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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1507 of 3531

510(k) clearances, page 1507 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022455	Spife Ld-12 Kit, Model 3338	Helena Laboratories, Corp.	CFE	Class II	2002-10-01
K022380	Livesire Electrophysiology Catheter	Abbott Medical	DRF	Class II	2002-10-01
K022298	I-Stethos Link	Andromed, Inc.	DQD	Class II	2002-10-01
K022181	Novus Varia Ophthalmic Laser and Delivery Devices with Accessories	Lumenis Ltd	GEX	Class II	2002-10-01
K021495	Qiva	PIE Medical Imaging B.V.	DQK	Class II	2002-10-01
K021454	Unity Network Id	General Electric Medical Systems Information Techn	MWI	Class II	2002-10-01
K021389	Biological Sound Monitor (Bsm) Sensor	Andromed, Inc.	DQD	Class II	2002-10-01
K021142	All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865	Fortune Medical Instrument Corp.	EZL	Class II	2002-10-01
K020807	Afp Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	LOJ	Class II	2002-10-01
K014071	Pmx Disposable Bag Mask Resuscitator	Allied Medical LLC	BTM	Class II	2002-10-01
K011493	Mentor Isoloader Automatic Needle Loading System and Physics Workstation for Brachytherapy	Mentor	KPT	Class II	2002-10-01
K023062	Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management	Abbott Medical	FRN	Class II	2002-09-30
K022922	Harmony Inr Monitoring System	Lifescan, Inc.	GJS	Class II	2002-09-30
K022533	Fastpack Testosterone Calibrator	Qualigen Inc	JIT	Class II	2002-09-30
K022519	Ldl Cholesterol (Automated)	JAS Diagnostics/Drew Scientific	JHM	Class I	2002-09-30
K022512	Cellprep Sample Preparation System, Model 9518	Immunicon Corp.	GKH	Class I	2002-09-30
K022409	Spectral's Cardiac Status Ck-Mb Rapid Test	Spectral Diagnostics, Inc.	JHT	Class II	2002-09-30
K022406	Exel Securetouch Safety Vaculet Blood Collection Set	Exelint Intl. Co.	FMI	Class II	2002-09-30
K022154	Level 356 X-Ray Film Processor, Models Md & Md-D	Fischer Industries, Inc.	IXW	Class II	2002-09-30
K022140	Whisper Wear Breast Pump	Whisper Wear	HGX	Class II	2002-09-30
K013839	Bio-Rad Platelia Toxo Igg Tmb	Bio-Rad	LGD	Class II	2002-09-30
K013837	Bio-Rad Platelia Toxo Igm Tmb	Bio-Rad	LGD	Class II	2002-09-30
K012138	Modification to Acis (Automated Cellular Imaging System)	Chroma Vision Medical Systems, Inc.	MYA	Class II	2002-09-30
K022901	Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc.	JIS	Class II	2002-09-27
K022883	Hrk-63 Knee Array Coil	Mri Devices Corp.	MOS	Class II	2002-09-27
K022851	Ph and Amines External Control Set	Ortho-Clinical Diagnostics, Inc.	JJY	Class I	2002-09-27
K022560	M2 Single Use Microkertome	Moria SA	HMY	Class I	2002-09-27
K022552	Atb All-Terrain Balloon Pta Dilatation Catheter	Cook Inc.	DQY	Class II	2002-09-27
K022424	Replace Ha Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162	Nobel Biocare Uas, Inc.	DZE	Class II	2002-09-27
K022297	Global ECG Management System (Gems)	Cardiocomm Solutions, Inc.	DSH	Class II	2002-09-27
K022115	Capiox Rx05 Hollow Fiber Oxygenator W/without Hardshell Reservoir	Terumo Corp.	DTZ	Class II	2002-09-27
K022103	Puritan-Bennett 700 Renaissance II Spirometry System	Medtronic, Inc.	BZG	Class II	2002-09-27
K021814	Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345	Siemens Healthcare Diagnostics Inc.	MMI	Class II	2002-09-27
K021793	Ebv Ea-D Igg Elisa Kit, Model Ebg-100	Pan Bio Pty., Ltd.	LSE	Class I	2002-09-27
K021266	Endo Window High Frequency Electrocautery Device, Model Ew018	Ethicon Endo-Surgery Inc	KNS	Class II	2002-09-27
K020542	Daytripper Dialysate Warmer	Stickman Industries, Inc.	MLW	Class II	2002-09-27
K013875	Med-Tec Compensator Block Cutter Software	Medtec LLC	IXI	Class II	2002-09-27
K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	DZE	Class II	2002-09-26
K023045	Microrupter V	Meridian AG	LXS	Class II	2002-09-26
K023024	Transvaginal Doppler Probe, Model 09-0006-02	Vascular Control Systems, Inc.	ITX	Class II	2002-09-26
K023020	Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette	Agfa Corp.	IXA	Class II	2002-09-26
K022792	Cashmere Powder Free Latex Examination Gloves (Polymer Coated Online Chlorinated)	Seal Polymer Industries Bhd.	LYY	Class I	2002-09-26
K022522	Pulpdent Putty Dam	Pulpdent Corporation	EIE	Class I	2002-09-26
K022458	Auto*therm 395, Model Me 395	Mettler Electronics Corp	IMJ	Class II	2002-09-26
K022084	Atlas Monitor, Models 200,210,220	Welch Allyn Inc	DQA	Class II	2002-09-26
K021131	Chloraprep	Centrix, Inc.	LBH	Class II	2002-09-26
K020903	Docxs B Series Electrodes	Docxs, LLC	GXY	Class II	2002-09-26
K020457	Axiamed Trans-Sacral Spinal Access Device	Axiamed, Inc.	HRX	Class II	2002-09-26
K023015	Cardis	Schwarzer GmbH	DQK	Class II	2002-09-25
K022992	Reaads Anti-Cardiolipin Igg/igm Semi-Quantitative Test Kit, Model 023-001	Corgenix, Inc.	MID	Class II	2002-09-25