QSY

FDA Product Code QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

To Temporarily Control Bleeding And Cover External Wounds.

Leading manufacturers include Advamedica, Inc., Gel-E, Inc. and Cresilon, Inc..

127
Total
127
Cleared
176d
Avg days
1990
Since
Declining activity - 4 submissions in the last 2 years vs 11 in the prior period
Review times increasing: avg 208d recently vs 175d historically

FDA 510(k) Cleared Hemostatic Wound Dressing Without Thrombin Or Other Biologics Devices (Product Code QSY)

127 devices
1–24 of 127
Cleared Apr 30, 2026
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017
Lifescience Plus, Inc.
General & Plastic Surgery · 223d
Cleared Feb 26, 2026
Ganymede 2cm diameter (FG100300)
K251700
Speciality Fibres and Materials Limited
General & Plastic Surgery · 269d
Cleared Dec 15, 2025
MFUSE (MS001)
K250319
Machina Medical, Inc.
General & Plastic Surgery · 314d
Cleared Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609
Cresilon, Inc.
General & Plastic Surgery · 24d
Cleared Aug 14, 2024
TRAUMAGEL®
K240713
Cresilon, Inc.
General & Plastic Surgery · 152d
Cleared May 22, 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097
Ushare Medical, Inc.
General & Plastic Surgery · 131d
Cleared Apr 19, 2024
Hemoblock_S (Prescription)
K232216
Incore Co., Ltd.
General & Plastic Surgery · 268d
Cleared Mar 15, 2024
RESPONDER® Polysaccharide Hemostat
K240454
Starch Medical, Inc.
General & Plastic Surgery · 29d
Cleared Dec 04, 2023
RESPONDER Polysaccharide Hemostat
K220525
Starch Medical, Inc.
General & Plastic Surgery · 649d
Cleared Nov 17, 2023
Celox Rapid X-Ray Gauze
K230589
Medtrade Products , Ltd.
General & Plastic Surgery · 260d
Cleared Sep 01, 2023
Hemostatic Dressing
K213413
Jiangsu Newvalue Medical Products Co., Ltd.
General & Plastic Surgery · 682d
Cleared Jun 28, 2023
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
K213652
Cresilon, Inc.
General & Plastic Surgery · 586d
Cleared May 02, 2023
Zeolite Hemostatic Cotton
K223495
Hangzhou Zeo-Innov Life Technology Co., Ltd.
General & Plastic Surgery · 162d
Cleared Apr 07, 2023
Axiostat Gauze
K222909
Advamedica, Inc.
General & Plastic Surgery · 193d
Cleared Feb 02, 2023
S.E.A.L. Hemostatic Wound Spray
K210751
Bc3 Technologies, Inc.
General & Plastic Surgery · 692d
Cleared Jul 29, 2022
Vascette HP (hemostatic pad)
K220566
Koag, LLC
General & Plastic Surgery · 151d
Cleared Feb 10, 2022
Zeolite Hemostatic Gauze
K211570
Hangzhou Zeo-Innov Life Technology Co., Ltd.
General & Plastic Surgery · 265d
Cleared Apr 15, 2021
Axiostat Patch
K202830
Advamedica, Inc.
General & Plastic Surgery · 202d
Cleared Aug 28, 2020
Hemostatic Xerogel Sponge
K192671
Solaplus Biotech Co., Ltd.
General & Plastic Surgery · 337d
Cleared Dec 18, 2019
OMNI-STAT Vascular (Rapid)
K190012
Medtrade Product, Ltd.
General & Plastic Surgery · 349d
Cleared Dec 02, 2019
NasalCEASE and BleedCEASE
K183622
Les Laboratoires Brothier S.A.
General & Plastic Surgery · 341d
Cleared Oct 25, 2019
gel-e Flex+ gel OTC
K192667
Gel-E, Inc.
General & Plastic Surgery · 30d
Cleared Aug 29, 2019
gel-e Flex+
K182811
Gel-E, Inc.
General & Plastic Surgery · 330d
Cleared Dec 24, 2018
QuikClot Radial
K181641
Z-Medica, LLC
General & Plastic Surgery · 186d

About Product Code QSY - Regulatory Context

510(k) Submission Activity

127 total 510(k) submissions under product code QSY since 1990, with 127 receiving FDA clearance (average review time: 176 days).

Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 11 in the prior period.

FDA 510(k) Review Time - QSY Product Code

Recent submissions under QSY have taken an average of 208 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

QSY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →