510(k) · Cleared
ClearedUltraClot, UltraClot OTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergency Medical Devices, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Oct 9, 2008 as substantially equivalent to K013390 (On Site Gas Systems, Inc., 2002) and 5 other predicates after a 31-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Oct 9, 2008
- Review
- 31 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K002550 (2000). 40 ancestors in all, the oldest K821150 (1982). No later device cites it as a predicate yet.
- 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 deviceK082601 UltraClot, UltraClot OTCEmergency Medical Devices, LLC · 2008
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) | K082601 | UltraClot, UltraClot OTC | Emergency Medical Devices, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 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? (6)
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…d Dressing Device Class: Unclassified Product Code: FRO Predicate Device: QuikClot®, Z-Medica Corp., K013390 QuikClot® Sport, Z-Medica Corp, K070010 Description: Intended Use: UltraClo… | 2002 |
| * | K070010 | Quikclot Sport and Quikclot Sport SilverSummary page 5…Code: FRO Predicate Device: QuikClot®, Z-Medica Corp., K013390 QuikClot® Sport, Z-Medica Corp, K070010 Description: Intended Use: UltraClot is intended as a hemostatic dressing for… | 2007 |
| * | K081183 | WoundstatSummary page 6…UltraClot TM OTC as labeled in conformance with 21CFR 801 Subpart C is substantially equivalent in labeling to the aforementioned OTC predicate devices, Woundstat OTC (K081183), Quikclot Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K07021 1), and Blood… | 2008 |
| * | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Summary page 6…r legally marketed OTC wound management devices, including Woundstat® OTC (KOS1 183), Quikclot® Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K07021 1), and Bloodstop (KO71578). Conclusion: UltraClot TM is a safe and effective wound dressing which is at… | 2006 |
| * | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamSummary page 6…ound management devices, including Woundstat® OTC (KOS1 183), Quikclot® Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K07021 1), and Bloodstop (KO71578). Conclusion: UltraClot TM is a safe and effective wound dressing which is at least substantially equiv… | 2007 |
| * | K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27…Summary page 6…te devices, Woundstat OTC (K081183), Quikclot Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K07021 1), and Bloodstop (K071578). Emergency Medical Devices, LLC 510(k) UltraClot TM -4- Therefore,… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 40 ancestors has a recall.
- 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. 2008, 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?
Prescription, Rx
UltraClot is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding.
Over the Counter, OTC
UltraClot OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082601: UltraClot, UltraClot OTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082601
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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