510(k) · Cleared

Cleared

Hemohalt Hemostasis Pad

K060409510(k) TraditionalCleared May 17, 200690-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vanson-Halosource, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Cleared on May 17, 2006 after a 90-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided: May 17, 2006
Review: 90 days
Class: Class U
Product code: QSY
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK060409 Hemohalt Hemostasis PadVanson-Halosource, Inc. · 2006
Descendant · cites it directly · 1 of its ownK120782 Interventional Hemostatic BandageZ-Medica Corporation · 2013
Descendant · 2 generations on · 0 of its ownK181641 QuikClot RadialZ-Medica, LLC · 2018

Most influential descendants

Showing 2 of 2 · See all

K120782Interventional Hemostatic BandageZ-Medica Corporation · 2013 · cites it directly1descendant
K181641QuikClot RadialZ-Medica, LLC · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K060409	Hemohalt Hemostasis Pad	Vanson-Halosource, Inc.	2006	—
+1	K120782	Interventional Hemostatic Bandage	Z-Medica Corporation	2013	—
+2	K181641	QuikClot Radial	Z-Medica, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2018	1	0

FIG. 1 — Lineage of K060409, 2006–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120782	Interventional Hemostatic Bandage	Z-Medica Corporation	2013	1

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?

Of its descendants, K120782 (Z-Medica Corporation, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All QSY devices

QSY 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

2007high 13 (2007) · low 1 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSY

142in 2024

2007high 586 (2023) · low 55 (2009)2026

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

2007high 14 (2025) · low 0 (2007)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	MAUDE reports
2007	13	63	0
2008	7	61	0
2009	9	55	0
2010	7	75	0
2011	8	137	0
2012	7	239	0
2013	3	161	0
2014	6	249	0
2015	6	171	0
2016	5	161	0
2017	1	—	0
2018	5	186	0
2019	4	336	0
2020	1	—	0
2021	1	—	0
2022	2	—	1
2023	7	586	0
2024	4	142	3
2025	2	—	14
2026	2	—	—

What is it indicated for?

The HemoHalt Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular percutaneous catheters and/or tubes; following hemodialysis procedures, treatments; for patients on anticoagulation therapy; and for lacerations, abrasions, and nose bleeds. For use only on external bleeding wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060409 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060409: Hemohalt Hemostasis Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060409

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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