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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1466 of 3531

510(k) clearances, page 1466 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023286	Carecompanion Patient Station/carecompanion Patient Station	Neptec Design Group, Ltd.	DXN	Class II	2003-05-02
K021952	Hivox Dreamate Dm-800	Hivox Biotek Inc.	GZJ	Class II	2003-05-02
K031202	Medipalm-20	Braebon Medical Corp.	OLV	Class II	2003-05-01
K031162	Smith & Nephew Orthopaedic Cabling System	Smith & Nephew, Inc.	JDQ	Class II	2003-05-01
K030933	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	2003-05-01
K030759	Little Coach	Wheelchair & Scooter Express	INI	Class II	2003-05-01
K030741	Autostat II Anti-Cardiolipin Iga Elisa	Hycor Biomedical	MID	Class II	2003-05-01
K030733	Mayo Conservative Hip Prosthesis, Model 8026 Series	Zimmer GmbH	LPH	Class II	2003-05-01
K030433	Stratusoct with Rnfl Normative Database	Carl Zeiss Meditec Inc	HLI	Class II	2003-05-01
K030432	Imc-Heartway Model Hps Electric Powered Wheelchair	Imc-Heart Way LLC	ITI	Class II	2003-05-01
K030017	Chump	Colours 'N Motion	IOR	Class I	2003-05-01
K024175	Sunpex Technologies Model Pw	Sunpex Technology Co., Ltd.	ITI	Class II	2003-05-01
K023602	Small Volume Nebulizer	Medtronic, Inc.	CAF	Class II	2003-05-01
K031213	Aquasens Fluid Monitoring System	Davol, Inc.	HIG	Class II	2003-04-30
K031185	Abbott Plum a+ Infusion Pump with a Hpl/rs Plug-and-Play Module	Abbott Medical	FRN	Class II	2003-04-30
K030690	Codonics Ep-1000 Medical Color Dry Imagers	Codonics, Inc.	LMC	Class II	2003-04-30
K030451	Carbon Medical Technologies Injection Needle	Carbon Medical Technologies, Inc.	FBK	Class II	2003-04-30
K030415	Angiodynamics, Inc. Morpheus Picc and Procedure Kit	Boston Scientific Corporation	LJS	Class II	2003-04-30
K023905	Athena Pelvic Muscle Trainer	Athena Feminine Technologies, Inc.	KPI	Class II	2003-04-30
K023869	'Rapidtec'-5M-Multiple Dip Test	American Bio Medica Corp.	DJR	Class II	2003-04-30
K023847	Hemo-Stream Hemodialysis Catheter Set	Rex Medical LP	MSD	Class II	2003-04-30
DEN030001	Niox Article No: 02-1000	Aerocrine AB	MXA	Class II	2003-04-30
K031002	Synchron Systems Opiate Reagent	Siemens Healthcare Diagnostics Inc.	DJG	Class II	2003-04-29
K030365	Deroyal Drapes, Sterile, Non-Sterile	DeRoyal Industries, Inc.	KKX	Class II	2003-04-29
K030303	Freezor Xtra Surgical Cardiac Cryoablation Device and Cct.2 Cardiac Cardiac Cryoablation Cryoconsole	Medtronic CryoCath LP	GEH	Class II	2003-04-29
K030133	Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece	Dentalez Group	EBF	Class II	2003-04-29
K023672	X O Odontosurge 4	Xo Care A/S	EKZ	Class II	2003-04-29
K021174	Ecom Endotrachial Cardiac Output Monitor	Imagyn Surgical	DSB	Class II	2003-04-29
K020925	Carbodissecting Endoscope	Endo Surgical Devices, Inc.	DWX	Class II	2003-04-29
K020421	Go Medical Patient Controlled Analgesia Devices	Hennig Enterprises Europe S.r.l.	MEA	Class II	2003-04-29
K020418	Go Medical Patient Controlled Analgesia Devices	P.T. Greenleaf	MEA	Class II	2003-04-29
K031127	Orthopedic Wire	Howmedica Osteonics Corp	JDR	Class II	2003-04-28
K031028	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate Inc	JEY	Class II	2003-04-28
K031009	Modification to Bio-Logic Evoked Potential (Ep) System	Bio-Logic Systems Corp.	GWJ	Class II	2003-04-28
K030942	Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control	Medical Analysis Systems, Inc.	JJY	Class I	2003-04-28
K030585	Sculpting Resin	Bisco Inc	EBD	Class II	2003-04-28
K030428	Roche Online Tdm Phenytoin	Roche Diagnostics GmbH	DIP	Class II	2003-04-28
K030405	Qms / Multigent Valproic Acid Reagent, Part #396075	Seradyn, Inc.	LEG	Class II	2003-04-28
K030364	Deroyal Gowns, Sterile, Non-Sterile	DeRoyal Industries, Inc.	FYA	Class II	2003-04-28
K030297	Flexible Rubber Electrodes, Models: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130	Enraf-Nonius B.V.	GXY	Class II	2003-04-28
K030234	Cozart Eia Cocaine Oral Fliud Kit	Cozart Bioscience, Ltd.	DIO	Class II	2003-04-28
K023991	Chromocheck Antithrombin 25; Chromocheck Antithrombin 50	Precision BioLogic Inc.	JBQ	Class II	2003-04-28
K023860	Microalbumin Reagent Set and Calibrators	Horiba Instruments Incorporated	DDZ	Class II	2003-04-28
K030983	Truflow Dual-Lumen Polyurethane Long-Term Straight Dialysis Catheter (12.5 Fr X 24 Cm) with Tray, Truflow Dual-Lumen Poy	Abbott Medical	MSD	Class II	2003-04-25
K030975	Exeltra Plus High Flux Dialyzer, Model 210	Baxter Healthcare Corporation	KDI	Class II	2003-04-25
K030974	Exeltra High Flux Dialyzer, Models 150 & 170	Baxter Healthcare Corporation	KDI	Class II	2003-04-25
K030959	Bare Laser Fiber Models Dblf-40, Dblf-60, Dblf-60-1, Dclf-600B, Dslf-60, Dblf-100	Laser Peripherals LLC	GEX	Class II	2003-04-25
K030353	Monocanalicular Stents, Lacrimal Intubation Sets	Grace Medical, Inc.	OKS	Unclassified	2003-04-25
K030276	Flat Panel Displays, Cdl Series	Totoku Electric Co., Ltd.	LLZ	Class II	2003-04-25
K030274	Medical Flat Panel Display, Me315l	Totoku Electric Co., Ltd.	LLZ	Class II	2003-04-25