Product Code: QSY FDA unclassified

Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Unknown

The Hemostatic Wound Dressing Without Thrombin or Other Biologics is a wound dressing intended to temporarily control bleeding and provide coverage for external wounds using hemostatic mechanisms that do not involve biologic additives such as thrombin. Its classification is currently unclassified (pending formal classification determination), reviewed under the General and Plastic Surgery panel. The distinction from biologic-containing dressings influences its regulatory pathway. It is not an implant and not life-sustaining.

View on FDA

510(k)s

127

FEI Numbers

113

Registration Numbers

113

Unique Applicants

Years Active

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Basic Information

Product Code: QSY
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

To temporarily control bleeding and cover external wounds.

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 127 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253017	BloodSTOP iX Trauma Matrix (TM-iX-20)	Apr 30, 2026	Substantially Equivalent	Lifescience Plus, Inc.
K251700	Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm	Feb 26, 2026	Substantially Equivalent	Speciality Fibres and Materials Limited
K250319	MFUSE (MS001)	Dec 15, 2025	Substantially Equivalent	Machina Medical, Inc.
K253609	TRAUMAGEL® 2.0 Hemostatic Gel	Dec 12, 2025	Substantially Equivalent	Cresilon, Inc.
K240713	TRAUMAGEL®	Aug 14, 2024	Substantially Equivalent	Cresilon, Inc.
K240097	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)	May 22, 2024	Substantially Equivalent	Ushare Medical, Inc.
K232216	Hemoblock_S (Prescription); Hemoblock_S (OTC)	Apr 19, 2024	Substantially Equivalent	Incore Co., Ltd.
K240454	RESPONDER® Polysaccharide Hemostat	Mar 15, 2024	Substantially Equivalent	Starch Medical, Inc.
K220525	RESPONDER Polysaccharide Hemostat	Dec 04, 2023	Substantially Equivalent	Starch Medical, Inc.
K230589	Celox Rapid X-Ray Gauze	Nov 17, 2023	Substantially Equivalent	Medtrade Products , Ltd.
K213413	Hemostatic Dressing	Sep 01, 2023	Substantially Equivalent	Jiangsu Newvalue Medical Products Co., Ltd.
K213652	Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)	Jun 28, 2023	Substantially Equivalent	Cresilon, Inc.
K223495	Zeolite Hemostatic Cotton	May 02, 2023	Substantially Equivalent	Hangzhou Zeo-Innov Life Technology Co., Ltd.
K222909	Axiostat Gauze	Apr 07, 2023	Substantially Equivalent	Advamedica, Inc.
K210751	S.E.A.L. Hemostatic Wound Spray	Feb 02, 2023	Substantially Equivalent	Bc3 Technologies, Inc.
K220566	Vascette HP (hemostatic pad)	Jul 29, 2022	Substantially Equivalent	Koag, LLC
K211570	Zeolite Hemostatic Gauze	Feb 10, 2022	Substantially Equivalent	Hangzhou Zeo-Innov Life Technology Co., Ltd.
K202830	Axiostat Patch	Apr 15, 2021	Substantially Equivalent	Advamedica, Inc.
K192671	Hemostatic Xerogel Sponge	Aug 28, 2020	Substantially Equivalent	Solaplus Biotech Co., Ltd.
K190012	OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid	Dec 18, 2019	Substantially Equivalent	Medtrade Product, Ltd.
K183622	NasalCEASE and BleedCEASE	Dec 02, 2019	Substantially Equivalent	Les Laboratoires Brothier S.A.
K192667	gel-e Flex+ gel OTC	Oct 25, 2019	Substantially Equivalent	Gel-E, Inc.
K182811	gel-e Flex+	Aug 29, 2019	Substantially Equivalent	Gel-E, Inc.
K181641	QuikClot Radial	Dec 24, 2018	Substantially Equivalent	Z-Medica, LLC
K180893	IHM Technology Bandage	Sep 19, 2018	Substantially Equivalent	Protege Biomedical
K180152	gel-e Flex	Jun 22, 2018	Substantially Equivalent	Gel-E, Inc.
K172155	StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing	Apr 12, 2018	Substantially Equivalent	Statguard, LLC
K172324	Axiostat Chitosan Hemostatic Dressing	Feb 23, 2018	Substantially Equivalent	Advamedica, Inc.
K161274	Bondiloxs Topical Hemostatic Granules	Jan 18, 2017	Substantially Equivalent	Medtrade Products , Ltd.
K161013	InnoSEAL Hemostatic Pad	Nov 29, 2016	Substantially Equivalent	Innotherapy, Inc.
K160679	WoundClot9	Aug 08, 2016	Substantially Equivalent	Core Scientific Creation , Ltd.
K160578	Nustat XR	Jun 29, 2016	Substantially Equivalent	Beeken Biomedical, LLC
K160130	BloodSTOP iX Battle Matrix	Jun 29, 2016	Substantially Equivalent	Lifescience Plus, Inc.
K153582	Prometheus ChitoGauze XR PRO	May 25, 2016	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K150916	HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO	Nov 10, 2015	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K150963	AnsCare ChitoClot Pad	Nov 05, 2015	Substantially Equivalent	Benq Materials Corporation
K151204	HEMO-Bandage	Jul 31, 2015	Substantially Equivalent	Coreleader Biotech Co., Ltd.
K143466	Hemogrip Patch	Jun 08, 2015	Substantially Equivalent	Remedium Technologies, Inc.
K143462	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	May 08, 2015	Substantially Equivalent	Benq Materials Corporation
K142363	NUSTAT, NUSTAT XR	Jan 09, 2015	Substantially Equivalent	Beeken Biomedical
K140573	WOUNDCLOT HEMOSTATIC GAUZE	Nov 24, 2014	Substantially Equivalent	Core Scientific , Ltd.
K140313	STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM	Jul 28, 2014	Substantially Equivalent	Coag Medical, LLC
K140757	D2 HEMOSTANTIC DRESSING	Jul 17, 2014	Substantially Equivalent	Z-Medica, LLC
K132333	BONDILOXS TOPICAL HEMOSTATIC DRESSING	Jun 25, 2014	Substantially Equivalent	Medtrade Products , Ltd.
K133121	CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT	May 22, 2014	Substantially Equivalent	Sam Medical Products
K132105	PERCLOT TOPICAL	Apr 03, 2014	Substantially Equivalent	Cryolife, Inc.
K130324	STATSEAL DISC	Jul 09, 2013	Substantially Equivalent	Biolife, LLC
K123387	QUIKCLOT HEMOSTATIC DRESSING	Apr 12, 2013	Substantially Equivalent	Z-Medica, LLC
K120782	INTERVENTIONAL HEMOSTATIC BANDAGE	Mar 20, 2013	Substantially Equivalent	Z-Medica Corporation
K122886	NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING	Nov 15, 2012	Substantially Equivalent	Hemostasis, LLC
K121485	GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING	Aug 21, 2012	Substantially Equivalent	Hemcon Medical Technologies Europe, Ltd.
K112864	SOFTSEAL-C	Aug 02, 2012	Substantially Equivalent	Chitogen, Inc.
K113560	CELOX GAUZE PRO	Aug 01, 2012	Substantially Equivalent	Medtrade Products , Ltd.
K120958	POSISEP AND POSISEP X HEMOSTAT DRESSINGS	Jul 25, 2012	Substantially Equivalent	Hemostasis, LLC
K112800	SUNTOUCH TOPICAL HEMOSTATIC DRESSING	May 23, 2012	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.
K112215	HEMCON HEMOSTATIC GEL	Apr 12, 2012	Substantially Equivalent	Hemcon Medical Technologies Europe, Ltd.
K101257	ADVANCED TRAUMA DRESSING (ATD)	Dec 01, 2011	Substantially Equivalent	Nanosys, Inc.
K112961	CLO-SURPLUS P.A.D.	Oct 31, 2011	Substantially Equivalent	Scion Cardio-Vascular, Inc.
K102944	CORELEADER HEMO-PAD MODEL CPII 02030	Sep 07, 2011	Substantially Equivalent	Coreleader Biotech Co., Ltd.
K103641	GUARDACARE	Jun 16, 2011	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K111163	CHITOGAUZE FUSION	May 17, 2011	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K110386	CELOX RAPID GAUZE	May 10, 2011	Substantially Equivalent	Medtrade Products , Ltd.
K103245	CELSTAT	Mar 23, 2011	Substantially Equivalent	Baxter Healthcare Corp
K102742	NASAL CEASE	Feb 02, 2011	Substantially Equivalent	Catalina, Inc.
K102965	CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI	Dec 08, 2010	Substantially Equivalent	Medtrade Products , Ltd.
K102459	NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE	Dec 03, 2010	Substantially Equivalent	Hemostasis, LLC
K102546	CHITOGAUZE	Nov 17, 2010	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K101097	CALGAESEAL MODEL: CAS	Sep 22, 2010	Substantially Equivalent	Bz Medical, Inc.
K093729	GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I	Jun 08, 2010	Substantially Equivalent	Hemcon Medical Technologies Europe, Ltd.
K093593	CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO	Jan 20, 2010	Substantially Equivalent	Medtrade Products Limited
K093519	MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET	Jan 14, 2010	Substantially Equivalent	Medtrade Products , Ltd.
K091795	MEDTRADE PRODUCTS CELOX TRAUMA GAUZE	Nov 20, 2009	Substantially Equivalent	Medtrade Products , Ltd.
K090780	MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE	Nov 20, 2009	Substantially Equivalent	Medtrade Products , Ltd.
K092552	CLO-SURPLUS P.A.D.	Sep 04, 2009	Substantially Equivalent	Scion Cardio-Vascular, Inc.
K092357	CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2	Aug 25, 2009	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K091194	ALGISEAL PAD	May 18, 2009	Substantially Equivalent	Evolution Medical Technologies, LLC
K090620	QUIKCLOT INTEVENTIONAL, MODEL P/N 182	Apr 08, 2009	Substantially Equivalent	Z-Medica Corporation
K090026	CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266	Mar 31, 2009	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K090100	SOFTSEAL-STF	Mar 11, 2009	Substantially Equivalent	Chitogen, Inc.
K080210	PRO QR ADVANCED FORMULA POWDER	Feb 10, 2009	Substantially Equivalent	Biolife, LLC
K080532	BENACEL, MODELS C-001, C-002 AND C-005	Nov 12, 2008	Substantially Equivalent	Unicare Biomedical, Inc.
K082601	UltraClot, UltraClot OTC	Oct 09, 2008	Substantially Equivalent	Emergency Medical Devices, LLC
K072486	MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC	Aug 06, 2008	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K080097	MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET	Jul 09, 2008	Substantially Equivalent	Medtrade Products , Ltd.
K081183	WOUNDSTAT	Jun 19, 2008	Substantially Equivalent	Traumacure, Inc.
K080818	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	May 15, 2008	Substantially Equivalent	Hem Con Medical Technologies, Inc.
K080648	TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE	May 07, 2008	Substantially Equivalent	Ore-Medix, LLC
K072328	MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT	Dec 21, 2007	Substantially Equivalent	Medtrade Products , Ltd.
K072890	STASILON FR	Dec 10, 2007	Substantially Equivalent	Entegrion, Inc.
K072681	BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE	Nov 02, 2007	Substantially Equivalent	Lifescience Plus, Inc.
K072900	EXCELARREST FOAM	Oct 26, 2007	Substantially Equivalent	Hemostasis, LLC
K070520	PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)	Oct 23, 2007	Substantially Equivalent	Biolife, LLC
K072474	QUIKCLOT EX	Oct 16, 2007	Substantially Equivalent	Z-Medica Corporation
K071578	BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17	Sep 27, 2007	Substantially Equivalent	Lifescience Plus, Inc.
K071936	WOUNDSTAT, MODEL TC1001	Aug 23, 2007	Substantially Equivalent	Traumacure, Inc.
K063190	SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC	Aug 21, 2007	Substantially Equivalent	Noble Fiber Technologies, Inc.
K071519	HEMCON CHITOFLEX-SURGICAL DRESSING	Aug 06, 2007	Substantially Equivalent	Hemcon, Inc.
K070175	AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC	Jul 25, 2007	Substantially Equivalent	Medtrade Products , Ltd.
K070211	TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM	Apr 05, 2007	Substantially Equivalent	Hemostasis, LLC
K070010	QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER	Jan 25, 2007	Substantially Equivalent	Z-Medica Corporation
K061722	BLOXX RAPID CLOTTING AGENT	Aug 02, 2006	Substantially Equivalent	Crosslink-D, Inc.
K061767	QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+	Jul 19, 2006	Substantially Equivalent	Z-Medica Corporation
K061079	MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES	Jun 02, 2006	Substantially Equivalent	Medtrade Products , Ltd.
K060409	HEMOHALT HEMOSTASIS PAD	May 17, 2006	Substantially Equivalent	Vanson-Halosource, Inc.
K051955	QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE	Aug 10, 2005	Substantially Equivalent	Z-Medica Corporation
K040283	BIOPAD	Jul 22, 2005	Substantially Equivalent	Euroresearch Srl
K043050	HEMCON BANDAGE AND HEMCON BANDAGE OTC	Jun 03, 2005	Substantially Equivalent	Hemcon, Inc.
K050769	QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172	Apr 14, 2005	Substantially Equivalent	Z-Medica Corporation
K040208	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	May 11, 2004	Substantially Equivalent	Tz Medical, Inc.
K033291	TOPSEAL HEMOSTATIC DRESSING, MODEL 11150	Mar 17, 2004	Substantially Equivalent	Radi Medical Systems AB
K032986	CLO-SURPLUSP.A.D.	Mar 01, 2004	Substantially Equivalent	Scion Cardio-Vascular, Inc.
K033666	HEMADERM	Dec 17, 2003	Substantially Equivalent	Medafor, Inc.
K030946	HEMCON BANDAGE OTC; HEMCON CATH/AID	Jun 19, 2003	Substantially Equivalent	Hemcon, Inc.
K030334	T-SCIENTIFIC T-PAD	Apr 21, 2003	Substantially Equivalent	T-Scientific, Inc.
K023298	HEMCON BANDAGE	Nov 04, 2002	Substantially Equivalent	Hemcon, Inc.
K021062	CHITO-SEAL	Aug 23, 2002	Substantially Equivalent	Abbott Vascular, Inc.
K021678	HEMADERM COTAINING HEMADEX CLOTTING BEADS	Jul 12, 2002	Substantially Equivalent	Medafor, Inc.
K021581	HEMOSORB	Jul 12, 2002	Substantially Equivalent	On Site Gas Systems, Inc.
K013390	QUICKCLOT	May 23, 2002	Substantially Equivalent	On Site Gas Systems, Inc.
K010933	SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY	Jan 08, 2002	Substantially Equivalent	Alltracel Pharma , Ltd.
K982638	3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214	Aug 21, 1998	Substantially Equivalent	Innovative Technologies , Ltd.
K965034	SORBASTACE	Apr 09, 1998	Substantially Equivalent for Some Indications	Hemostace, LLC
K910080	KALTOSTAT WOUND PACKING	Mar 20, 1991	Substantially Equivalent	Calgon Vestal Div.
K910059	KALTOSTAT WOUND DRESSING	Mar 20, 1991	Substantially Equivalent	Calgon Vestal Div.
K901564	SOLUSPONGE - S-99	Feb 27, 1991	Substantially Equivalent	Sie Medical Supply Co., Inc.
K904488	KALTOSTAT WOUND DRESSING	Dec 12, 1990	Substantially Equivalent for Some Indications	Calgon Vestal Div.
K893123	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	Feb 13, 1990	Substantially Equivalent	Les Laboratorires Brothier, S.A.