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 2983 of 3529

510(k) clearances, page 2983 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851890	Medtronic 5064	Medtronic, Inc.	DTD	Class II	1985-06-19
K851855	Bio Medicus Bio Pump Model Bp-90	Bio Medicus, Inc.	KFM	Class II	1985-06-19
K851615	Centrimed System 1 W/manual Pump Drive	Centrimed Corp.	DTQ	Class II	1985-06-19
K851614	Centrimed System 1 W/24 Volt Battery Power Supply	Centrimed Corp.	DTQ	Class II	1985-06-19
K851613	Centrimed System 1 W/system 1 Adapter	Centrimed Corp.	KFM	Class II	1985-06-19
K851574	Modifications to Acs Coronary Guiding Catheter W/t	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1985-06-19
K851466	Carnation - Oxygen Mask	Dadsun Corp., Ltd.	BYG	Class I	1985-06-19
K851289	Cobe Gas Filter	Cobe Laboratories, Inc.	KRI	Class I	1985-06-19
K851140	Teleflex Medical Introducer Needle	Teleflexmedical, Inc.	DWS	Class I	1985-06-19
K851133	Terran Biomechanical Analysis System	Terran Biomedical Instruments	LDK	Unclassified	1985-06-19
K851094	Model Bion 1/Type 1084T Car Ionizer	Medicor USA, Ltd.	FRF	Class II	1985-06-19
K851037	Orthotron Muscle Stimulator Mk II Dc	Hodgkinson & Corby, Ltd.	IPF	Class II	1985-06-19
K850980	Crestline Cl in-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1985-06-19
K850791	Mdi 2000 - Pulse Generator	Micromedical Devices, Inc.	DRO	Class II	1985-06-19
K850015	Polymed Lab Arterial Embolectomy Catheter	Polymed Laboratories	DXE	Class II	1985-06-19
K844637	Whiteside Acrylic Cement Spacer Sleeve	Dow Corning Corp. Healthcare Industries Materials	LTC	Class III	1985-06-19
K844480	Dental Oral Care Systems & Components	Advanced Bio Systems, Inc.	EBO	Class II	1985-06-19
K852369	Lidgrer-Lund Acetabular Sockets	Link America, Inc.	JDL	Class III	1985-06-18
K852334	Model Bx Ophthalmoscope(bx-Rp Includes Batte Han)	Design Med. Corp.	HLJ	Class II	1985-06-18
K852267	Electrical Nerve Stimulation(tens) Electrodes	Axelgaard Mfg. Co., Ltd.	GXY	Class II	1985-06-18
K852265	Non-Sterile Gauze Roller Bandages	Leonard Joseph Co.	EFQ	Unclassified	1985-06-18
K852105	Manan Ubk Ultrasonic Guided Biopsy Kit	Manan Manufacturing Co., Inc.	FCH	Class I	1985-06-18
K851981	No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.	Superior Plastic Products Corp.	FOZ	Class II	1985-06-18
K851404	Omnifit Threaded Acetabular Components 2005 Series	Osteonics Corp.	KWA	Class III	1985-06-18
K851254	Micro-Inhaler Model Tv-7000 & Tv-8000	Bioclimatic, Inc.	CCQ	Class I	1985-06-18
K851219	Fill Hose Safety Adapter	Penox Technologies, Inc.	CAM	Class I	1985-06-18
K851217	Penox Dual Flow Minifold	Penox Technologies, Inc.	CAM	Class I	1985-06-18
K851216	Penox Dual Feed Manifold	Penox Technologies, Inc.	CAM	Class I	1985-06-18
K851215	T-Handle Adapter, U-Handle & L Handler Adapter	Penox Technologies, Inc.	CAM	Class I	1985-06-18
K851175	Transcutaneous Electrical Nerve Stimula-Electorde	Medical Devices Inc.	GXY	Class II	1985-06-18
K851097	Lode Model Corival Ergometer	Lode Corp.	ISD	Class II	1985-06-18
K851074	Variable Nebulizer Heater	Travenol Laboratories, S.A.	CAF	Class II	1985-06-18
K851027	Sof. Care Cushion & Sof-Care Cushion Cover	Gaymar Industries, Inc.	KIC	Class I	1985-06-18
K850018	Laserscope Omniplus Photosurgical Sys Nd:yag	Laserscope	GEX	Class II	1985-06-18
K844360	Cordis Multicor S 330A & 331A Cardiac Pacemakers	Cordis US Corp.	DXY	Class III	1985-06-18
K852173	Merivaara Crib Trolley-Model 381	Daun International, Inc.	FMS	Class II	1985-06-17
K852041	Deknatel Thoracic Catheter	Pfizer Inc	JOL	Class II	1985-06-17
K851979	Trocar Catheter	Hospital Products Group	JOL	Class II	1985-06-17
K851519	Fortuna Disposable Syringes	Impor-Tex, Intl., Inc.	FMF	Class II	1985-06-17
K851285	Radial Immunodiffusion Plates Csf Igg & Csf Albumi	Cooper Biomedical, Inc.	DCF	Class II	1985-06-17
K850599	Home Bili Lights-Model 100	Physician Engineered Products, Inc.	LBI	Class II	1985-06-17
K850431	Ez-Detect Visual Color Test for Blood in Stool	Nms Pharmaceuticals, Inc.	KHE	Class II	1985-06-17
K850144	Biological/chemical Indicator Proof Flash	American Sterilizer Co.	FRC	Class II	1985-06-17
K852329	Stand, Operating Room	Scholten Surgical Instruments, Inc.	FOX	Class I	1985-06-14
K852241	Axiom Atraum Trocar Catheter	Axiom Medical, Inc.	GBS	Class I	1985-06-14
K852081	Pennine Oxygen Link Tubing	Pennine Medical, Ltd.	BYX	Class I	1985-06-14
K851939	Corning Certain -Ise	Corning Medical & Scientific	JIX	Class II	1985-06-14
K851892	Compact 2000	Atrium Medical Corporation	KDQ	Class II	1985-06-14
K851717	880/1 to 890/4 Various Types of Perioteal Elevator	Artiberia	EMJ	Class I	1985-06-14
K851685	Digital Gamma Camera Gca 601 E	Toshiba Medical Systems	JWM	Class II	1985-06-14