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 1790 of 3531

510(k) clearances, page 1790 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K983391	Immulite 2000 Om-Ma Model L2kop2	Siemens Healthcare Diagnostics Inc.	LTK	Class II	1998-10-15
K982879	Shield Diastat Anti-B2 Glycoprotein 1 Igg (Elisa) Assay	Shield Diagnostics, Ltd.	MSV	Class II	1998-10-15
K982872	Tg Medical Powder-Free Latex Examination Glove Protein Labeling Claim (50 Micrograms or Less)	TG Medical Sdn Bhd	LYY	Class I	1998-10-15
K982785	Film Digitizer Model 2905	Array Corp.	LMA	Class II	1998-10-15
K982772	Signa Profile Quadrature Thoracic/lumbar Spine Phased Array Coil	GE Healthcare	MOS	Class II	1998-10-15
K982680	Chiron Diagnostics Corporation Acs: Centaur Br Immunoassay	Chiron Diagnostics Corp.	MOI	Class II	1998-10-15
K982658	Ksea Endoscopes for Dental Procedures	Karl Storz Endoscopy-America, Inc.	EIA	Class I	1998-10-15
K982606	Aurofluid Cpf	Metalor Dental USA Corp.	EJT	Class II	1998-10-15
K982492	Imcor Dental Implant System Accessories	Imcor	DZE	Class II	1998-10-15
K982220	Model 2872 Bipolar Lead Adaptor Kit	Medtronic, Inc.	DTD	Class II	1998-10-15
K982209	Accuclot Thrombin Time Reagent Model A8713/a4589	Sigma Diagnostics, Inc.	GJA	Class II	1998-10-15
K981888	Smoke-Evac	Bio-Medical Devices, Inc.	GEI	Class II	1998-10-15
K981565	Bioclear Concentrate	Waggoner Product Development	EIA	Class I	1998-10-15
K981360	Vinyl Patient Examination Glove, Powdered	Glormed Intl., Inc.	LYZ	Class I	1998-10-15
K982935	Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator	Siemens Healthcare Diagnostics Inc.	KXT	Class II	1998-10-14
K982487	Cpt, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, Cpt, Inc. Meteor Hand Held Respiratory Mechanics Mo	Cardiopulmonary Technologies, Inc.	BZC	Class II	1998-10-14
K982479	Excel Ambulatory EEG	Excel Tech., Ltd.	GWQ	Class II	1998-10-14
K982470	ECG Electrodes Apron	Tapuz Medical Technology, Ltd.	DRX	Class II	1998-10-14
K981744	Combination Toa with Nasal Mask Holder and Universal Nasal Mask Holder	W. Keith Thornton, D.D.S.	BZD	Class II	1998-10-14
K981697	Cambridge Heart Ch 2000 Cardiac Diagnostic System	Cambridge Heart, Inc.	DPS	Class II	1998-10-14
K981119	Cardiopal Model Number Pm20	Medicomp, Inc.	DXH	Class II	1998-10-14
K974713	Bard Hydrophillic Coated Guide Wire	C.R. Bard Inc	DQX	Class II	1998-10-14
K973198	Vgf-7 Vascular Graft Flowmeter	Medicard, Ltd.	DPW	Class II	1998-10-14
K983175	Extra-Care Powder-Free Examination Glove	Ultrawin Sdn Bhd	LYY	Class I	1998-10-13
K983056	Innovasive Tibial Fastener	Innovasive Devices, Inc.	MBI	Class II	1998-10-13
K982982	Mini-Fixator for Colles Fractures	Zimmer GmbH	HRS	Class II	1998-10-13
K982939	Btf Thin Film Wound Dressing	Bioderm, Inc.	MGP	Unclassified	1998-10-13
K982871	Drug Calibrator II	Siemens Healthcare Diagnostics Inc.	DKB	Class II	1998-10-13
K982688	Spectrum Designs Pre-Form Contour Silicone Carving Block	Spectrum Designs, Inc.	MIB	Class II	1998-10-13
K981841	Breathe Easy, Models Ad and Cd	Respiraid, Ltd.	FRF	Class II	1998-10-13
K981709	Coagulation Factor V Deficient Plasma	Siemens Healthcare Diagnostics Inc.	GJT	Class II	1998-10-13
K981645	Titanium Hemostatic Clip	Vitalitec Int'l., Inc.	FZP	Class II	1998-10-13
K981634	Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls	Biocircuits Corp.	LTJ	Class II	1998-10-13
K980820	Philips Easyguide	Philips North America LLC	HAW	Class II	1998-10-13
K974892	Acutek's Hydrocolloid Wound Dressing, Tib 197012	Acutek Adhesive Specialties, Inc.	MGP	Unclassified	1998-10-13
K974890	Acutek's Hydrocolloid Wound Dressing, Tib 997002	Acutek Adhesive Specialties, Inc.	MGP	Unclassified	1998-10-13
K983492	Boehringer Mannheim Elecsys Presicontrol Cardiac	Boehringer Mannheim Corp.	JJY	Class I	1998-10-09
K983387	Ontrak Testcup and Teststik Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1998-10-09
K983327	Active ECG Electrodes Magnetom Vision Systems	Siemens Medical Solutions USA, Inc.	LNH	Class II	1998-10-09
K983211	Centauri	Premier Laser Systems, Inc.	GEX	Class II	1998-10-09
K983162	Peri-Guard, Cv Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc	Bio-Vascular, Inc.	FTM	Class II	1998-10-09
K982895	Sternomega Compomer Cement	Sterngold/Implamed	EMA	Class II	1998-10-09
K982814	Medrad Vistron CT Injector System	Medrad, Inc.	DXT	Class II	1998-10-09
K982691	Multi-Comfort Powdered Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)	Perusahaan Intan Emas Sdn. Bhd.	LYY	Class I	1998-10-09
K982687	Disposable Vinyl Exam Gloves, Powdered	Shanghai Antares Industries, Inc.	LYZ	Class I	1998-10-09
K982441	Cca-220	Benson Medical Instruments Co.	EWO	Class II	1998-10-09
K982428	Christoudias Gauze Dissector (Laparoscopic Hand Instrument)	Innervision, Inc.	HET	Class II	1998-10-09
K982412	Modification of Crit-Line Monitor III (Clm III)	In-Line Diagnostics Corp.	MQS	Class II	1998-10-09
K981597	Radionics Slice Editor Imaging Software Utility	Radionics, Inc.	IYE	Class II	1998-10-09
K981591	Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent	International Regulatory Consultants	FAD	Class II	1998-10-09