510(k) · Cleared
ClearedMedtrade Products Celox Trauma Gauze
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 Nov 20, 2009 as substantially equivalent to K080097 (Medtrade Products, Ltd., 2008) and 1 other predicate after a 156-day review. Its family tree reaches back 7 generations to 2000. 7 later devices descend from it.
- Decided
- Nov 20, 2009
- Review
- 156 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002550 (2000). 18 ancestors in all, the oldest K821150 (1982). 7 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 6 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 5 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 4 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 3 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 2 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 1 generation backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- This deviceK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- Descendant · cites it directly · 5 of its ownK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
- Descendant · 2 generations on · 2 of its ownK143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze…Benq Materials Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK232216 Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK222909 Axiostat GauzeAdvamedica, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK172155 StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · cites it directly5descendants
- K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation · 2015 · 2 generations on2descendants
- K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd. · 2024 · 2 generations on0descendants
- K222909Axiostat GauzeAdvamedica, Inc. · 2023 · 3 generations on0descendants
- K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −6 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −5 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −4 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −3 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −2 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −1 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| 0 (this device) | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| +1 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| +2 | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze… | Benq Materials Corporation | 2015 | — |
| +2 | K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024 | — |
| +3 | K222909 | Axiostat Gauze | Advamedica, Inc. | 2023 | — |
| +3 | 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 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 15.0 · 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? (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 |
|---|---|---|---|
| * | K080097 | Medtrade Products Celox Hemostatic Granules on SheetSummary page 6…Classification Name: Dressing, Unclassified Predicate Device MedTrade Products Limited: CELOX Hemostatic Granules On Sheet (K080097) HemCon: ChitoGauze (K090026) Device Description CELOX Trauma Gauze Rx & OTC is ident… | 2008 |
| * | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266Summary page 6…g, Unclassified Predicate Device MedTrade Products Limited: CELOX Hemostatic Granules On Sheet (K080097) HemCon: ChitoGauze (K090026) Device Description CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorb… | 2009 |
| † | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | 2007 |
What descends from it? (7)
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 9 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K133121 (Sam Medical Products, 2014) has gone furthest, with 5 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. 2009, 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 Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091795: Medtrade Products Celox Trauma Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091795
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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