510(k) · Cleared
ClearedQuikclot Inteventional, Model P/N 182
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 Apr 8, 2009 as substantially equivalent to K072474 (Z-Medica Corporation, 2007) and 2 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 8, 2009
- Review
- 30 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K953781 (1995). 71 ancestors in all, the oldest K821150 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 7 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 6 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 5 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 4 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 3 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 2 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 1 generation backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- This deviceK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · cites it directly · 2 of its ownK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK120782 Interventional Hemostatic BandageZ-Medica Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK190012 OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK181641 QuikClot RadialZ-Medica, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK172155 StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010 · cites it directly2descendants
- K120782Interventional Hemostatic BandageZ-Medica Corporation · 2013 · cites it directly1descendant
- K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd. · 2019 · 2 generations on0descendants
- K181641QuikClot RadialZ-Medica, LLC · 2018 · 2 generations on0descendants
- K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −7 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −6 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −5 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −4 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −3 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −2 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −1 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| 0 (this device) | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +1 | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2010 | — |
| +1 | K120782 | Interventional Hemostatic Bandage | Z-Medica Corporation | 2013 | — |
| +2 | K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019 | — |
| +2 | K181641 | QuikClot Radial | Z-Medica, LLC | 2018 | — |
| +2 | K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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 15.0 · 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 |
|---|---|---|---|
| * | K072474 | Quikclot EXSummary page 5…General and Plastic Surgery Classification Name: Dressing Classification Code: FRO Predicate Device(s): QuikClot® eXTM (K072474) D-Stat Dry TM Hemostatic Bandage (K061219) ChitoFlex-Sur… | 2007 |
| * | K061219 | D-Stat Dry Hemostatic BandageSummary page 5…Classification Code: FRO Predicate Device(s): QuikClot® eXTM (K072474) D-Stat Dry TM Hemostatic Bandage (K061219) ChitoFlex-Surgical dressing (KO80818) Submitted By: Ronald E. Peterson… | 2006 |
| * | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | 2008 |
| † | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)… | 1997 |
What descends from it? (5)
2 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 14 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 71 ancestors have a recall of any class.
- Of its descendants, K093519 (Medtrade Products, Ltd., 2010) has gone furthest, with 2 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. 2009, 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® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090620: Quikclot Inteventional, Model P/N 182.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090620
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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