510(k) · Cleared
ClearedQuikclot Sport and Quikclot Sport Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Medica Corporation · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jan 25, 2007 as substantially equivalent to K021581 (On Site Gas Systems, Inc., 2002) and 2 other predicates after a 22-day review. Its family tree reaches back 4 generations to 2000. 38 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 22 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002550 (2000). 6 ancestors in all, the oldest K965034 (1998). 38 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 3 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 2 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 1 generation backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- This deviceK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- Descendant · cites it directly · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · 3 generations on · 10 of its ownK092357 Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009
- Descendant · 3 generations on · 9 of its ownK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K072474Quikclot EXZ-Medica Corporation · 2007 · cites it directly36descendants
- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · 2 generations on20descendants
- K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009 · 3 generations on10descendants
- K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010 · 3 generations on9descendants
- K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −3 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −2 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −1 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| 0 (this device) | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| +1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +2 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +3 | K092357 | Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4… | Hem Con Medical Technologies, Inc. | 2009 | — |
| +3 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| +3 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K021581 | HemosorbSummary page 5…Dressing Classification Code: FRO/ 0taJCV( S,; - Predicate Device: HemosorbTM Granular Hemostatic Agent (K021581) QuikClot 1st ResponseM Hemostatic Agent (K061767) Submitted By:… | 2002 |
| * | K061767 | Quikclot 1ST Response & Quikclot Acs+Summary page 5…Predicate Device: HemosorbTM Granular Hemostatic Agent (K021581) QuikClot 1st ResponseM Hemostatic Agent (K061767) Submitted By: Dr. Giacomo Basadonna, M.D., Ph.D. Company Name: Z-Med… | 2006 |
| * | K013390 | QuickclotSummary page 6…kClot Sport Silver TM contain the same zeolite technology that Z-Medica Corporation has incorporated into previous QuikClot® brand hemostatic agents, granular QuikClot® (K013390/K021581) and QuikClot ACST " (K051955), but this product uses zeolite that has been reformulated to reduce the heat of adsorption… | 2002 |
| † | K051955 | Quickclot Acs - Accelerated Clotting Sponge | 2005 |
What descends from it? (38)
See all 382 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 7 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K072474 (Z-Medica Corporation, 2007) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K021581.
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. 2007, 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?
QuikClot Sport & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070010: Quikclot Sport and Quikclot Sport Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070010
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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