510(k) · Cleared
ClearedQuickclot Acs - Accelerated Clotting Sponge
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 Aug 10, 2005 as substantially equivalent to K013390 (On Site Gas Systems, Inc., 2002) after a 22-day review. Its family tree reaches back 2 generations to 2000. 42 later devices descend from it.
- Decided
- Aug 10, 2005
- Review
- 22 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002550 (2000). 42 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 1 generation backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- This deviceK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- Descendant · cites it directly · 39 of its ownK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- Descendant · 2 generations on · 38 of its ownK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- Descendant · 3 generations on · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · 4 generations on · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · 5 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
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K061767Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006 · cites it directly39descendants
- K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007 · 2 generations on38descendants
- K072474Quikclot EXZ-Medica Corporation · 2007 · 3 generations on36descendants
- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · 4 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 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −1 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| +1 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| +2 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| +3 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +4 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +5 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 4 | 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? (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 |
|---|---|---|---|
| * | K013390 | QuickclotSummary page 5…Classification Code: FRO Predicate Device: QuikClot® Brand Hemostatic Granules 510(k) No. K013390 Submitted By: Robert V. Packard, QA Manager Company Name: Z-Medica Corpor… | 2002 |
What descends from it? (42)
See all 423 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 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061767 (Z-Medica Corporation, 2006) has gone furthest, with 39 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.
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 ACS - "Advanced Clotting Sponge", is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051955: Quickclot Acs - Accelerated Clotting Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051955
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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