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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3498 of 3526

510(k) clearances, page 3498 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770068	Cannula, Hunter-Sessions, Self-Retain.	Barlow Mfg., Corp.	DWF	Class II	1977-03-01
K761250	Simplate	General Diagnostics	JCA	Class II	1977-03-01
K761157	Aminoglycoside (125I) Ria Kit	Siemens Healthcare Diagnostics Inc.	DJB	Class II	1977-03-01
K760462	Electrical Shock Device	Edward V. Kaufholz, Sr.	IPF	Class II	1977-03-01
K760048	Tray, Urethral Catheterization	M-C Ind., Inc.	FCM	Class II	1977-03-01
K760047	Tray, Bladder Irrigation	M-C Ind., Inc.	EYN	Class II	1977-03-01
K770360	Hearing Aid, Maico Dm Mark 180	Maico Hearing Instruments, Inc.	ESD	Class I	1977-02-28
K770343	Maxicamera II	General Electric Co.	IYX	Class I	1977-02-28
K770341	Temp. Probe, & Electronic Thermometer	Electro-Catheter Corp.	DRF	Class II	1977-02-28
K770340	Bandages, Plaster of Paris & Splints	Johnson & Johnson Professionals, Inc.	ITG	Class I	1977-02-28
K770339	Bandage, Plastic & Sheer	Johnson & Johnson Professionals, Inc.	FPX	Class I	1977-02-28
K770335	Collimator, Automatic	Litton Medical Systems	KPW	Class II	1977-02-28
K770328	Pacemaker, Antrio-Ventricular Seq.	American Pacemaker Corp.	DXY	Class III	1977-02-28
K770323	Veri/trodes	Verite Scientific, Inc.	GXY	Class II	1977-02-28
K770321	Perceptor	Danavox, Inc.	ESD	Class I	1977-02-28
K770309	Hearing Aid, Dm Iros	Maico Hearing Instruments, Inc.	ESD	Class I	1977-02-28
K770308	Hearing Aid, Dm Iros Directional	Maico Hearing Instruments, Inc.	ESD	Class I	1977-02-28
K770268	Sys. for Rec. Bser Responses	Life-Tech Instruments, Inc.	GWJ	Class II	1977-02-28
K770251	Super X Adjustrette	Qualitone	EXD	Class II	1977-02-28
K770230	Karaya Gum Powder	Atlantic Surgical	EZR	Class I	1977-02-28
K770220	Radionuclide Computed Tomography Sys.	G.D. Searle and Co.	KPS	Class II	1977-02-28
K770208	Motorized Operator for Pipetting Dev.	Kensington Scientific	JQW	Class I	1977-02-28
K770154	3-Way Stopcock with Luer-Lock Fitting	American Viggo	KGZ	Class I	1977-02-28
K770095	Platelet Control, Normal & Abnormal	BD Becton Dickinson Vacutainer Systems Preanalytic	JPK	Class II	1977-02-28
K770078	Castle Tec-Test Steam Steri. Integrator	Castle Co.	JOJ	Class II	1977-02-28
K770024	Monitor, Neonatal, Model 78260A	Hewlett-Packard Co.	DRT	Class II	1977-02-28
K770023	Monitor, Neonate, Model 78213A	Hewlett-Packard Co.	DRT	Class II	1977-02-28
K770022	Monitor, Neonatal, Model 78261A	Hewlett-Packard Co.	DRT	Class II	1977-02-28
K761341	Portagas Aerator	Amsco Co.	FLI	Class II	1977-02-28
K761208	Hematrak Maturity Profile Option	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1977-02-28
K761199	Airway Pressure Monitor	Draeger, Inc.	GAP	Class II	1977-02-28
K761192	Dressing Change Kit	Superior Plastic Products Corp.	JOK	Class I	1977-02-28
K761191	4 1/2 Oz. Graduated Specimen Container	Superior Plastic Products Corp.	FMH	Class I	1977-02-28
K761189	Houva-Lite Sole Unit #502	National Biological Corp.	FTC	Class II	1977-02-28
K761188	Houva-Lite Palm Unit #501	National Biological Corp.	FTC	Class II	1977-02-28
K761187	Houva-Lite Leg Unit #701	National Biological Corp.	FTC	Class II	1977-02-28
K761186	Houva-Lite Arm Unit #601	National Biological Corp.	FTC	Class II	1977-02-28
K760810	Tube, Gastro-Enterostomy	Sherwood Medical Industries	EXD	Class II	1977-02-28
K760368	Monitoring & Stress Testing Equipment	Advanced Medical, Inc.	DSI	Class II	1977-02-28
K770286	Ventilator Breathing Circuit	Mcgaw Respiratory Therapy	CAI	Class I	1977-02-25
K770265	Cholesterol Test	Sclavo, Inc.	CHH	Class I	1977-02-25
K770257	Hood & Beard Cover, Clarion Surgeon's	Sherwood Medical Industries	FXY	Class II	1977-02-25
K770255	Lc-65T Detector and Oven	Revvity Health Sciences, Inc.	KZR	Class I	1977-02-25
K770236	Sauvage Filamentous Prostheses	Usci, Div. C.R. Bard, Inc.	DSY	Class II	1977-02-25
K770149	Major Suture Removal Tray	Pharmaseal Div., Baxter Healthcare Corp.	KDD	Class I	1977-02-25
K770096	Epidural Block Procedure Pack	American Viggo	CAZ	Class II	1977-02-25
K770056	Gloves, Surgeons,micro-Touch Powderfree	Arbrook Mfg. Corp.	KGO	Class I	1977-02-25
K770365	Radioimmunoassay Digoxin Test, in Vitro	Travenol Laboratories, S.A.	DPO	Class II	1977-02-24
K770332	Amplifier, Photopulse, Model Pa13	Medsonics	JOM	Class II	1977-02-24
K770330	Monitor, Pulse Wave Velocity P607	Cyborg Corp.	DXG	Class II	1977-02-24