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 790 of 3530

510(k) clearances, page 790 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133510	Neodent Implant System	Jj Industria E Comercio de Materiais Dentarios SA	DZE	Class II	2014-02-24
K133447	Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres	Celonova Biosciences, Inc.	NAJ	Class II	2014-02-24
K133404	Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control Lmh	Phadia AB	DGC	Class II	2014-02-24
K132480	Air-Flow Handy 3.0 Perio	E.M.S. - Electro Medical Systems SA	EFB	Class I	2014-02-24
K131909	Dalton Lift Chair	Dalton Instrument Corp.	INO	Class II	2014-02-24
K131252	Puritan Bennett 980 Series Ventilator System	Medtronic, Inc.	CBK	Class II	2014-02-24
K123697	Matricel Dental Barrier Membrane	Matricel GmbH	NPL	Class II	2014-02-24
K133948	Bard(r) Monopty(r) Disposable Core Biopsy Instrument, Bard(r) Max-Core(r) Disposable Core Instrument	Bard Peripheral Vascular Inc	KNW	Class II	2014-02-21
K133710	Lzi Multiple Analyte Set A;b;c Drugs of Abuse Controls	Lin-Zhi International Inc	DKB	Class II	2014-02-21
K133576	Monitor B40	GE Medical Systems China Co., Ltd.	MHX	Class II	2014-02-21
K133509	Easy Plus II Blood Glucose Monitoring System,easy Plus II Multi Blood Glucose Monitoring System,smartest Persona II Bloo	Biotest Medical Corp.	NBW	Class II	2014-02-21
K133491	Advia Centaur Testosterone (Tsto)	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	2014-02-21
K133432	Sherpa Pak Cardiac Transport System	Paragonix Technologies Inc.	MSB	Class II	2014-02-21
K133409	Digital Flat Panel X-Ray Detector/ 910Sga	Rayence Co., Ltd.	MQB	Class II	2014-02-21
K133234	T-Type D-Kat, R-Type D-Kat	Keeler Ltd.	HKY	Class II	2014-02-21
K132935	Artiste Solution with Sys_vc10c and Syngo Rt Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme	Siemens Medical Solutions USA, Inc.	IYE	Class II	2014-02-21
K132874	Lumencare Azure Set F6, 150Cm, Lumecare Azure Set 5F, 150 Cm, Lumencare Azure Set 5F, 140 Cm	Nucletron BV	JAQ	Class II	2014-02-21
K132842	Flaatz 600 Series (Flaatz 600/601)	DRTECH Corporation	MQB	Class II	2014-02-21
K132457	Fora Diamond Nexus Mini Infrared Forehead Thermometer	Biocare Asia Corporation, Ltd.	FLL	Class II	2014-02-21
K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc	DQA	Class II	2014-02-21
K132229	Omni Patent Monitors	Infinium Medical, Inc	MWI	Class II	2014-02-21
K132219	Straumann(r) Variobase(tm) Abutment Nnc, Straumann(r) Variobase(tm) Abutment Rn, Straumann(r) Variobase(tm) Abutment Wn,	Straumann USA, LLC	NHA	Class II	2014-02-21
K132158	Novohip Total Hip System	Novosource, LLC	LPH	Class II	2014-02-21
K132039	Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N Slim	JEDMED Instrument Company	EQN	Class II	2014-02-21
K131990	Oxygen Generator Liquefier - (Ogl)	Essex Cryogenics of Missouri, Inc.	CAW	Class II	2014-02-21
K131783	Polaroid Contactspod	Viopti, Ltd.	LRX	Class II	2014-02-21
K131481	Freedom Pck Components	Maxx Orthopedics Inc.	JWH	Class II	2014-02-21
K131426	Medline Biopsy Valve	MEDLINE INDUSTRIES, LP - Northfield	OCX	Class II	2014-02-21
K131066	Axiom Reg	Anthogyr SAS	DZE	Class II	2014-02-21
K140160	Relieva Scout Sinus Dilation System	Acclarent Inc	LRC	Class I	2014-02-20
K133617	Jazz System	Implanet	OWI	Class II	2014-02-20
K133585	Inbone Total Ankle	Wrightmedicaltechnologyinc	HSN	Class II	2014-02-20
K133567	Unify(r) Dynamic Anterior Cervical Plate System	Globus Medical, Inc.	KWQ	Class II	2014-02-20
K133076	Novagold High Performance Guidewire	Neometrics, Inc.	OCY	Class II	2014-02-20
K132949	Pellefirm	Ellman International, Inc.	PBX	Class II	2014-02-20
K132321	Jms Syringe	JMS North America Corp.	FMF	Class II	2014-02-20
K131772	Cantata(r) 2.9 Microcatheter	Cook Inc.	KRA	Class II	2014-02-20
K131196	Infant Phototherapy Bilitron Sky 5006	Fanem Lda	LBI	Class II	2014-02-20
K131145	Proinsert	Nidacon International AB	MQK	Class II	2014-02-20
K131041	Advanced Perfusion System 1	Terumo Cardiovascular Systems Corporation	DTQ	Class II	2014-02-20
K140214	30.0 Inch Color Lcd Monitor Ccl650i2 (Cl30650, Md302c6)	JVCKENWOOD Corporation	LLZ	Class II	2014-02-19
K140181	Medos Hilite Infant Oxygenator	Medos Medizintechnik AG	DTZ	Class II	2014-02-19
K140170	Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge	Cardica, Inc.	GDW	Class II	2014-02-19
K140030	Dc-N3/dc-N3s Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2014-02-19
K133845	8Mm Trocar Kit	Intuitive Surgical, Inc.	GCJ	Class II	2014-02-19
K133564	Modification to Nautilus Spinal System	Life Spine	NKB	Class II	2014-02-19
K132958	Medicinal Leeches	Biopharm UK Ltd	NRN	Unclassified	2014-02-19
K132323	Rs-3000 Advance	Nidek Co., Ltd.	OBO	Class II	2014-02-19
K140177	Medos Hilite Oxygenator	Medos Medizintechnik AG	DTZ	Class II	2014-02-18
K133449	Kasm Knee Articulating Spacer Molds	Ortho Development Corp.	JWH	Class II	2014-02-18