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 1559 of 3531

510(k) clearances, page 1559 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012547	Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Solution	Di-Chem, Inc.	KPO	Class II	2002-01-18
K012511	Waterlase Millennium	Biolase MG LLC	MXF	Class II	2002-01-18
K012328	Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder	Di-Chem, Inc.	KPO	Class II	2002-01-18
K012293	Vascular Solutions Duett Flowable Hemostat	Vascular Solutions LLC	QSX	Unclassified	2002-01-18
K011846	Biotech Powered Wheelchair, C650pw	Roc Chinese-European Industrial Research Society	ITI	Class II	2002-01-18
K010549	Biliary and Pancreatic Endoprostheses (Stents)	Medi-Globe GmbH	FGE	Class II	2002-01-18
K014234	Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed Nd: Yag Laser	Continuum Electro-Optics, Inc.	GEX	Class II	2002-01-17
K014225	Breathtek - Ubit Ubt for H. Pylori	Meretek Diagnostics, Inc.	MSQ	Class I	2002-01-17
K014213	Siemens Infinity Gateway Suite	Siemens Medical Solutions USA, Inc.	MHX	Class II	2002-01-17
K014212	Bard Conquest Pta Balloon Dilatation Catheter	C.R. Bard Inc	DQY	Class II	2002-01-17
K014194	Modification to Ebi Xfix Vision Fixation System	Ebi, LLC	KTT	Class II	2002-01-17
K014157	Heartstreamfr2 AED with M3848a and M3849a, Models M3860a, M3861, M3840a, M3841a	Philips North America LLC	MKJ	Class III	2002-01-17
K014148	Self-Drilling Radiographic Marker	Biomet Microfixation	NEU	Class II	2002-01-17
K014145	Modification to Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Model 8130, 8131	Interpore Cross Intl.	MQP	Class II	2002-01-17
K014136	Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology	Sulzer Intratherapeutics, Inc.	FGE	Class II	2002-01-17
K014062	Simplicity Easy Access Infusion Set	Sterling Medivations, Inc.	FPA	Class II	2002-01-17
K014061	Simplicity Starplus Soft Infusion Set	Sterling Medivations, Inc.	FPA	Class II	2002-01-17
K013870	Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224	Smith & Nephew, Inc.	HIH	Class II	2002-01-17
K013841	3Dfis, Model Ies-Fl-101	3Dsharp, Inc.	LLZ	Class II	2002-01-17
K013835	Global Healthcare Vaginal Speculum	Dynascend Consulting Int'L, LLC	HIB	Class II	2002-01-17
K013625	Permacol	Tissue Science Laboratories, PLC	FTM	Class II	2002-01-17
K013583	Rossmax Medipro Model 10 and 60, Medicare Model 10 and 60 Blood Pressure Monitors	Rossmax International Ltd.	DXN	Class II	2002-01-17
K013571	Magicfil	Dmg USA, Inc.	EBF	Class II	2002-01-17
K013554	Polymer Coated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)	Maxter Glove Manufacturing Sdn Bhd	LYY	Class I	2002-01-17
K013539	Rossmax Medipro, Models 100F, 200F, and 300F Blood Pressure Monitors	Rossmax International Ltd.	DXN	Class II	2002-01-17
K013519	Simple	Bisco Inc	KLE	Class II	2002-01-17
K013513	Dekompressor Percutaneous Lumbar Discectomy Probe	Pain Concepts, Inc.	HRX	Class II	2002-01-17
K013498	Chlorinated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)	Maxter Glove Manufacturing Sdn Bhd	LYY	Class I	2002-01-17
K013490	Cemented Calcar Hip System	Encore Orthopedics, Inc.	LPH	Class II	2002-01-17
K013485	Microlife Upper Arm Automatic Blood Pressure Monitor, Model Bp-3Bto-1, with Optional Thermal Printer, Model Pr 1Ka1	Microlife Corp.	DXN	Class II	2002-01-17
K013477	Toco Lite, Model Td-01	Ventrex, Inc.	HFM	Class II	2002-01-17
K013461	Nlite System,model A00-1025	Icn Photonics, Ltd.	GEX	Class II	2002-01-17
K013460	Swift Low Profile Cup (Pro Cup)	Swift Delivery Products	HDB	Class II	2002-01-17
K013459	Modification of Nc-Stat	Neurometrix, Inc.	JXE	Class II	2002-01-17
K012884	Dilating Tip Obturator	Applied Medical Resources Corp	GCJ	Class II	2002-01-17
K012879	Exel Huber Infusion Set with Needleless Injection Site	Exelint Intl. Co.	FPA	Class II	2002-01-17
K012804	Plagiocephalic Applied Pressure Orthosis P.a.p. Orthosis	Scott E Allen CP	MVA	Class II	2002-01-17
K012789	Modified to Ldl/hdl Chol Direct Kit-P.n. 4005, 4103,4123	Morax	JHO	Class I	2002-01-17
K012759	Inspectra Tissue Spectrometer System (Inspectra), Model 325	Hutchinson Technology, Inc.	MUD	Class II	2002-01-17
K012580	Erchonia Pl2000	Tuco Innovations, Inc.	NHN	Class II	2002-01-17
K012139	Vamos Anesthetic Gas Monitor	Draeger, Inc.	CCK	Class II	2002-01-17
K012037	Healthlife Oxygen Concentrator Model As009	Airsep Corp.	CAW	Class II	2002-01-17
K012012	ECG Home	H&C Medical Devices SpA	DXH	Class II	2002-01-17
K011839	Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C	Doxa Certex AB	EBF	Class II	2002-01-17
K011771	Randox Theophylline	Randox Laboratories, Limited	KLS	Class II	2002-01-17
K011355	Biolight Pcd	Biolight International AB	ILY	Class II	2002-01-17
K014206	Logiqbook	General Electric Co.	IYO	Class II	2002-01-16
K014137	Modification to Ebi Omega 21 System	Ebi, LLC	MNH	Class II	2002-01-16
K014124	Numed Coefficient Ptv Catheters	Numed Inc	OMZ	Class II	2002-01-16
K014122	Hl168e	Health & Life Corporation	DXN	Class II	2002-01-16