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 1793 of 3531

510(k) clearances, page 1793 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982113	Umeco Optima 694 Ruby Laser System	Umeco, Inc.	GEX	Class II	1998-09-30
K982020	Metron Qa-Ids i.v. Pump Tester	Metron U.S., Inc.	FRN	Class II	1998-09-30
K981876	Synthetic Examination Glove, Powdered	Hsing YI Plastics Processing Co, Ltd.	LYZ	Class I	1998-09-30
K981711	Sysmex Automated Coagulation Analyzer Ca-500	Siemens Healthcare Diagnostics Inc.	JPA	Class II	1998-09-30
K981337	Digital Clinical Thermometer, Models St-833A & St-834A	Mesure Technology Co., Ltd.	FLL	Class II	1998-09-30
K980839	Avocet Pt	Avocet Medical, Inc.	JPA	Class II	1998-09-30
K974170	Duostar	Mti Corp./ Electrostar S.A.-Haiti	GEI	Class II	1998-09-30
K973447	Omniflator 6630(6-630-00)	Northgate Technologies Inc.	HIF	Class II	1998-09-30
K973203	Thymostat Elisa for the Detection of Human Igg,m and a Anti-Rabbit Igg Antibodies	Sangstat Medical Corp.	DAK	Class II	1998-09-30
K972866	Hemochron Jr. Miocrocoagulation Citrated Pt	Accriva Diagnostics, Inc.	GJS	Class II	1998-09-30
K972675	CO2 Gas Warming Unit (6-800-00)	Northgate Technologies Inc.	HIF	Class II	1998-09-30
K972140	A1 Acoustic Rhinometer	G.M. Instruments Ltd.	BXQ	Class II	1998-09-30
K983241	Aso/crp/rf Controls for Immunoturbidimetric Assays	Kamiya Biomedical Company, LLC	JJY	Class I	1998-09-29
K983130	Liquid Immunology Controls for Immunoturbidimetric Assays	Kamiya Biomedical Company, LLC	JJY	Class I	1998-09-29
K982993	Philips Omnidiagnost	Philips North America LLC	OWB	Class II	1998-09-29
K982983	Lsvp International Biopsy Forceps	Lsvp Intl., Inc.	EOQ	Class II	1998-09-29
K982446	Dynamic Shielding Radiation Table	American Biophysics, Inc.	JAI	Class II	1998-09-29
K981834	Perception Inc, Gps-6Tbmd Diagnostic Ultrasound System	Perception, Inc.	IYN	Class II	1998-09-29
K981553	Automated Medical Report Writer	Woodson and Associates, LLC	KPS	Class II	1998-09-29
K981306	Diamedix Is-Hsv 1 & 2 Igg Test System	Diamedix Corp.	LGC	Class II	1998-09-29
K981055	Xknife-4	Radionics, Inc.	IYE	Class II	1998-09-29
K974901	Hybrid Capture System Cmv DNA Assay	Qiagen	LJO	Class II	1998-09-29
K974813	Combison 530D with Power Doppler Mode	Medison America, Inc.	IYN	Class II	1998-09-29
K983147	Accusign Doa 8, Accusign Doa 8 Panel, Accusign Thc/opi/coc/amp/bzo/bar/tca/pcp, Biosign Doa 8, Biosign Thc/opi/coc/amp/p	Princeton BioMeditech Corp.	DKE	Class II	1998-09-28
K983131	Ast	Abbott Medical	CIT	Class II	1998-09-28
K982382	Cobas Integra Reagent Cassettes	Roche Diagnostic Systems, Inc.	CFN	Class II	1998-09-28
K981867	Is-Vzu Igg Test System	Diamedix Corp.	LFY	Class II	1998-09-28
K981817	Coamatic Plasmin Inhibitor	Instrumentation Laboratory Co.	GGP	Class II	1998-09-28
K981394	Braemar Er700 Series Ambulatory ECG Event Monitor Models Er710,er720	Braemar Manufacturing, LLC	DXH	Class II	1998-09-28
K981226	Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3	Dako Diagnostics, Ltd.	GQP	Class I	1998-09-28
K980997	Pgk Device (Modified)	Pgk, Inc.	IWJ	Class I	1998-09-28
K983152	Osteonics Spinal System 5.5Mm & 10.0Mm Bone Screws	Osteonics Corp.	MNH	Class II	1998-09-25
K983123	Poc ENT Endoscope - Sinuscope	Precision Optics Corp.	EOB	Class II	1998-09-25
K982842	Humapen and Humapen Ergo	Eli Lilly and Company, Pharmaceutical Delivery Systems	FMF	Class II	1998-09-25
K982719	The Bone Tie	Surgicraft, Ltd.	HTY	Class II	1998-09-25
K982481	A&d Medical Ua-767Pc Digital Blood Pressure Monitor	A and D Engineering, Inc.	DXN	Class II	1998-09-25
K982330	Depuy Orthotech Restore Orthobiologic Soft Tissue Implant	Depuy, Inc.	FTM	Class II	1998-09-25
K982304	Devilbiss Suction Unit	Sunrise Medical Hhg, Inc.	JCX	Class II	1998-09-25
K982300	Transview (Transmission System),model Ndtr-701A	Toshiba America Medical Systems, In.C	KPS	Class II	1998-09-25
K982279	Vital Signs Monitor; Advisor Model # Bci 9200	Bci Intl., Inc.	MHX	Class II	1998-09-25
K982266	Hydrocision Arthrojet System	Hydrocision, Inc.	HRX	Class II	1998-09-25
K981940	Multapump Disposable Pump Head and Accessories	Dexide, Inc.	GCJ	Class II	1998-09-25
K981299	Silverlon Contact Wound Dressing	Argentum International, LLC	FRO	Unclassified	1998-09-25
K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5Rg05, 5Rg10, 5Rg15, 5G15l, 5Rg20, 5Rg30, 5Rg30l	Interpore Intl.	MQV	Class II	1998-09-25
K973637	Press-Mate Advantage	Colin Medical Instruments Corp.	DXN	Class II	1998-09-25
K971924	Blunt Syringe Cannula	B.Braun Medical, Inc.	FMI	Class II	1998-09-25
K983176	Elecsys Myoglobin Stat Assay	Boehringer Mannheim Corp.	DDR	Class II	1998-09-24
K982954	Free T4 Microwell Eia, Model #7019	Biomerica	CEC	Class II	1998-09-24
K982230	Lasette Laser Skin Perforator	Cell Robotics, Inc.	GEX	Class II	1998-09-24
K982172	Cyto-Stat Cd3-Fitc/cd56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/coulter Clone Msiggi-Rd1/msiggi-Fitc Isotypic Col	Coulter Corp.	GKZ	Class II	1998-09-24