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 2839 of 3529

510(k) clearances, page 2839 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864735	A-TENS - Model Ai-87	American Imex	GZJ	Class II	1987-02-20
K864672	Phonic Ear Models Pe 811Cs and Pe 811Cst	Phonic Ear, Inc.	ESD	Class I	1987-02-20
K864580	Model El-1 W/st Monitor Option (Acronym = Eli/stm)	Mortara Instrument, Inc.	DPS	Class II	1987-02-20
K864388	Modified Disposable Sterile Towel Used in Surgery	DeRoyal Industries, Inc.	KKX	Class II	1987-02-20
K864320	Sentron Pressure Measuring Cath/pressure Interface	Cordis US Corp.	DRQ	Class II	1987-02-20
K864259	Modified Laserflo Blood Perfusion Monitor	Tsi, Inc.	DPW	Class II	1987-02-20
K864095	Engstrom Edith Models 500,1000,1500 & 1500F	Gambro, Inc.	BYD	Class I	1987-02-20
K863469	Codetron Transcutaneous Electrical Nerve Stimula.	Cordis US Corp.	GZJ	Class II	1987-02-20
K863377	Mr338 Servo Heated Delivery Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1987-02-20
K870563	X-Ray Apron	X-Tech, Ltd.	EAJ	Class I	1987-02-19
K870536	Gem Orthodontic Bracket	Ormco Corp.	EJF	Class I	1987-02-19
K870334	Boston Post Cement	Scientific Pharmaceuticals, Inc.	EMA	Class II	1987-02-19
K870209	Nexadent (Dental Cement)	Bionexus, Inc.	EMA	Class II	1987-02-19
K870177	Endobrush	C & S Microinstruments, Ltd.	EKS	Class I	1987-02-19
K870148	Dura Ortho Acrylic	Reliance Dental Mfg., LLC	EBI	Class II	1987-02-19
K870130	Den-Mat Secure Anti-Rotational Post-Core System	Den-Mat Corp.	ELR	Class I	1987-02-19
K865090	Pregelled Dispos. Electrode,silver-Silver Chloride	Labeltape Meditect, Inc.			1987-02-19
K865031	Electrocardiograph	Nihon Kohden America Inc	DPS	Class II	1987-02-19
K865028	Espe Chelon-Silver	Espe GmbH (US)	EBF	Class II	1987-02-19
K865025	Austenal Condensing Instrument	Austenal Dental, Inc.	EKG	Class I	1987-02-19
K865013	Astra T2, T4 and T6	Cardiac Pacemakers, Inc.	DXY	Class III	1987-02-19
K864996	Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30	Dentsply Intl.	ELC	Class II	1987-02-19
K864978	Appliscope	Grandcor Medical Systems	DPS	Class II	1987-02-19
K864962	Oberto Mouth Prop	Medovations, Inc.	JXL	Class II	1987-02-19
K864940	Numed Balloon Angiographic Catheters	Numed Inc	DQO	Class II	1987-02-19
K864922	Dental Handpieces and Attachment	E&D Dental Manufacturing Co.	EKS	Class I	1987-02-19
K864895	Intersept* Cardiotomy Reservoir with Filter	Johnson & Johnson Professionals, Inc.	DTN	Class II	1987-02-19
K864890	Stockert-Shiley Caps Venous Occlusion Clamp	Shiley, Inc.	KRI	Class I	1987-02-19
K864787	Schneider-Shiley Guide Wire	Shiley, Inc.	DQX	Class II	1987-02-19
K864703	Modified Gas-Stat(tm) Monitoring System	Cardiovascular Devices, Inc.	DTY	Class II	1987-02-19
K864700	Q700 Electrocardiograph	Quinton, Inc.	DPS	Class II	1987-02-19
K864565	Monabrite Cytomegalovirus (Cmv) Ifa Kit	Serono Diagnostics, Inc.	GQH	Class II	1987-02-19
K864561	Derata Medi-Jector IV	Derata Corp.	KZE	Class II	1987-02-19
K864058	Amplatz Moveable Core Guidewire	Lake Region Mfg., Inc.	DQX	Class II	1987-02-19
K863891	Modified Stbp-680	Quinton, Inc.	DXN	Class II	1987-02-19
K863740	Rmi Femoral Venous Drainage Cannula	Research Medical, Inc.	DWF	Class II	1987-02-19
K862808	Bioma 2000	E.B.S., Inc.	DXG	Class II	1987-02-19
K862557	Austenal Acusoft Soft Liner	Austenal Dental, Inc.	EBI	Class II	1987-02-19
K862261	Kontron Supermon Cardiac Output Module 7263	Kontron Instruments, Inc.	DXG	Class II	1987-02-19
K855247	Interoperative Linear/sector Ultrasound Scanner	Cerenovus, Inc.	ITX	Class II	1987-02-19
K854371	Mtc 6210A Cardiac Output Computer	Nihon Kohden America Inc	DXG	Class II	1987-02-19
K870277	Monitorx Laserx Theophylline Reagent Set	American Monitor Corp.	LGS	Class II	1987-02-18
K870246	Reflotron(r) Ast (Got)	Boehringer Mannheim Corp.	CIT	Class II	1987-02-18
K865096	New Second French Size Mahurkar Catheter	Quinton, Inc.	LFK	Class II	1987-02-18
K865053	Sera-Tek Microsomal Antibody Test	Miles Laboratories, Inc.	JZO	Class II	1987-02-18
K864969	Jms Halo Application Tray	Jerome Medical	KDD	Class I	1987-02-18
K864838	Simultrac Free T4[57co]/tsh Mab[125i]	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1987-02-18
K864530	Seralyzer Glucose (Hk) Reagent Strips,module,cali.	Miles Laboratories, Inc.	CGA	Class II	1987-02-18
K864509	Spark-Kit(tm)	Lyphomed, Inc.			1987-02-18
K870446	Dolphin Umbilical Cord Clamp	Andermac, Inc.	HFW	Class II	1987-02-17