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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 616 of 3529

510(k) clearances, page 616 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160515	PS2 Knee System	Consensus Orthopedics, Inc.	JWH	Class II	2016-12-19
K160007	Paclitaxel Sets	Baxter Healthcare Corporation	FPA	Class II	2016-12-19
DEN160005	Hem-Avert Perianal Stabilizer	Stetrix Inc.	PNU	Class II	2016-12-19
DEN150057	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	Roche Diagnostics GmbH	PQO	Class II	2016-12-19
K160707	CustomizedBone Service	Fin-Ceramica Faenza SpA	GXN	Class II	2016-12-17
K163236	COOLIEF Cooled Radiofrequency Kit	Halyard Health	GXI	Class II	2016-12-16
K163213	Revolution CT	GE Healthcare	JAK	Class II	2016-12-16
K162638	CETRA Anterior Cervical Plate System	Orthofix SRL	KWQ	Class II	2016-12-16
K162578	Zerona Z6 OTC	Erchonia Corporation	OLI	Class II	2016-12-16
K162373	LC Bead LUMI	BIOCOMPATIBLES U.K. Limited, a BTG Company	KRD	Class II	2016-12-16
K162302	Somatom Confidence ® RT Pro	Siemens Medical Solutions USA, Inc.	JAK	Class II	2016-12-16
K162161	Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit	Stimwave Technologies Incorporated	GZB	Class II	2016-12-16
K162020	VITROS Chemistry Products Cl- Slides	Ortho-Clinical Diagnostics, Inc.	CGZ	Class II	2016-12-16
K161947	Chagas Detect Plus Rapid Test	Inbios International, Inc.	MIU	Class I	2016-12-16
K161837	ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer	Siemens Healthcare Diagnostics Inc.	JGS	Class II	2016-12-16
K161713	Dentium CAD/CAM Abutments	Dentium Co., Ltd.	NHA	Class II	2016-12-16
K161237	HyperView Hyperspectral Tissue Oxygenation Measurement System	Hypermed Imaging, Inc.	MUD	Class II	2016-12-16
K160742	NoCoding1 Plus Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2016-12-16
K160614	Xcite Clinical Station	Restorative Therapies Inc.	IPF	Class II	2016-12-16
DEN150038	CleanCisionTM Wound Retraction and Protection System	Prescient Surgical	PQI	Class II	2016-12-16
K163347	xTAG Cystic Fibrosis 39 Kit v2	Luminex Molecular Diagnostics Inc	NUA	Class II	2016-12-15
K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	Luminex Molecular Diagnostics Inc	NUA	Class II	2016-12-15
K163335	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	Eizo Corporation	PGY	Class II	2016-12-15
K163206	SMD-Sr90-DA Radionuclide Brachytherapy Source	Salutaris Medical Devices, Inc.	KXK	Class II	2016-12-15
K162902	ARIETTA Prologue Diagnostic Ultrasound system and Transducers	Hitachi, Ltd.	IYN	Class II	2016-12-15
K162845	DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2016-12-15
K162568	Intrabeam 600	Carl Zeiss Meditec Inc	JAD	Class II	2016-12-15
K162371	Pulsaderm ACE-All Blue	Nutra Luxe MD, LLC	OLP	Class II	2016-12-15
K162247	Permatape	Medos International SARL	GAT	Class II	2016-12-15
K162192	BluePro	Bluesom	LRK	Class II	2016-12-15
K161060	Arthrex iBalance UKA System Vitamin E Tibial Bearing	Arthrex GmbH	HSX	Class II	2016-12-15
K160852	Zia	Zetta Medical Technologies, LLC	LLZ	Class II	2016-12-15
K160849	WS(TM) Far-Infrared Therapy Unit, Model KP-B210	Ws Far IR Medical Technology Co., Ltd.	ILY	Class II	2016-12-15
K160836	Menai System	ResMed Corp	BZD	Class II	2016-12-15
K160798	IPS e.max® Press Abutment Solutions for Viteo Base Ti	Ivoclar Vivadent, Inc.	NHA	Class II	2016-12-15
K143369	MRidium 3860+ MRI infusion Pump/ Monitoring System	Iradimed Corporation	FRN	Class II	2016-12-15
K163200	Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete	Boston Scientific Corporation	LOX	Class II	2016-12-14
K163174	Emerge PTCA Dilatation Catheter	Boston Scientific Corporation	LOX	Class II	2016-12-14
K163163	XLTEK EMU40EX EEG Headbox	Natus Medical Incorporated	GWQ	Class II	2016-12-14
K162900	PowerMidline Catheter	C.R. Bard Inc	PND	Class II	2016-12-14
K162680	SOVEREIGN® Spinal System	Medtronic Sofamor Danek USA Inc	OVD	Class II	2016-12-14
K162343	Westmed Gas Sampling Cannula with O2 delivery	Westmed Inc	CCK	Class II	2016-12-14
K162134	ENNOVATE Spinal System	Aesculap Inc	NKB	Class II	2016-12-14
K162051	Cryotec	Reprolife Inc.	MQK	Class II	2016-12-14
K161755	Integrity-SI TM Fusion System	Coorstek Medical	OUR	Class II	2016-12-14
K161233	OXINIUM DH Fermoral Heads	Smith & Nephew, Inc.	MBL	Class II	2016-12-14
K160915	Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker	Roche Diagnostics GmbH	OVK	Class II	2016-12-14
K160475	Ritter Dental Implant System	Ritter Implants GmbH & Co. KG	DZE	Class II	2016-12-14
K160415	GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)	Instrumentation Laboratory Co.	GKF	Class II	2016-12-14
K160412	GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)	Instrumentation Laboratory Co.	CHL	Class II	2016-12-14