510(k) · Cleared
ClearedInterventional Hemostatic Bandage
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 Mar 20, 2013 as substantially equivalent to K060409 (Vanson-Halosource, Inc., 2006) and 2 other predicates after a 370-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Mar 20, 2013
- Review
- 370 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K953781 (1995). 76 ancestors in all, the oldest K821150 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 5 generations between
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- This deviceK120782 Interventional Hemostatic BandageZ-Medica Corporation · 2013
- Descendant · cites it directly · 0 of its ownK181641 QuikClot RadialZ-Medica, LLC · 2018
Show all 9 generations
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 8 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 7 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 6 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 5 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 4 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- This deviceK120782 Interventional Hemostatic BandageZ-Medica Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K181641QuikClot RadialZ-Medica, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −8 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −7 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −6 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −5 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −4 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −3 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −2 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −1 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| 0 (this device) | K120782 | Interventional Hemostatic Bandage | Z-Medica Corporation | 2013 | — |
| +1 | K181641 | QuikClot Radial | Z-Medica, 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 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 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 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060409 | Hemohalt Hemostasis PadSummary page 5…ot lnterventional-A Hemostatic Bandage Common/Usual Name: Hemostatic Dressing Classification Name: Wound Dressing 3. PREDICATE DEVICES * K060409 HemoHalt Hemostasis Pad Wound Dressing * K] 12961 Scion Cardio-Vascular Clo-Sur PLUS * K040208 TZ Medical N… | 2006 |
| Kept off the family tree | K112961 | FDA’s K112961 is Clo-Surplus P.a.D. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandSummary page 5…und Dressing 3. PREDICATE DEVICES * K060409 HemoHalt Hemostasis Pad Wound Dressing * K] 12961 Scion Cardio-Vascular Clo-Sur PLUS * K040208 TZ Medical Neptune Pad and Comfort Band(lnterventional and Radial) * K090620 QuikClot Interventional Dressings 4.… | 2004 |
| * | K090620 | Quikclot Inteventional, Model P/N 182Summary page 5…nd Dressing * K] 12961 Scion Cardio-Vascular Clo-Sur PLUS * K040208 TZ Medical Neptune Pad and Comfort Band(lnterventional and Radial) * K090620 QuikClot Interventional Dressings 4. DEVICE DESCRIPTION The purpose of this 5 10(k) is to obtain a new indication fo… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181641 | QuikClot Radial | 2018 | 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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 76 ancestors have a recall of any class.
- Of its descendants, K181641 (Z-Medica, LLC, 2018) has gone furthest, with 0 descendants of its own.
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 [nterventional-A 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 7 Fr. in patients on drug/induced anti-coagulation treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120782: Interventional Hemostatic Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120782
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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