510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2467 of 3531

510(k) clearances, page 2467 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904457	Dial-Away Pain	R.F.P., Inc.	GZJ	Class II	1991-04-03
K904456	Cytomegalovirus (Cmv) Elisa	Virotech, Inc.	LFZ	Class II	1991-04-03
K903894	Venapulse Models Vp-25 and Vp-50	Aci Medical, LLC	JOW	Class II	1991-04-03
K902974	Cooling Teethers	Realgrow Intl. Corp.	KKO	Class II	1991-04-03
K902018	Dentaurum Ceramic Debonding Unit	Dentauraum, Inc.	EKS	Class I	1991-04-03
K910944	Medifil	Biocore	KGN	Unclassified	1991-04-02
K910931	Biliary Balloon Dilatation Catheter	Boston Scientific Corporation	FGE	Class II	1991-04-02
K910783	Shampaine Model 3800 or Muranaka Model or-604M	Smith & Nephew Equipment Group	BWN	Class I	1991-04-02
K910735	Hexidis Alcohol Swab	Specialites Septodont	LKB	Unclassified	1991-04-02
K910497	Wilson Cook Wire Guide and Protective Guide	Wilson-Cook Medical Inc.	OCY	Class II	1991-04-02
K910285	Browne Medical Syst.inc Stand-Alone Water Pump	Browne Medical Systems, Inc.	FAP	Class II	1991-04-02
K910217	Minipro 8100 Urodynamic Measureing System	Browne Medical Systems, Inc.	FAP	Class II	1991-04-02
K910022	Mmg/o'neil Urinary Catheterization System Kit	Medical Marketing Group	FCM	Class II	1991-04-02
K910015	Cannula Introduction Set	Lazarus Medical, Inc.	HET	Class II	1991-04-02
K905514	Autogenesis(tm) Automator	Advanced Biosearch Assn.	KTT	Class II	1991-04-02
K905269	Ochsner 500 Vascular Prosthesis	Intervascular, Inc.	DSY	Class II	1991-04-02
K905052	Bivona Endotracheal Tube Stylet	Bivona Medical Technologies	BSR	Class I	1991-04-02
K904508	Condor Analog Inflation Syringe	Professional Medical Services	MAV	Class II	1991-04-02
K902227	Serim Glutaraldehyde/nephrex Potency Test Kit	Serim Research Corp.	LIF	Class II	1991-04-02
K910975	Tekdyne Micro Retractor	Tekdyne	GAD	Class I	1991-04-01
K910946	Clearview Hcg	Unipath, Ltd.	JHJ	Class II	1991-04-01
K910906	Centurion Kleen-Needle System i.v. Extension Sets	Centurion Medical Products, LP	FPK	Class II	1991-04-01
K910897	Precise Flexistapler Circular Stapler, Series 398X	3M Medical Products Group	GDW	Class II	1991-04-01
K910866	Vascusoft (Vp1200k) Knitted Vascular Prosthesis	Vascutek, Ltd.	DSY	Class II	1991-04-01
K910865	Triaxil (Vp50k) Knitted Vascular Prosthesis	Vascutek, Ltd.	DSY	Class II	1991-04-01
K910864	Externally Reinforced Triaxial Prosthesis	Vascutek, Ltd.	DSY	Class II	1991-04-01
K910863	Extra Soft/extra Low Woven Vascular Prothesis	Vascutek, Ltd.	DSY	Class II	1991-04-01
K910728	Cleanflow System	Mitron Technologies, Inc.	KQT	Class II	1991-04-01
K910709	Weevac Tc Hand Carried Rescue Stretcher	W. Murphy Ent., Inc.	FPP	Class I	1991-04-01
K910623	Gauze Sponges Absorbent Gauze Rolls	Liaoning-Usa Corp.	EFQ	Unclassified	1991-04-01
K910621	Blades for Spinal Laminectomy Retractor	International Hospital Supply Co.	GZT	Class II	1991-04-01
K910519	Good Vibrations Tube Massager	Dual Voltage, Inc.	ISA	Class I	1991-04-01
K910425	Large Volume Elastomeric Infusion Device Attach.	Baxter Healthcare Corporation	FRN	Class II	1991-04-01
K910262	Keller Vital Signs Monitor - Kms-890	Keller Medical Specialties Products, Inc.	DSJ	Class II	1991-04-01
K910208	Baxter Marathon(r) Intravascular Guiding Catheters	Baxter Healthcare Corporation	DQO	Class II	1991-04-01
K910083	Omnifit Total Knee Bone Augmentation Wedges	Osteonics Corp.	HSX	Class II	1991-04-01
K905688	Cutinova Hydro	Beiersdorf, Inc.	KOZ	Class I	1991-04-01
K905586	Rsvp RF-2000	Tactilitics, Inc.	KMI	Class I	1991-04-01
K905447	E-Z-Em Pulsed Infusion System	E-Z-EM, Inc	KRA	Class II	1991-04-01
K905438	Normlgel Protective Wound Gel	Scott Health Care	FRO	Unclassified	1991-04-01
K905148	Temperature Probe	Tec II Medical, Inc.	CAI	Class I	1991-04-01
K905014	Amset Pld System	Advanced Med/Surg, Inc.	HRX	Class II	1991-04-01
K904718	Aero-Gen Nubulizer System	Tri/Bor Medical, Inc.	CAF	Class II	1991-04-01
K904717	Micro-Vent Nebulizer System	Tri/Bor Medical, Inc.	CAF	Class II	1991-04-01
K904475	Entree Sheath Introducer System	Cordis US Corp.	DYB	Class II	1991-04-01
K904208	Kinemax Superstabilizer Total Knee System	Howmedica Corp.	JWH	Class II	1991-04-01
K911247	Yours Truly Asymmetrical Breast Form	Jobst Institute, Inc.	KCZ	Class I	1991-03-29
K911180	Claw (5Mm/10mm) Atraumatic Grasp/micro Forceps	Northgate Technologies Inc.	HTD	Class I	1991-03-29
K911159	Palpation Probe	Northgate Technologies Inc.	GEN	Class I	1991-03-29
K911158	Micro Scissors, 5Mm Curve Micro Scissors, 5Mm	Northgate Technologies Inc.	LRW	Class I	1991-03-29