510(k) · Cleared
Recalled · Class II · 2021Quikclot EX
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 Oct 16, 2007 as substantially equivalent to K013390 (On Site Gas Systems, Inc., 2002) and 2 other predicates after a 42-day review. Its family tree reaches back 5 generations to 2000. 36 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2007
- Review
- 42 days
- Class
- Class U
- Product code
- QSY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K002550 (2000). 8 ancestors in all, the oldest K821150 (1982). 36 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 4 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 3 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 2 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 1 generation backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- This deviceK072474 Quikclot EXZ-Medica Corporation · 2007
- Descendant · cites it directly · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · 2 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 · 2 generations on · 9 of its ownK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- Descendant · 3 generations on · 5 of its ownK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · cites it directly20descendants
- 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 · 2 generations on10descendants
- K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010 · 2 generations on9descendants
- K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009 · 2 generations on7descendants
- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −4 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −3 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −2 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −1 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| 0 (this device) | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | — |
| +1 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +2 | 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 | — |
| +2 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| +2 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| +3 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 |
|---|---|---|---|
| * | K013390 | QuickclotSummary page 5…e Sponge Classification Name: Dressing Classification Code: FRO Predicate Device(s): QuikClot® Hemostatic Agent (K013390) QuikClot® SportTM (K070010) Nu Gauze® All Purpos… | 2002 |
| * | K070010 | Quikclot Sport and Quikclot Sport SilverSummary page 5…assification Code: FRO Predicate Device(s): QuikClot® Hemostatic Agent (K013390) QuikClot® SportTM (K070010) Nu Gauze® All Purpose Dressing (K821150) Submitted By: Ronald… | 2007 |
| * | K821150 | NU-Gauze SpongeSummary page 5…t® Hemostatic Agent (K013390) QuikClot® SportTM (K070010) Nu Gauze® All Purpose Dressing (K821150) Submitted By: Ronald E. Peterson, Dir. of Regulatory Affairs and QA Company Name:… | 1982 |
What descends from it? (36)
See all 368 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | 2009 | 20 |
| K090620 | Quikclot Inteventional, Model P/N 182 | 2009 | 5 |
| K123387 | Quikclot Hemostatic Dressing | 2013 | 3 |
| K211570 | Zeolite Hemostatic Gauze | 2022 | 1 |
| K180893 | IHM Technology Bandage | 2018 | 0 |
| K160130 | BloodSTOP iX Battle Matrix | 2016 | 0 |
| K101257 | Advanced Trauma Dressing (Atd) | 2011 | 0 |
| K080648 | Traumastat Rapid Hemostatic Wound Dressing Bandage | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2021 | Class II | Z-0211-2022 | Under Investigation by firm | Lack of Packaging seal integrity may result in a sterile barrier breach. |
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 11 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090026 (Hem Con Medical Technologies, Inc., 2009) has gone furthest, with 20 descendants of its own.
- 7 other devices also cite its predicate K013390.
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® eXTM is intended for temporary external use to control traumatic bleeding.
QuikClot® eXTM is 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/K072474 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072474: Quikclot EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072474
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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