510(k) · Cleared
ClearedCelox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze AG, Omni-Stat Hemostatic Anti
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 Dec 8, 2010 as substantially equivalent to K100693 (Medtrade Products Limited, 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Dec 8, 2010
- Review
- 64 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K002550 (2000). 36 ancestors in all, the oldest K821150 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 7 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 6 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 5 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 4 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 3 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 2 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 1 generation backK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- This deviceK102965 Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze…Medtrade Products, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −7 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −6 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −5 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −4 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −3 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −2 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| −1 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| 0 (this device) | K102965 | Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat… | Medtrade Products, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K100693 | Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingSummary page 5…ibacterial Trauma Gauze Classification Name: Dressing, Wound, Drug 3. Predicate Device: AQUANOVA Ag K(100693 (Medtrade Products) CELOX Trauma Gauze K(0917953 (Medtrade Products) CELOX A… | 2010 |
| * | K091795 | Medtrade Products Celox Trauma GauzeSummary page 5…Dressing, Wound, Drug 3. Predicate Device: AQUANOVA Ag K(100693 (Medtrade Products) CELOX Trauma Gauze K(0917953 (Medtrade Products) CELOX Antibacterial Trauma Gauze is substantially equivalent in raw materials and manufacturing… | 2009 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 36 ancestors have a recall of any class.
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 Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102965: Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze AG, Omni-Stat Hemostatic Anti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102965
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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