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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 906 of 3530

510(k) clearances, page 906 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120774	Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity Lt, Mobile Acuity, Mobile Lt	Welch Allyn Inc	DSI	Class II	2012-04-10
K120390	Solafix Twist Screw Implant System, Surgical Instrument Set	Solana Surgical, LLC	HWC	Class II	2012-04-10
K120157	Mini Maxlock Extreme Plating System	TORNIER Inc.	HRS	Class II	2012-04-10
K113608	Deflex	Nuxen S.r.l.	EBI	Class II	2012-04-10
K113548	Pedcat	CurveBeam, LLC	JAK	Class II	2012-04-10
K113466	Aquilion One	Toshiba Medical Systems Coporation, Japan	JAK	Class II	2012-04-10
K112989	Aquilion Cxl	Toshiba America Medical Systems, In.C	JAK	Class II	2012-04-10
K112110	Sterile Lubricating Jelly	Jianerkang Medical Dressing Company	KMJ	Class I	2012-04-10
K111924	Finesse Personal Insulin Delivery Patch	Calibra Medical, Inc.	OPP	Class II	2012-04-10
K120477	Aerosync for Aerodr System	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2012-04-09
K120473	Pixel App	Gauss Surgical, Inc.	LWH	Class I	2012-04-09
K120368	Capstone Control Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2012-04-09
K120349	Sonixgps Vascular Access Needle Kit	Ultrasonix Medical Corpation	DRE	Class II	2012-04-09
K112653	On Call Vivid Blood Glucose Monitoring Systems	Acon Laboratories, Inc.	JJX	Class I	2012-04-09
K112481	First Choice Druj System, Partial Head Implant	Ascension Orthopedic	KXE	Class II	2012-04-09
K112149	Weight and Body Fat Scale Shine Bs0105	Shine Overseas Marketing Limited	MNW	Class II	2012-04-09
K120721	Eos	EOS imaging	MQB	Class II	2012-04-06
K120710	Aquilion Prime	Toshibamedical Systems Corporation	JAK	Class II	2012-04-06
K120709	The Dome Gx4mp Color Nonitor	NDS Surgical Imaging, LLC	LLZ	Class II	2012-04-06
K120613	Oec 9900 Elite	GE Healthcare Surgery GE Oec Medical Systems, Inc.	OXO	Class II	2012-04-06
K120448	Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control	Apex Biotechnology Corp.	CGA	Class II	2012-04-06
K120388	Insight - Fd Mini C-Arm Fluoroscopic Imaging System	Hologic, Inc.	OXO	Class II	2012-04-06
K120387	Raystation	RaySearch Laboratories AB (publ)	MUJ	Class II	2012-04-06
K120361	Synapse 3D Base Tools	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2012-04-06
K120279	Nanofuse Dbm	Nanotherapeutics	MQV	Class II	2012-04-06
K120187	Multi-Modality Image Fusion	Igt, LLC dba Eigen	LLZ	Class II	2012-04-06
K120095	Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode with Hand Controls, S90 with Hand	DePuy Mitek, Inc.	GEI	Class II	2012-04-06
K113463	Power Wheelchair	Suzhou KD Medical Appliance Co., Ltd.	ITI	Class II	2012-04-06
K113170	Cervical Plate	Eisertech, LLC	KWQ	Class II	2012-04-06
K112899	Arthrex Bio-Suture	Arthrex GmbH	GAT	Class II	2012-04-06
K112505	Etherea	Regulatory Insight, Inc.	GEX	Class II	2012-04-06
K111997	Image1 Gi Ccu Model 22203020-114	Karl Storz Endoscopy-America, Inc.	FET	Class II	2012-04-06
K120828	Biatain Silicone Ag Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2012-04-05
K120697	Eagle Eye Platinum St Catheter	Volcano Corporation	OBJ	Class II	2012-04-05
K120570	Choice Spine Vertebral Body Replacement (Vbr) Device System	Choicespine, LP	MQP	Class II	2012-04-05
K120003	Nucal	Pulpdent Corporation	EJK	Class II	2012-04-05
K113677	Grindcare Measure	Medotech A/S	KZM	Class II	2012-04-05
K113674	Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare Handpiece Cleaner & Lubricant	Handpiece Headquarters, Inc. - Hpr, Inc.	EFB	Class I	2012-04-05
K113640	Stellar 150	Resmed Germany, Inc.	MNT	Class II	2012-04-05
K113626	Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/cardiotomy Reservoir	Corcym Inc.	DTZ	Class II	2012-04-05
K113554	Cmi Implant Is System	Neobiotech Co., Ltd.	DZE	Class II	2012-04-05
K113502	Advantage Laser System	Lutronic Corporation	GEX	Class II	2012-04-05
K112470	2Gc Hip/knee Modular Spacer	Mandell Horwitz Consultants, LLC	KWL	Class II	2012-04-05
K111453	Steam Dot Blu Process Indicator	Propper Mfg Co Inc	JOJ	Class II	2012-04-05
K110481	Triton Self Contained Dental System, Triton Self Contained Dental System, with Case	ASI Medical, Inc.	EIA	Class I	2012-04-05
K120686	Orbit Galaxy G2 Microcoil Delivery System	Cerenovus, Inc.	HCG	Class II	2012-04-04
K120674	Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter	Medtronic, Inc.	MPB	Class II	2012-04-04
K120667	Vlp 2.7Mm Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5Mm Anterior Ankle Fusion Plates, Peri-Loc 3.5Mm Hindfoot	Smith & Nephew, Inc.	HRS	Class II	2012-04-04
K120656	Everest Spinal System	K2M, Inc	MNI	Class II	2012-04-04
K113433	Simplexa C. Difficile Universal Direct	DiaSorin Molecular LLC	OMN	Class I	2012-04-04