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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3146 of 3528

510(k) clearances, page 3146 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831879	Universal Level Sensor	3M Health Care, Sarns	DTW	Class II	1983-07-26
K831827	Egg Yolk Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1983-07-26
K831767	Implantable Cardiac Pacing Leads	Oscor Inc.	DTB	Class III	1983-07-26
K831750	Pm-3	Delta Medical Industries	DXS	Class II	1983-07-26
K831741	Flurazepam Toxicology Control	Utak Laboratories Inc	DIF	Class I	1983-07-26
K831738	Caffine Toxicology Control	Utak Laboratories Inc	LAS	Class I	1983-07-26
K831735	Maprotiline	Utak Laboratories Inc	LAS	Class I	1983-07-26
K831734	Amoxapine 8-Hydro-Xyamoxapine	Utak Laboratories Inc	DIF	Class I	1983-07-26
K831658	Microelisa Comp	bioMerieux, Inc.	LIB	Class I	1983-07-26
K831645	Temp. Bipolar Epicardial Lead	Cordic Corp.	LDF	Class II	1983-07-26
K831643	Stripreader Microelisa System	bioMerieux, Inc.	LIB	Class I	1983-07-26
K831642	Heating Block Microelisa System	bioMerieux, Inc.	LIB	Class I	1983-07-26
K831474	Mini Pulsator	Medelco, Ltd.			1983-07-26
K831473	Ultra Pulsator Mf	Medelco, Ltd.	IPF	Class II	1983-07-26
K831472	Ultra Pulsator	Medelco, Ltd.			1983-07-26
K831395	Avl 0073 Microsampler	Avl Scientific Corp.	FMI	Class II	1983-07-26
K831384	Coaxial Balloon Urethral Dilator	Thomas J. Fogarty, M.D.	FAH	Class II	1983-07-26
K831296	Polychaco Fia-ABS Test for Syphilis	Parasitic Disease Consultants	JWL	Class II	1983-07-26
K831293	Solarcryl Custom Tray Material	Solar Dental Co., Inc.	EBH	Class I	1983-07-26
K831271	Elt-8/Ds Hematology Analyzer & Lysrig	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1983-07-26
K831246	Whistler in-Line Pressure Release Valve	Airlife, Inc.	CBP	Class II	1983-07-26
K831240	Laser Bronchoscope	Eder Instrument Co, Inc.	EOQ	Class II	1983-07-26
K830903	Cardio Arrhythmia Transmitter C.a.t	Cardio Technology, Ltd.	DXH	Class II	1983-07-26
K830764	Fr Root Canal Sealer	Shizai Corp.	EKA	Class I	1983-07-26
K822883	Herpelisa Kit	M.A. Bioproducts	LGC	Class II	1983-07-26
K822770	Burlington Stockinette	Balfour, Inc.			1983-07-26
K831864	Uric-Acid Test Enzymatic Colorimetric	Stanbio Laboratory	KNK	Class I	1983-07-22
K831863	Cholesterol-Enzymatic Reagent Set	Stanbio Laboratory	CHH	Class I	1983-07-22
K831858	Triglycerides Reagent Set	Stanbio Laboratory	CDT	Class I	1983-07-22
K832145	Monoblock Prostoperative TENS Electrode	New Dimensions in Medicine, Inc.	GXY	Class II	1983-07-19
K832107	Leg Bag Extention Tube-Sterile	Plasco, Inc.	KNX	Class II	1983-07-19
K832106	External Incontinence Catheter Travel	Plasco, Inc.	KNX	Class II	1983-07-19
K832086	Use 77 Ultrasonic Nebulizer	Medlog GmbH Marketing Services	CAF	Class II	1983-07-19
K832048	Astra Systems Enzyme Module Ld-P	Beckman Instruments, Inc.	CFJ	Class II	1983-07-19
K831980	Emit Serum Tricyclic Antidepress Calibra	Syva Co.	DLJ	Class II	1983-07-19
K831979	Emit Serum Tricyclic Antidepress. Contro	Syva Co.	LAS	Class I	1983-07-19
K831960	Test for Human Alpha One Acid Glyco-	Kent Laboratories, Inc.	LKL	Class I	1983-07-19
K831959	Radial Immuno-Test for Human Factor B	Kent Laboratories, Inc.	JZH	Class II	1983-07-19
K831958	Radial Immuno-Test for Human C-Reacti	Kent Laboratories, Inc.	DCK	Class II	1983-07-19
K831953	Infusion Pump	Cryosan, Inc.	FIR	Class II	1983-07-19
K831939	Tall Floor Stand Tfs-01	Sorensen Research	GCX	Class II	1983-07-19
K831933	Theophylline Aca Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1983-07-19
K831920	Plastic Tubing Connectors	Polymer Technology Corp.	BYY	Class II	1983-07-19
K831907	Rabbit Antiserum to Human Igm	Dako Corp.	DFS	Class II	1983-07-19
K831906	Rabbit Antiserum to Human C4	Dako Corp.	DBI	Class II	1983-07-19
K831904	Rabbit Antiserum to Human Kappa Light	Dako Corp.	DEO	Class II	1983-07-19
K831903	Fluorescein Conjugated Immunoglobulin	Dako Corp.	DES	Class II	1983-07-19
K831898	Scolimeter	Dr. Micheal A. Sabia	KTZ	Class I	1983-07-19
K831850	Neuro-Pulser 2 Transcutan. Elec. Nerve	Th Charters, Inc.	GZJ	Class II	1983-07-19
K831798	Disposable Scalpels	I M, Inc.	KDC	Class I	1983-07-19