510(k) · Cleared
ClearedQuickclot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On Site Gas Systems, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 23, 2002 as substantially equivalent to K002550 (Marine Polymer Technologies, Inc., 2000) after a 220-day review. Its family tree reaches back 1 generation to 2000. 64 later devices descend from it.
- Decided
- May 23, 2002
- Review
- 220 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002550 (2000). 64 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- This deviceK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- Descendant · 2 generations on · 39 of its ownK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- Descendant · cites it directly · 38 of its ownK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- Descendant · cites it directly · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · cites it directly · 27 of its ownK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K051955Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005 · cites it directly42descendants
- K061767Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006 · 2 generations on39descendants
- K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007 · cites it directly38descendants
- K072474Quikclot EXZ-Medica Corporation · 2007 · cites it directly36descendants
- K061079Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Medtrade Products, Ltd. · 2006 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| 0 (this device) | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| +1 | 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 | — |
| +1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +1 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K002550 | RDH BandageSummary page 6…Name QuikClot Device Class Class | Classification Panel General and Plastic Surgery Common Name Traumatic Wound Dressing Predicate Device RDH Bandage, 510(K) Nurmber-K002550 Submitted By Francis X. Hursey, President Company Name On Site Gas Systemns Company Address 35 Budney Road Newington, CT 06111… | 2000 |
What descends from it? (64)
See all 648 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051955 | Quickclot Acs - Accelerated Clotting Sponge | 2005 | 42 |
| K070010 | Quikclot Sport and Quikclot Sport Silver | 2007 | 38 |
| K072474 | Quikclot EX | 2007 | 36 |
| K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762… | 2006 | 27 |
| K080210 | Pro QR Advanced Formula Powder | 2009 | 16 |
| K071936 | Woundstat, Model TC1001 | 2007 | 3 |
| K082601 | UltraClot, UltraClot OTC | 2008 | 0 |
| K050769 | Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100G - 1.9MM - 2.4MM.… | 2005 | 0 |
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?
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.
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 is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe wounds.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013390: Quickclot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013390
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026