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 844 of 3530

510(k) clearances, page 844 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122194	Life-Care Vaginal Probe Life-Care Anal Probe	Everyway Medical Instruments Co., Ltd.	KPI	Class II	2013-04-04
K121951	Liaison Ft4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3	Diasorin Inc.	CEC	Class II	2013-04-04
K121576	Immulite 2000 Anti-Ccp Igg Assay	Siemens Healthcare Diagnostics Inc.	NHX	Class II	2013-04-04
K130659	Speqrt Ultrasound System	Signostics Limited	IYN	Class II	2013-04-03
K130423	The Richard Wolf Endocam Logic Hd Camera System 5525	Richard Wolf Medical Instruments Corp.	FET	Class II	2013-04-03
K130285	Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens	The Lagado Corp.	LRX	Class II	2013-04-03
K130194	Acculif Xl Cage	Coalign Innovations, Inc.	MAX	Class II	2013-04-03
K130023	K100 Neutral Displacement Needle Free Connector	NP Medical	FPA	Class II	2013-04-03
K123942	Stryker Ivas Balloon Catheter	Stryker Corp.	NDN	Class II	2013-04-03
K123829	Portable Therapeutix Squid Active Cold Compression Device and Cold Pack	Portable Therapeutix	IRP	Class II	2013-04-03
K130576	Celsite Implantable Access Port Systems	B. BRAUN INTERVENTIONAL SYSTEMS Inc.	LJT	Class II	2013-04-02
K130470	Bd Max Cdiff Assay, Bd Max Instrument	Geneohm Sciences Canada, Inc. (BD Diagnostics)	OZN	Class II	2013-04-02
K130453	Excelsior	Eyekor, LLC	NFJ	Class II	2013-04-02
K130361	Thermofinder; Thermocare	Hubdic Co., Ltd.	FLL	Class II	2013-04-02
K124042	Tanda Mini Skincare System	Syneron Beauty	OLP	Class II	2013-04-02
K123943	Amecath Dual Lumen Hemodialysis Catheter	Ameco Medical Industries	MSD	Class II	2013-04-02
K123860	Inmode Sr Ipl Device	Inmode MD, Ltd.	ONF	Class II	2013-04-02
K123820	Bossong Hosiery Medical Compression Stockings 8-15 Mmhg, Bossong Hosiery Anti-Embolism Stockings 10-20 Mmhg, Bossong Hos	Bossong Hosiery Mills	DWL	Class II	2013-04-02
K123541	Syngo.ct Neuro Perfusion	Siemens Medical Solutions USA, Inc.	JAK	Class II	2013-04-02
K121916	Intuition	Terarecon, Inc.	LLZ	Class II	2013-04-02
K130402	Spider System Kolibri Cement Needle	Sintea Plustek, LLC	NDN	Class II	2013-04-01
K130286	Streamline Mis Spinal Fixation System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2013-04-01
K123997	Trans1lateral Interbody Fusion System	TranS1	MAX	Class II	2013-04-01
K123972	Walkaide System	Innovative Neurotronics, Inc.	GZI	Class II	2013-04-01
K123954	Infinity Total Ankle System	Wrightmedicaltechnologyinc	HSN	Class II	2013-04-01
K123906	Vertex Reconstruction System, Vertext Select Reconstruction System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2013-04-01
K123850	Ifuse Implant System	SI-Bone, Inc.	OUR	Class II	2013-04-01
K123733	Cardioblate Cryoflex Surgical Ablation System	Medtronic, Inc.	OCL	Class II	2013-04-01
K123445	Nmi Coaxial Microintroducer Set	Boston Scientific Corporation	DRE	Class II	2013-04-01
K120561	Neuroblate System	Monteris Medical Corp	GEX	Class II	2013-04-01
K120056	Human Kappa and Lambda Free Kitfor Use on the Spa Plus Analyser	The Binding Site Group Ltd.	DFH	Class II	2013-04-01
K130653	Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered Articulating Endoscopic Linear Cu	Ethicon Endo-Surgery Inc	GDW	Class II	2013-03-29
K130537	Biopsy Sciences Llc Hydromark Breast Biopsy Site Marker	Biopsy Sciences, LLC	NEU	Class II	2013-03-29
K130497	D4000 Drive System; D4000a Drive System with Irrigation	Linvatec Corporation D/B/A Conmed Linvatec	HBC	Class II	2013-03-29
K130223	Rmgi Fill	Pulpdent Corporation	EMA	Class II	2013-03-29
K124008	Ips E. Max Press Abutment Solutions for Nobel Biocare	Ivoclar Vivadent, Agin	NHA	Class II	2013-03-29
K123789	Swift Fx Nano	ResMed Corp	BZD	Class II	2013-03-29
K123642	Muscle Stimulation System	Niveus Medical, Inc.	IPF	Class II	2013-03-29
K123562	Flower Small and Medium Bone Implants	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HRS	Class II	2013-03-29
K123509	Scenaria Phase 2 Whole-Body X-Ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2013-03-29
K123484	Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon A)soft (Hydrophilic) Contact Lens	St. Shine Optical Co., Ltd.	LPL	Class II	2013-03-29
K123407	Cellulaze Laser	Cynosure, LLC	OYW	Class II	2013-03-29
K123014	Litecure Therapy System Model Lts-1500	LiteCure, LLC	PDZ	Class II	2013-03-29
K122501	Aei Dr. Terauchi Ultrasonic Tips	American Eagle Instruments	ELC	Class II	2013-03-29
K122221	Nexus Ir30 Non-Contact Infrared Forehead Thermometer	Taidoc Technology Corporation	FLL	Class II	2013-03-29
K130625	12Mm and 13Mm Tibial Nails	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2013-03-28
K130483	Boehringer Gastric Sizing Tube	Boehringer Laboratories, LLC	KNT	Class II	2013-03-28
K130336	5Mp Monochrome Lcd Monitor, Radiforce Gx540	Eizo Nanao Corporation	LLZ	Class II	2013-03-28
K130176	Firebird Spinal Fixation System	Orthofix SRL	NKB	Class II	2013-03-28
K123984	Quantien Measurement System	Radi Medical Systems AB	DQK	Class II	2013-03-28