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 2026-11-05, 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 1462 of 3531

510(k) clearances, page 1462 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030642	Deflecting Ureteral Access Sheath	Applied Medical Resources Corp	FED	Class II	2003-05-23
K030592	Gambro Polyflux, Model 140H, 170H, 210H	Gambro Renal Care Products	KDI	Class II	2003-05-23
K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221	Cardiacassist, Inc.	DQR	Class II	2003-05-23
K030230	Avita Bpm1 Series (Wrist Type) Blood Pressure Meter (or Monitor)	Avita Corporation	DXN	Class II	2003-05-23
K030039	Pathway Stm-10 Pelvic Floor Stimulator	The Prometheus Group	KPI	Class II	2003-05-23
K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models 774Xx, 775Xx, 776Xx, 777Xx, 788Xx,	Medtronic, Inc.	DWF	Class II	2003-05-22
K031469	Aquilion Super 4 Multislice CT Scanner, Model Tsx-101A/7	Toshiba America Medical Systems, In.C	JAK	Class II	2003-05-22
K031430	Cemex System Fast	Exactech, Inc.	LOD	Class II	2003-05-22
K031404	Dignity Ophthalmic Surgical System	Phacor Inc., A Santen Company	HQC	Class II	2003-05-22
K031388	Modification to Hypoguard Advance Blood Glucose Monitoring System	Arkray Factory USA, Inc.	CGA	Class II	2003-05-22
K031379	Dyonics Vision 325Z Dv3-Ccd Hermes Ready Camera System, Model 7209531	Smith & Nephew, Inc.	GCJ	Class II	2003-05-22
K031334	Texas T - Plate	Zimmer GmbH	HRS	Class II	2003-05-22
K031317	Smart 2940 D Er: Yag Laser	Cynosure, LLC	GEX	Class II	2003-05-22
K031292	Modification to Fossa Ureteral Stone Sweeper	Fossa Medical, Inc.	FAD	Class II	2003-05-22
K031274	Model 5071 Myocardial Pacing Lead	Medtronic, Inc.	DTB	Class III	2003-05-22
K031110	Apex Modular Acetabular Cup	VQ Orthocare	LPH	Class II	2003-05-22
K031046	Thermacool Tc System	Solta Medical, Inc.	GEI	Class II	2003-05-22
K030845	Coaguchek Pt.s Test for Prothrombin Time Self-Testing	Roche Diagnostics GmbH	GJS	Class II	2003-05-22
K030835	'Rapid One' - Propoxyphene Test	American Bio Medica Corp.	JXN	Class II	2003-05-22
K030649	Dri Cotinine Eia Assay	Microgenics Corporation	MRS	Class I	2003-05-22
K030623	Smith & Nephew Profix Total Knee System	Smith & Nephew, Inc.	MBH	Class II	2003-05-22
K023823	Easycup	Zer Hitech	JHI	Class II	2003-05-22
K023566	Codman Isocool Bipolar Forceps	Cerenovus, Inc.	GEI	Class II	2003-05-22
K022211	Hls Uni Evolution Prosthesis	TORNIER Inc.	HSX	Class II	2003-05-22
K020738	Avita Bf1 (Vitalio) Body Fat Analyzer	Avita Corporation	MNW	Class II	2003-05-22
K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	MQB	Class II	2003-05-21
K031206	Radiomed Soft Tissue Marker	Radiomed Corporation	JAK	Class II	2003-05-21
K031184	Cool Touch 3	New Star Lasers, Inc.	GEX	Class II	2003-05-21
K031082	Everest Bipolar L Hook & Pk Bipolar L Hook	Gyrus ACMI, Inc.	GEI	Class II	2003-05-21
K031081	Everest Lp Bipolar Scissors and Gyrus Lp Bipolar Scissors	Gyrus ACMI, Inc.	GEI	Class II	2003-05-21
K031079	Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode	Gyrus ACMI, Inc.	GEI	Class II	2003-05-21
K031034	Spin Down Rapidflap	Biomet Microfixation	GXN	Class II	2003-05-21
K031020	Flexiskin Latex Examination Gloves, Powdered, Non Sterile	Pt. Mandiri Inti Buana	LYY	Class I	2003-05-21
K031001	Acmi Vista Ctr Bipolar Loop Electrode	Acmi Corporation	FAS	Class II	2003-05-21
K030828	Tetracxp System (Software and System Guide)	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2003-05-21
K030812	Datex-Ohmeda S/5 Anesthesia Monitor with L-An03 and L-Ane03a Software	GE Healthcare	MHX	Class II	2003-05-21
K030805	Mythos 500	Msq (M2), Ltd.	GEX	Class II	2003-05-21
K030617	Pt2 Guide Wire and Addwire Extension Wire	Boston Scientific Corporation	DQX	Class II	2003-05-21
K030589	Modification to Numed Tyshak II and Z-Med II Ptv Catheters	Numed Inc	DQY	Class II	2003-05-21
K030576	Anspach Irrigation Pump and Irrigation Pump II	The Anspach Effort, Inc.	FRN	Class II	2003-05-21
K030558	Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray	Proxima Therapeutics, Inc.	JAQ	Class II	2003-05-21
K030544	Rfx Fluroscopic Digital Imaging System	Sigma Vision, Inc.	OWB	Class II	2003-05-21
K030534	Variseed 7.1	Varian Medical Systems, Inc.	KXK	Class II	2003-05-21
K031407	Ross Embrace Enteral Pump	Ross Product Div. Abbott Laboratories	LZH	Class II	2003-05-20
K031398	Is-1 Hemostasis Valve, Model 6799	Boston Scientific Corporation	DTL	Class II	2003-05-20
K031272	C.t.m. Mobility Scooter, Model Hs-120	C.T.M. Homecare Product, Inc.	INI	Class II	2003-05-20
K031134	Disposable Powdered Vinyl Exam Gloves	Elite International, Inc.	LYZ	Class I	2003-05-20
K031053	Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7	Spectramed, LLC	EGJ	Class II	2003-05-20
K030820	Everstick Post	Stick Tech Ltd.	ELR	Class I	2003-05-20
K030554	Callos	Skeletal Kinetics, LLC	MQV	Class II	2003-05-20