celox Vascular Topical Hemostatic Granules on Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jan 14, 2010 as substantially equivalent to K080097 (Medtrade Products, Ltd., 2008) and 3 other predicates after a 62-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 14, 2010
- Review
- 62 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K953781 (1995). 74 ancestors in all, the oldest K821150 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 5 generations between
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- This deviceK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK190012 OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK172155 StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018
Show all 9 generations
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 8 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 7 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 6 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 5 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 4 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- This deviceK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
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 |
|---|---|---|---|---|---|
| −9 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −8 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −7 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −6 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −5 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −4 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −3 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −2 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −1 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| 0 (this device) | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2010 | — |
| +1 | K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019 | — |
| +1 | K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 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 15.1 · 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? (4)
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 |
|---|---|---|---|
| * | K080097 | Medtrade Products Celox Hemostatic Granules on SheetSummary page 5…Dressing Classification Code: FRO Predicate Devices: CELOX Hemostatic Granules on Sheet (K(080097) Quik~lot Interventional hemostatic bandage (K(090620)… | 2008 |
| * | K090620 | Quikclot Inteventional, Model P/N 182Summary page 5…in indications for use and technologyrto the predicate devies&CELOX Hemostatic Granules on Sheet (KO080097) QuikClot Interventional hemostatic bandage (K090620) D-Stat Dry Hemostatic Bandage (K061219).and ChitoFlex-Surgical dressing (K(080818) Medtrade Products Ltd E… | 2009 |
| * | K061219 | D-Stat Dry Hemostatic BandageSummary page 5…ies&CELOX Hemostatic Granules on Sheet (KO080097) QuikClot Interventional hemostatic bandage (K090620) D-Stat Dry Hemostatic Bandage (K061219).and ChitoFlex-Surgical dressing (K(080818) Medtrade Products Ltd Electra House. Crewe Business Park, Crewe, Cheshire CW1I 60… | 2006 |
| * | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingSummary page 5…les on Sheet (KO080097) QuikClot Interventional hemostatic bandage (K090620) D-Stat Dry Hemostatic Bandage (K061219).and ChitoFlex-Surgical dressing (K(080818) Medtrade Products Ltd Electra House. Crewe Business Park, Crewe, Cheshire CW1I 60L ' 0 A T: +44… | 2008 |
| † | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)… | 1997 |
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 15 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 3 of the 74 ancestors have a recall of any class.
- Of its descendants, K190012 (Medtrade Product, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K080097.
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. 2010, 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?
CELOX Vascular is indicated for the local management and control of surface bleeding from
vascular access sites, percutaneous catheters. or tubes utilizing introducer sheaths up to
18French"
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093519: Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093519
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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