510(k) · Cleared
Recalled · Class II · 2017Quikclot Hemostatic Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Medica, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Apr 12, 2013 as substantially equivalent to K072474 (Z-Medica Corporation, 2007) and 1 other predicate after a 161-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2013
- Review
- 161 days
- Class
- Class U
- Product code
- QSY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002550 (2000). 15 ancestors in all, the oldest K821150 (1982). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 4 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 3 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 2 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 1 generation backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- This deviceK123387 Quikclot Hemostatic DressingZ-Medica, LLC · 2013
- Descendant · cites it directly · 0 of its ownK253017 BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251700 Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400)…Speciality Fibres and Materials Limited · 2026
- Descendant · cites it directly · 0 of its ownK151204 HEMO-BandageCoreleader Biotech Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc. · 2026 · cites it directly0descendants
- K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited · 2026 · cites it directly0descendants
- K151204HEMO-BandageCoreleader Biotech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −5 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −4 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −3 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −2 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| 0 (this device) | K123387 | Quikclot Hemostatic Dressing | Z-Medica, LLC | 2013 | — |
| +1 | K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026 | — |
| +1 | K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm… | Speciality Fibres and Materials Limited | 2026 | — |
| +1 | K151204 | HEMO-Bandage | Coreleader Biotech Co., Ltd. | 2015 | — |
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 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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? (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 |
|---|---|---|---|
| * | K072474 | Quikclot EXSummary page 5…Classification: Unclassified Classification Narbie: Dressing Product Code: FRO 3. PREDICATE DEVICES * K072474 QuikClot® eX (also marketed as QuikClot Combat Gauze) * K071519 I-emCon Chito~lex Surgical Dressing 4. DEVICE… | 2007 |
| * | K071519 | Hemcon Chitoflex-Surgical DressingSummary page 5…ie: Dressing Product Code: FRO 3. PREDICATE DEVICES * K072474 QuikClot® eX (also marketed as QuikClot Combat Gauze) * K071519 I-emCon Chito~lex Surgical Dressing 4. DEVICE DESCRIPTION The purpose of this 510(k) is to obtain a new indica… | 2007 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2017 | Class II | Z-0925-2018 | Mixed-up of materials/components | A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer… |
| May 17, 2017 | Class II | Z-2612-2017 | Packaging process control | Packaging breach may compromise sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K253017 (Lifescience Plus, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K072474.
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. 2013, 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® Hemostatic Dressing is intended for use as a topical dressing for local
management of bleeding Wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical
wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123387: Quikclot Hemostatic Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123387
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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