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 843 of 3530

510(k) clearances, page 843 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123996	Radial-Cuf Non-Invasive Blood Pressure Cuff	GE Medical Systems Information Technologies, Inc.	DXQ	Class II	2013-04-09
K123978	Capstone L Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2013-04-09
K123916	Psa Series	Osypka Medical GmbH	DTE	Class II	2013-04-09
K123786	Stryker Universal Orbital Floor System	Stryker Corp.	JEY	Class II	2013-04-09
K123770	Warming Jelly Personal Lubricant	Wisconsin Pharmacal Co., LLC	NUC	Class II	2013-04-09
K123153	Attain Command+surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,attain Select	Medtronic Ireland	DQY	Class II	2013-04-09
K122112	2004-Oc Massage System, 2008-Oc Massage System	Bio Compression Systems, Inc.	IRP	Class II	2013-04-09
K112996	Euroimmun Anti-Ena Pool Elisa (Igg)	Euroimmun US Inc.	LLL	Class II	2013-04-09
K123962	Otomag Bone Conduction Hearing System	Sophono, Inc.	LXB	Class II	2013-04-08
K123664	Incoris Zi	Sirona Dental Systems GmbH	EIH	Class II	2013-04-08
K122966	Xp200	BTL Industries, Inc	GEI	Class II	2013-04-08
K130782	Accumesh Deployment System	Medtronic, Inc.	ORQ	Class II	2013-04-05
K130744	Ligasure 5Mm Blunt Tip Laparoscopic Sealer/divider	Medtronic, Inc.	GEI	Class II	2013-04-05
K130698	Dimension Vista Progesterone Calibrator (Prog Cal)	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2013-04-05
K130588	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2013-04-05
K130521	Isolator Linear Pen	AtriCure, Inc.	OCL	Class II	2013-04-05
K130469	Liaison Tsh, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3	Diasorin Inc.	JLW	Class II	2013-04-05
K130400	Meretec Cs, Cortical Screws	Merete GmbH	HWC	Class II	2013-04-05
K130340	Locking Bone Plates and Screws	Weigao Orthopaedic Device Co., Ltd.	HRS	Class II	2013-04-05
K130308	Noblus Ultrasound Diagnostic System	Hitachi Aloka Medical, Ltd.	IYN	Class II	2013-04-05
K130237	Pontic Paint	Reliance Orthodontic Products, Inc.	NXC	Class II	2013-04-05
K130069	Innova Epvision 2.0, Innova Epvision 2.0	GE Healthcare	LLZ	Class II	2013-04-05
K130044	Sidekick Ez Frame External Fixation System	Wrightmedicaltechnologyinc	KTT	Class II	2013-04-05
K130006	Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts	Cook Biotech Incorporated	PAI	Class III	2013-04-05
K124027	Monster Screw System	Apogee Orthosolutions	HWC	Class II	2013-04-05
K123961	Sentrex Biosponge Mpd	Bionova Medical, Inc.	KGN	Unclassified	2013-04-05
K123892	Mepilex Transfer Ag	Molnlycke Health Care	FRO	Unclassified	2013-04-05
K123806	Fibroscan	Echosens	IYO	Class II	2013-04-05
K123796	Neuro Omega System	Alpha Omega Engineering Ltd.	GZL	Class II	2013-04-05
K123701	Hearlab Aca	Frye Electronics, Inc.	GWJ	Class II	2013-04-05
K123429	Olympus Energy Power System (Eps)	Gyrus ACMI, Inc.	GEI	Class II	2013-04-05
K123410	Healthy Sleep Appliance	Healthy Sleep Dental Laboratory	LRK	Class II	2013-04-05
K123353	Ciq Controller, Ciq Wands	ArthroCare Corporation	GEI	Class II	2013-04-05
K123243	Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2013-04-05
K123241	Arthrex Fracture Plates	Arthrex GmbH	HRS	Class II	2013-04-05
K123122	Glenoid Intelligent Reusable Instrument System (Glenoid Iris)	Cleveland Clinic	KWS	Class II	2013-04-05
K123089	Freestyle Auto-Assist Software Verson 2.0 with Model Prt24238-001	Abbott Medical	NBW	Class II	2013-04-05
K122453	Midas Touch, Nitrile Examination Gloves, Powder-Free, Grey	Industrial Clothings, Ltd.	LZA	Class I	2013-04-05
K122307	Diavue Prudential Blood Glucose Monitoring System	Biocare Corp.	NBW	Class II	2013-04-05
K122198	6.00Mm X 6.00Mm Macro External Implant System	Oco Biomedical	DZE	Class II	2013-04-05
K122049	Neuropro Low Profile Cranial Plating System	Kinamed Inc	GWO	Class II	2013-04-05
K121478	Nuk Expressivetm Double Electric Breast Pump	Mapa GmbH	HGX	Class II	2013-04-05
K121281	Simpli Simpler Implant System	Simpler Implant Solutions	DZE	Class II	2013-04-05
K130765	Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol II	ELITechGroup Inc	JIX	Class II	2013-04-04
K130422	Phantom Fiber Biofiber Suture	TORNIER Inc.	NWJ	Class II	2013-04-04
K123808	Agility	Elekta Limited	IYE	Class II	2013-04-04
K123732	Hysteroscopy Pump Hm6	Novanta Medical GmbH	HIG	Class II	2013-04-04
K123507	Kci Npwt Gauze Dressing	KCI USA, Inc.	OMP	Class II	2013-04-04
K123263	Hdrplus, Add in Prostate Module for Hdrplus	Eckert & Ziegler Bebig GmbH	MUJ	Class II	2013-04-04
K122688	Nova Max Mini Blood Glucose and B-Ketone Monitor	Nova Biomedical Corporation	LFR	Class II	2013-04-04