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 1425 of 3531

510(k) clearances, page 1425 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032598	Synergetics Synerlight Fiber Optic Lightsource	Synergetics Inc	MPA	Class II	2003-11-24
K031419	Gri-Flex, Models 1000Ml, 500Ml, 250Ml, 100Ml	Laboratorios Grifols, S.A.	KPE	Class II	2003-11-24
K030263	Immunicon Celltracks Analyzer	Immunicon Corp.	GKZ	Class II	2003-11-24
K033565	Lmt Nomag Ic 1,5	Lmt Lammers Medical Technology GmbH	FPL	Class II	2003-11-21
K033444	Philips Medical Systems, M3012a- Hemodynamic Extension to the Multi-Measurement Server	Philips North America LLC	MHX	Class II	2003-11-21
K033441	Boston Scientific 6F Runway Guide Catheter	Boston Scientific Corporation	DQY	Class II	2003-11-21
K033314	Protege Gps Self-Expanding Nitinol Stent and Delivery System	Medtronic, Inc.	FGE	Class II	2003-11-21
K033041	Acon Quik-Check II Home Pregnancy Test Strip	Acon Laboratories, Inc.	LCX	Class II	2003-11-21
K033022	Protemp 3 Garant	3M Espe AG Dental Products	EBG	Class II	2003-11-21
K032992	Unimark Home Pregnancy Test Device	Biotech Atlantic, Inc.	LCX	Class II	2003-11-21
K032849	Aeroneb Go Nebulizer, Model Ag-Ag2000	Aerogen Ltd.	CAF	Class II	2003-11-21
K032665	Olympus Lyophilized Calibrator, Models Dr0070 and Dr0071	OLYMPUS Corporation of the Americas	JIX	Class II	2003-11-21
K031876	Electro Flo Percussor, Model 5000	Med Systems	BYI	Class II	2003-11-21
K031842	Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	PDU	Class II	2003-11-21
K030644	Contec Duo, Contec Lc, Contec Lcr	Dentaurum Inc.	DYH	Class II	2003-11-21
K033593	Reprocessed Single Use Devices Biopsy Forceps	Clearmedical, Inc.	NLU	Class II	2003-11-20
K033502	Lightspeed 6.0 CT Scanner System	GE Healthcare	JAK	Class II	2003-11-20
K033501	Modification to Calibrator for Automatic Systems (Cfas)	Roche Diagnostics GmbH	JIX	Class II	2003-11-20
K033438	Bruno Electra-Ride Elite, Model Sre-2000	Bruno Independent Living Aids, Inc.	ILK	Class II	2003-11-20
K033431	Lso Pet/ct Hirez and Lso Pet/ct 16 Hirez	Siemens Medical Solutions USA, Inc.	KPS	Class II	2003-11-20
K033401	Modification to Resqpod Circulatory Enhancer	Advanced Circulatory Systems, Inc.	BWF	Class II	2003-11-20
K033237	Vascular Solutions Vari-Lase Endovenous Laser Console	Vascular Solutions LLC	GEX	Class II	2003-11-20
K033057	Deroyal Surgical Gowns, Sterile, Non-Sterile	Deroyal	FYA	Class II	2003-11-20
K033035	Tlc Models Ulk-H and Ult-H Infrared Lamps	Tlc Marketing, Inc.	ILY	Class II	2003-11-20
K032995	Sss, Model 1072001 (Standard 4-Hole Model) & 1072002 (Standard 2-Hole Model)	Micron Corp.	ELC	Class II	2003-11-20
K032940	Brightway Brand Latex Examination Glove-(Powder Free, Sterile) Containing 50 Ugm or Less of Water Extractable Protein Pe	Brightway Holdings Sdn. Bhd.	LYY	Class I	2003-11-20
K032938	Brightway Brand Latex Examination Glove-(Powdered, Sterile), Containing 150 Ugm or Less of Water Extractable Protein per	Brightway Holdings Sdn. Bhd.	LYY	Class I	2003-11-20
K032935	Epi-Scan, Model P 100	Edx Epi-Scan, Inc.	GZO	Class II	2003-11-20
K032908	Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Fuguan Plastic Products Co., Ltd.	LYZ	Class I	2003-11-20
K032907	Fuguan (Brand) Powdered Vinyl Patient Examination Gloves	Shijiazhuang Fuguan Plastic Products Co., Ltd.	LYZ	Class I	2003-11-20
K032895	Bi-Angular Shoulder System	Zimmer GmbH	MBF	Class II	2003-11-20
K032787	Neurolase, Models 150V, 150C, 1064	Spectrum Laser & Technologies	ILY	Class II	2003-11-20
K032739	Ucr Spinal System	Seaspine, Inc.	MNI	Class II	2003-11-20
K032708	Plastalgin and Plastalgin Ortho	Septodont	ELW	Class II	2003-11-20
K032613	Temporary Transvenous Pacemaker Placement Assist Device	Peter M. Rothenberg, M.D.	LDF	Class II	2003-11-20
K032379	Quasar, Model Md21	Quantum Skincare, Inc.	ILY	Class II	2003-11-20
K032331	Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)	Black Forest Medical GmbH	HBL	Class II	2003-11-20
K032286	Calcigen Psi Bone Graft Substitute	Biomet Orthopedics, Inc.	MQV	Class II	2003-11-20
K032260	Aramis II Dermatological Laser	Quantel Medical	GEX	Class II	2003-11-20
K031676	Homechoice Apd Set with Lineo Connector, Models 5C4469q, 5C4468q, 5C4531q, 5C8302q, 5C4599q	Baxter Healthcare Corporation	KDJ	Class II	2003-11-20
K031493	Growth Guidance Plate	University of Utah/School of Medicine	HRS	Class II	2003-11-20
K031375	Besmed Various Models of Powered Muscle Stimulator, Be-560/Be-580	Besmed Health Business Corporation	IPF	Class II	2003-11-20
K030978	Scorpio Nrg Knee System	Howmedica Osteonics Corp	JWH	Class II	2003-11-20
K030958	Oria Spinal System, Domino and Tube Connectors	Ortho Tec, LLC	MNI	Class II	2003-11-20
K023874	System 100 Ultrafiltration Catheter	Chf Solutions, Inc.	KDI	Class II	2003-11-20
K023537	Non-Sterile Powder Free Green Latex Patient Exam Gloves with Surface Coating & Protein Labeling Claim (<50Ug/dm2)	Sgmp Co., Ltd.	LYY	Class I	2003-11-20
K023452	Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves with Nopal & Vitamin E	Canopus Medical Supply Co., Ltd.	LYZ	Class I	2003-11-20
K022750	Plv Continuum Ventilator, Model P1000	Respironics, Inc.	NOU	Class II	2003-11-20
K033486	Ge Precision Mpi	NRT X-Ray a/S	OWB	Class II	2003-11-19
K033443	Speedlyser Infusion Catheter Kit	Boston Scientific Corporation	QEY	Class II	2003-11-19