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 978 of 3531

510(k) clearances, page 978 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103838	Fixed Variable & Corpectomy Cervical Plate System	Precision Surgery, Ltd.	KWQ	Class II	2011-02-15
K103819	Psl Anterior Cervical Plate System	Precision Surgery, Ltd.	KWQ	Class II	2011-02-15
K103753	Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser	Sirona Dental Systems GmbH	GEX	Class II	2011-02-15
K103693	Vantage Abi	Summit Doppler Systems, Inc.	DXN	Class II	2011-02-15
K103517	Trabecular Metal Femoral Cone Augments	Zimmer Trabecular Metal Technology, Inc.	MBH	Class II	2011-02-15
K102763	Systems Integration	Olympus Medical Systems Corp.	ODA	Class II	2011-02-15
K102762	Orthostat Bone Hemostat Matrix Applicator	Orthocon, Inc.	MTJ	Unclassified	2011-02-15
K102366	Finess Endoscope	Entellus Medical, Inc.	EOB	Class II	2011-02-15
K102109	Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model Eu5011, Eu5012	Eurosets S.r.l.	DTZ	Class II	2011-02-15
K091207	Surgicraft Lockdown Acromioclavicular (Ac) Device	Surgicraft, Ltd.	HTN	Class II	2011-02-15
K103491	Skyline Anterior Cervical Plate System	A Johnson & Johnson Company	KWQ	Class II	2011-02-14
K103379	Telio Cs Inlay & Telio Cs Onlay	Ivoclar Vivadent, Inc.	EBG	Class II	2011-02-14
K103244	Qmix 2In1 Endodontic Irrigating Solution	Dentsply Intl.	KJJ	Unclassified	2011-02-14
K103084	Neodent Graft Screw	Jjgc Industria E Comercio de Materiais Dentarios S	DZL	Class II	2011-02-14
K102045	Dimension Visa Hba1c, Model K3105a	Siemens Heatlhcare Diagnostics, Inc.	LCP	Class II	2011-02-14
K100184	Fustar Steerable Introducers	Lifetech Scientific (Shenzhen) Co,.ltd	DQY	Class II	2011-02-14
K110157	Sysloc Mini V3	JMS North America Corp.	FIE	Class II	2011-02-11
K110134	Nc Trek Rx Coronary Dilatation Catheter	Abbott Vascular-Cardiac Therapies	LOX	Class II	2011-02-11
K110103	Edwards Lifesciences Left Atrial Pressure Monitor Catheter	Edwards Lifesciences LLC	DQO	Class II	2011-02-11
K110093	Superdimension Marker Delivery Kit	Medtronic, Inc.	JAK	Class II	2011-02-11
K103761	Visualize: Vascular	The Medipattern Corporation	LLZ	Class II	2011-02-11
K103386	Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher(r) Guide Catheters	Medtronic, Inc.	DQY	Class II	2011-02-11
K103352	Versafitcup Cc Trio	Medacta International SA	LZO	Class II	2011-02-11
K103346	Delikit Putty, Delikit Heavy Body, Delikit Light Body	Sherpa Korea	ELW	Class II	2011-02-11
K103345	Breathe Technologies Ventilator and Accessories (Bt-V2s)	Breathe Technologies, Inc.	ONZ	Class II	2011-02-11
K103330	Brivo Mr355, Optima Mr360	GE Hangwei Medical Systems, Co. Ltd	LNH	Class II	2011-02-11
K103238	1.5T Optima Mr430s	GE Healthcare	LNH	Class II	2011-02-11
K103171	Elecsys Anti-Tpo Calset	Roche Diagnostics GmbH	JIX	Class II	2011-02-11
K103000	Smart Read Biological Test Pack	Steritec Products Mfg. Co., Inc.	JOJ	Class II	2011-02-11
K102750	O2-in-a-Box, O2-in-a-Box	Geto2, Inc.	CAW	Class II	2011-02-11
K102714	Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils, Vortx -18, Vortx 35 & 2D Helical	Boston Scientific Corporation	KRD	Class II	2011-02-11
K102471	As3700 Anesthsia Delivery System	Datascope Corp.	BSZ	Class II	2011-02-11
K102449	Bright Spine Galileo Spinal Spacer System	Bright Spine	ODP	Class II	2011-02-11
K102321	Digital Flat Panel X-Ray Detector Model Sdx-4336Cp	Samsung Mobile Display Co., Ltd.	MQB	Class II	2011-02-11
K101818	4Cis Vane Spine System	Solco Biomedical Corp.	MNH	Class II	2011-02-11
K101160	Roche Oral Fluid Cocaine	Roche Diagnostics GmbH	DIO	Class II	2011-02-11
K100144	Thermo Scientific Qms Everolimus Reagents, Calibrators and Controls	Microgenics Corporation	OUF	Class II	2011-02-11
K093867	Roche Oral Fluid Opiates, Dat Qual Cal a, Dat Control Set a and Dat Sq Cal a	Roche Diagnostics GmbH	DJG	Class II	2011-02-11
K093745	One Touch Verio Blood Glucose Monitoring System	Lifescan, Inc.	NBW	Class II	2011-02-11
K110079	Spphine Plus Stm 3W Diode Laser	Den-Mat Holdings, LLC	GEX	Class II	2011-02-10
K110049	Reusable Linear Stapler Handle	Ethicon Endo-Surgery Inc	GDW	Class II	2011-02-10
K103564	Venofer Pump	Renal Solutions, Inc.	KDI	Class II	2011-02-10
K103553	Lifescan Onetouch Select / Ultra / Vita Glucose Control Solution	Bionostics, Inc.	JJX	Class I	2011-02-10
K103540	Psoria-Light	Psoria-Shield Inc	FTC	Class II	2011-02-10
K103242	Redsense-Alarm Unit and Sensor	Redsense Medical AB	ODX	Class II	2011-02-10
K103137	Venus Anterior Cervical Plate	Verticor, Ltd.	KWQ	Class II	2011-02-10
K103101	Hi-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	DQX	Class II	2011-02-10
K102738	Lanx Fusion System	Lanx, Inc.	OVD	Class II	2011-02-10
K102283	Zeus Scientific, Inc. Treponema Pallidum Igg Test System	Zeus Scientific LLC	LIP	Class II	2011-02-10
K101873	Masterscreen Ios	Carefusion Germany 234 GmbH	BZG	Class II	2011-02-10