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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2937 of 3529

510(k) clearances, page 2937 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850495	Akufon Therapeutic Massager	Jansson A/S	IRO	Class I	1986-01-03
K854510	Minxray 500M Mammographic System	Minxray Inc	IZH	Class II	1986-01-01
K854368	Cell-Dyn 1500 Multi-Parameter Hematology Analyzer	Abbott Diagnostics	GKZ	Class II	1986-01-01
K854242	Qbc Centrifugal Hematology System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1986-01-01
K854219	Kodak M35 X-Omat Processor	Eastman Kodak Company	IXW	Class II	1986-01-01
K853482	Ace Computer System	Cardiac Medical Systems Corp.	IYX	Class I	1986-01-01
K853069	Tandem Icon Rubella Igg Immunoenzymetric Assay Kit	Hybritech, Inc.	LFX	Class II	1986-01-01
K853031	Ject-Aid	Autoject Systems, Inc.	KZE	Class II	1986-01-01
K852866	Hydro-Bac Filter	Medicomp, Inc.	CAI	Class I	1986-01-01
K854363	Saratoga Sct Heated Humidification System	Saratoga Medical Instrumentation, Inc.	BTT	Class II	1985-12-31
K854052	Csm Medium	Northern Scientific, Inc.	LYX	Unclassified	1985-12-31
K854043	Automatic Impedance Audiometer, Ta-7B	Teledyne Avionics Div. of Teledyne	ETY	Class II	1985-12-31
K854001	Certi-Form	Beltone Electronics Corp.	ESD	Class I	1985-12-31
K851972	Diasonics Ada400 Advanced Digital Array	Diasonics, Inc.	IYO	Class II	1985-12-31
K854764	Lectrostill Distilled Water U.s.p.	Electrified Companies, Inc.			1985-12-30
K854708	Dart Ck-Mb Reagent System	Coulter Electronics, Inc.	JHS	Class II	1985-12-30
K854611	Ramp Urine Hcg Assay	Monoclonal Antibodies, Inc.	JHI	Class II	1985-12-30
K854422	Series 25 Slimline Cryo Probes	Keeler Instruments, Inc.	HQA	Class II	1985-12-30
K854411	Keeler-Compact Cryo System	Keeler Instruments, Inc.	HQA	Class II	1985-12-30
K854402	The New Mcintyre I.a. Handpiece	MicroSurgical Technology Inc	HMX	Class I	1985-12-30
K854401	The New Mobile Tip Mcintyre Cannula	MicroSurgical Technology Inc	HMX	Class I	1985-12-30
K853990	Osm3 Hemoximeter	Radiometer America, Inc	JKS	Class I	1985-12-30
K853217	Qad-1 Angio Dynograph Ultraso W/5.0 7.5 Mhz Probes	Quantum Medical Systems, Inc.	IYO	Class II	1985-12-30
K852653	Healthteam Digital Blood Pressure Kit 8115	Healthteam	DXN	Class II	1985-12-30
K852459	Healthteam Digital Blood Pressure Kit 8175	Healthteam	DXN	Class II	1985-12-30
K852458	Healthteam Digital Blood Pressure Kit 8145	Healthteam	DXN	Class II	1985-12-30
K852457	Healthteam Digital Blood Pressure Kit 8165	Healthteam	DXN	Class II	1985-12-30
K843717	Viratek Small Particle Aerosol Generat	Viratek, Inc.			1985-12-30
K842066	Peri-Guard Pericardial Patch	Genetic Laboratories, Inc.	DXZ	Class II	1985-12-30
K840571	EKG 503A	Bosch Hearing Instruments, Inc.	DPS	Class II	1985-12-30
K840569	EKG 501 a	Bosch Hearing Instruments, Inc.	DPS	Class II	1985-12-30
K854827	Link Cortical Screws	Link America, Inc.	HWC	Class II	1985-12-27
K854826	Link Cancellous Screws	Link America, Inc.	HWC	Class II	1985-12-27
K854739	American Sterile Surgical Absorbent Towel	American Hospital Supply			1985-12-27
K854657	Intracranial Pressure Monitoring Cup Catheters	Cordis US Corp.	GWM	Class II	1985-12-27
K854634	Bard Parker Thoracic Vent	BD Becton Dickinson Vacutainer Systems Preanalytic	KDQ	Class II	1985-12-27
K854495	Gresco N.p. Dental Alloy	Gresco Products, Inc.	EJH	Class II	1985-12-27
K854490	Immunoscan Direct Hemophilus Influenzae Type B Tes	American Micro Scan	GRP	Class II	1985-12-27
K854375	Coopervision Acap Power Drive Ultrasonic Anterior	CooperVision, Inc.	HQC	Class II	1985-12-27
K854347	Hybrid Points	Shofu Dental Corp.	DZP	Class I	1985-12-27
K854285	Gdc 1453 Casting Alloy	Deringer-Ney, Inc.	EJH	Class II	1985-12-27
K854225	Allergan I.s.p. Model 3000 Ophthalmic Surgical-Sys	Advanced Medical Technology, Inc.	HQC	Class II	1985-12-27
K854153	Marathon Power Drive-Wheelchair	Everest & Jennings, Inc.	ITI	Class II	1985-12-27
K854147	Battle Creek Boardwalker Electric Treadmill	Battle Creek Equipment	IOL	Class I	1985-12-27
K854116	Phaco Packs, 1A Packs & Pack Components	Medical Corp. of America	HQC	Class II	1985-12-27
K854054	Placido Disc	Cutler Medical Instruments	HLR	Class I	1985-12-27
K854051	Modular Power Base	Everest & Jennings, Inc.	ITI	Class II	1985-12-27
K853967	Hi-Tech Lab Model Concha All in Ear	Hi-Tech Laboratories, Inc.	ESD	Class I	1985-12-27
K853916	P.m. Hip-Femoral Prosthesis	Advanced Biosearch Assn.	JDI	Class II	1985-12-27
K853804	Vicon (Modification)	Oxford Metrics, Inc.	IKN	Class II	1985-12-27