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 823 of 3530

510(k) clearances, page 823 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130682	Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit, Basic-Kit	Hager & Meisinger GmbH	DZL	Class II	2013-08-13
K130672	Optiflow II Flowable Composite, Lc	Pac-Dent International, Inc.	EBF	Class II	2013-08-13
K130398	Sofia(r) Rsv Fia	Ortho-Clinical Diagnostics, Inc.	GQG	Class I	2013-08-13
K123834	Easystand Bantam Medium	Altimate Medical, Inc.	INO	Class II	2013-08-13
K123814	Humelock II Cemented Shoulder System	Fx Shoulder Solutions SAS	KWT	Class II	2013-08-13
K123473	Hoper Ptca Balloon Catheter	Lepu Medical Technology (Beijing) Co., Ltd	LOX	Class II	2013-08-13
K123443	Precise Shp Diode Laser	Cao Group, Inc.	GEX	Class II	2013-08-13
K123061	Ace Monopolar Attachment	Bioeconeer, Inc.	GEI	Class II	2013-08-13
K132197	Convey 7F Guiding Catheter, Convey 8F Guiding Catheter	Pendracare International B.V.	DQY	Class II	2013-08-12
K131536	Immulite 2000 Psa Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-08-12
K131532	Electromagnetic Transmitting Stylet	Halyard Health	KNT	Class II	2013-08-12
K131133	Vivorte Bvf Lite	Vivorte, Inc.	MQV	Class II	2013-08-12
K131032	Philips Suresigns Central	Philips North America LLC	MHX	Class II	2013-08-12
K131014	Pana Spray Plus	NSK America Corp.	EFB	Class I	2013-08-12
K123891	Spartan Rx Cyp2c19 Test System	Spartan Bioscience, Inc.	NTI	Class II	2013-08-12
K123864	Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam Sb 3 Capsule Endoscopy System	Given Imaging Ltd.	NEZ	Class II	2013-08-12
K123699	Fahl Tracheostomy Tubes (Multiple)	Andreas Fahl Medizintechnik-Vertrieb GmbH	JOH	Class II	2013-08-12
K132226	Metafix Blp Plate, Size 31, Left, Metafix Blp Plate, Size 31,Right	Merete GmbH	HRS	Class II	2013-08-09
K132165	Qlab Quantification Software	Philips North America LLC	LLZ	Class II	2013-08-09
K132154	Capsure Ps System	Spine Wave Inc	MNI	Class II	2013-08-09
K132129	Prodesse Proflu+ Assay	Gen-Probe Prodesse, Inc.	OCC	Class II	2013-08-09
K131522	Core Pedicle Screw System	Core-Nexus	MNI	Class II	2013-08-09
K131441	Liaison Toxo Igm II, Liaison Control Toxo Igm II	Diasorin Inc.	LGD	Class II	2013-08-09
K131419	Acura Plus Multi Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2013-08-09
K131415	Live View Panel (Lvp)	Neurotronics, LLC	OLV	Class II	2013-08-09
K131279	Iconacy I-Hip System	Iconacy Orthopedic Implants, LLC	LPH	Class II	2013-08-09
K131205	Arthrocare Head and Neck Coblation Wand	ArthroCare Corporation	GEI	Class II	2013-08-09
K131029	Accu-Chek Aviva Plus Test Strip	Roche Diagnostics GmbH	NBW	Class II	2013-08-09
K130863	Facet Screw System	Spinal USA	MRW	Unclassified	2013-08-09
K130821	Intel-Ge Care Innovations Connect Rcm	Intel-Ge Care Innovations, LLC	DRG	Class II	2013-08-09
K130685	Hitachi Clinical Analyzer S Test Reagent Cartridges for Ld and Amy	Canon Medical Diagnostics USA, Inc.	JFJ	Class II	2013-08-09
K130484	Maxforce Biliary Dilatation Catheter and Hurricane Rx Biliary Catheter	Boston Scientific Corporation	FGE	Class II	2013-08-09
K130089	Crosstrees Pva Pod	Crosstrees Medical, Inc.	NDN	Class II	2013-08-09
K124014	Surefix Interspinous Fusion System	Jg Spine, LLC	PEK	Class II	2013-08-09
K123553	Zimmer A.t.s. 4000Ts Automatic Tourniquet System	Zimmer GmbH	KCY	Class I	2013-08-09
K123076	Profthand Mechanical Wheelchair	Harmony Hill International	IOR	Class I	2013-08-09
K122562	E-Teng Model Eor 1	E-Teng Technology Inc.	IPL	Class II	2013-08-09
K132090	Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2	Randox Laboratories, Limited	DLJ	Class II	2013-08-08
K131945	Ge Datex-Ohmeda Avance Cs2	GE Healthcare	BSZ	Class II	2013-08-08
K131869	Pts-X Sizing Balloon Catheter	Numed Inc	MJN	Class II	2013-08-08
K131810	Osseus Black Diamond Pedicle Screw System	Osseus Fusion Systems LLC	MNH	Class II	2013-08-08
K131759	Metallic Locking Compression Bone Plates and Screws System	Tianjin Walkman Biomaterial Co., Ltd.	HRS	Class II	2013-08-08
K131744	Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software	Terumobct, Inc.	LKN	Unclassified	2013-08-08
K131694	Nmi Port II Catheter	Boston Scientific Corporation	LJT	Class II	2013-08-08
K131674	Prebent Plating with Virtual Surgical Planning	Biomet Microfixation	JEY	Class II	2013-08-08
K131538	Caplox II Pedicle Screw System/towerlox Pedicle Screw System	CAPTIVA SPINE, Inc.	MNH	Class II	2013-08-08
K130846	Midas Touch, Nitrile Examination Gloves, Powder Free, Green	Industrial Clothings, Ltd.	LZA	Class I	2013-08-08
K130820	Expandable Lumbar Interbody System	Nu Vasive, Incorporated	MAX	Class II	2013-08-08
K130273	Panpac Vaginal Dilators	Panpac Medical Corporation	HDX	Class II	2013-08-08
K130179	Mp Vial Adapter 13Mm	West Pharma. Services IL, Ltd.	LHI	Class II	2013-08-08