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 913 of 3530

510(k) clearances, page 913 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120258	Duet Trs Reloads, Duet Trs Reloads with Tri-Staple Technology, Endo Gia Universal and Ultra Universal Staplers	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2012-02-29
K120078	Healix Advance Br Anchor	Depuy Mitek Inc., Johnson and Johnson Company	MAI	Class II	2012-02-29
K113828	Dynanail Ankle Arthrodesis Nail	Medshape, Inc.	HSB	Class II	2012-02-29
K113550	Vanguard Complete Knee System	Biomet Manufacturing Corp	JWH	Class II	2012-02-29
K113364	2.7Mm Lcp Ulna Osteotomy System	Synthes (USA) Products LLC	HRS	Class II	2012-02-29
K113272	Inomax Ds(delivery Systems	Mallinckrodt Manufacturing LLC	MRN	Class II	2012-02-29
K113207	Sono Tap, Tuohy Sono	Pajunk GmbH Medizintechnologie	BSP	Class II	2012-02-29
K112891	Apex Revision Knee Systems	Omni Life Science, Inc.	JWH	Class II	2012-02-29
K112815	Quantum Bariatric 451	Pride Mobility Product Corporration	ITI	Class II	2012-02-29
K111341	Cleane / Cleane Pop	Medicon Co., Ltd.	OZC	Class II	2012-02-29
K120290	Toshiba 1.5T Cardiac Coil	Quality Electrodynamics	MOS	Class II	2012-02-28
K120067	Mosaiq Oncology Information System	Elekta Limited	IYE	Class II	2012-02-28
K120024	Mectalif Transforaminal	Medacta International SA	MAX	Class II	2012-02-28
K113346	Neon System	Ulrich GmbH & Co. KG	KWP	Class II	2012-02-28
K113202	Tissue Marker	Focal Therapeutics	NEU	Class II	2012-02-28
K113148	E-Pass	Synexmed(Shenzhen)Company Limited	DTL	Class II	2012-02-28
K111893	Vitek(r) 2 Streptococcus Tetracycline	bioMerieux, Inc.	LON	Class II	2012-02-28
K111456	Medisign Blood Glucose Monitoring System	Tianjin Empecs Medical Device Co., Ltd.	NBW	Class II	2012-02-28
K113844	Radiforce Rx240	Eizo Nanao Corporation	LLZ	Class II	2012-02-27
K113545	Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han	DePuy Mitek, Inc.	GEI	Class II	2012-02-27
K113482	Journey II Deep Dished Articular Inserts	Smith & Nephew, Inc.	JWH	Class II	2012-02-27
K113276	Catalyst	C-Rad Positioning AB	IYE	Class II	2012-02-27
K113275	Compressible Limb Therapy System	Wonjin Mulsan Co., Ltd.	IRP	Class II	2012-02-27
K113231	Warp10,warp75	Quantum Devices, Inc.	ILY	Class II	2012-02-27
K113007	Bionime Diabetes Management System Vi.0	Bionime Corporation	JQP	Class I	2012-02-27
K112807	X-Ray Vva	Medis Medical Imaging Systems, B.V.	LLZ	Class II	2012-02-27
K110821	Barf Band	Doodlebug Products, LLC	MVV	Unclassified	2012-02-27
K103824	Human Iga Liquid Reagent Kit for Use on Spa Plus	The Binding Site	CFN	Class II	2012-02-27
K120381	Q50 Plus Stent Graft Balloon Catheter	Qxmedical, LLC	DQY	Class II	2012-02-24
K120343	Connex Workstation	Welch Allyn Inc	MWI	Class II	2012-02-24
K120314	Welldoc Diabetes Manager System and Diabetes Manager Rx System	Welldoc	MRZ	Class II	2012-02-24
K120301	Mediguide Technology	St. Jude Medical, Mediguide Navigation Systems	DQK	Class II	2012-02-24
K120242	Jetstream Navitus L System	Pathway Medical Technologies, Inc.	MCW	Class II	2012-02-24
K120241	Linear Hip Stem, Size 5	Encore Medical, LP	LPH	Class II	2012-02-24
K120229	Envoy Distal Access Guiding Catheter	Cerenovus, Inc.	DQY	Class II	2012-02-24
K113596	Masimo Set Reusable Oximetry Sensors	Masimo Corporation	DQA	Class II	2012-02-24
K113587	Automatically Retractable Safety Syringe (with Fixed Needle)	Shantou Wealy Medical Instrument Co., Ltd.	MEG	Class II	2012-02-24
K113454	14 Wire Standard, 14 Wire Ls	Medtronic, Inc.	DQX	Class II	2012-02-24
K113408	Q. Freeze (Motion Vue2)	GE Healthcare	KPS	Class II	2012-02-24
K113254	Smr Modular Glenoid-Metal-Back Smr Modular Glenoid-Liner Smr Modular Glenoid-Bone Screws	Lima Corporate S.p.A.	PHX	Class II	2012-02-24
K113203	Sony Lmd-2451Mt Lcd Monitor	Sony Electronics Inc.	GCJ	Class II	2012-02-24
K113190	Tru Legionella	Meridian Bioscience Inc	MJH	Class II	2012-02-24
K112861	Sintea Plustek Anterior Cervical Plate System	Sintea Plustek, LLC	KWQ	Class II	2012-02-24
K112791	Sitescrub Ipa Device	Bard Access Systems, Inc.	LKB	Unclassified	2012-02-24
K112777	Sol-M Exchangeable Needles	Sol-Milennium Medical, Inc.	FMI	Class II	2012-02-24
K112691	Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2012-02-24
K112690	Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2012-02-24
K120027	Pilairo Nasal Pillows Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2012-02-23
K120019	Collagen Ribbon	Wrightmedicaltechnologyinc	FTM	Class II	2012-02-23
K113805	Fixate Tissue Band	Anulex Technologies, Inc.	GZB	Class II	2012-02-23