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 571 of 3529

510(k) clearances, page 571 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163710	BePOD® EZ Weil Screws	Fournitures Hospitalieres Industrie	HWC	Class II	2017-09-08
K163699	ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook	Aln Implants Chirurgicaux	DTK	Class II	2017-09-08
K163465	hemochroma PLUS System	Immunostics, Inc.	GKR	Class II	2017-09-08
K163292	Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford	Spectra Medical Devices, LLC	BSP	Class II	2017-09-08
K172489	Reliance Cervical IBF System	Reliance Medical Systems, LLC	ODP	Class II	2017-09-07
K172433	NICO BrainPath	Nico Corporation	GZT	Class II	2017-09-07
K171730	FuckWater	Non-Friction Products Inc.	NUC	Class II	2017-09-07
K171126	Implantium II	Dentium Co., Ltd.	DZE	Class II	2017-09-07
K170981	NeuroQuant	Cortechs Labs, Inc.	LLZ	Class II	2017-09-07
K170855	T-Rex Standalone ALIF	Siats, LLC	OVD	Class II	2017-09-07
K170442	Cranial Drill Bits and Accessories	AD-Tech Medical Instrument Corp.	HBE	Class II	2017-09-07
K170381	Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini	Medtronic Navigation, Inc	GEI	Class II	2017-09-07
K170041	XableCath Support Catheter	Xablecath, Inc.	DQY	Class II	2017-09-07
K162171	S4 Screw System™	Subchondral Solutions	HWC	Class II	2017-09-07
K172394	Steerable Guide Catheter	Abbott Vascular	DRA	Class II	2017-09-06
K172375	MicroSTAAR Injector System Cartridges	Staar Surgical AG	MSS	Class I	2017-09-06
K172372	QuadraSphere Microspheres	Biosphere Medical, S.A.	KRD	Class II	2017-09-06
K171496	Tritanium C Anterior Cervical Cage	Howmedica Osteonics Corp	ODP	Class II	2017-09-06
K171178	Central Monitoring System	Edan Instruments, Inc.	HGM	Class II	2017-09-06
K171035	Katalyst Mark 1 Muscle Stimulation System	Katalyst, Inc.	NGX	Class II	2017-09-06
K171027	Dentis Dental Implant System	Dentis Co.,Ltd	DZE	Class II	2017-09-06
K163538	QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls	Inova Diagnostics, Inc.	NBS	Class II	2017-09-06
K163510	Poseidon Ultrasound System	Butterfly Network, Inc.	IYN	Class II	2017-09-06
K161586	The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)	Shenzhen Homed Medical Device Co Ltd	CAF	Class II	2017-09-06
K172048	FluidSmart	Thermedx LLC	HIG	Class II	2017-09-05
K171687	Relieva SpinPlus Nav Balloon Sinuplasty System	Acclarent Inc	LRC	Class I	2017-09-05
K163525	QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls	Inova Diagnostics, Inc.	DBM	Class II	2017-09-05
K163464	Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)	BMC Medical Co., Ltd.	BZD	Class II	2017-09-05
K171583	RhythmView Workstation	Abbott Electrophysiology	DQK	Class II	2017-09-01
K171558	ExsoMed ITN Cannulated Screw System	Exsomed Holdings Company, LLC	HWC	Class II	2017-09-01
K171507	CustomizedBone Service	Fin-Ceramica Faenza SpA	GXN	Class II	2017-09-01
K171358	Emprint SX Ablation Platform and Accessories	Coviden, LLC	NEY	Class II	2017-09-01
K171323	Biophotas Celluma3	Biophotas, Inc.	OHS	Class II	2017-09-01
K171117	Carefusion NeutraClear Needle-free connector (EL-NC1000)	Cair LGL	FPA	Class II	2017-09-01
K170970	Epilaser	Epilady 2000, LLC	GEX	Class II	2017-09-01
K170547	Arthrex Mesh Plate System	Arthrex GmbH	HRS	Class II	2017-09-01
K170210	PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0	Given Imaging Ltd.	NEZ	Class II	2017-09-01
K170181	Prizma	G-Medical Innovations, Ltd.	DXH	Class II	2017-09-01
K163448	GrindCare System	Sunstar Suisse S.A.	HCC	Class II	2017-09-01
K163439	NaviENT	ClaroNav Inc.	HAW	Class II	2017-09-01
K163338	OMNIBotics Knee System	Omnllife Science, Inc.	OLO	Class II	2017-09-01
K163302	Senographe Pristina	GE Healthcare	MUE	Class II	2017-09-01
K172106	SHOFU MZ Primer Plus	Shofu Dental Corp.	KLE	Class II	2017-08-31
K172098	Medical Video Endoscope System	Zhuhai Pusen Medical Technology Co., Ltd.	FGB	Class II	2017-08-31
K172055	DUS-7000 Digital Color Doppler Ultrasound System	Advanced Instrumentations, Inc.	IYN	Class II	2017-08-31
K172033	Pirouette High Pressure (HP)	Arravasc Limited	LIT	Class II	2017-08-31
K171791	MAGEC® System	Nuvasive Specialized Orthopedics, Incorporated	PGN	Class II	2017-08-31
K171704	CAPRI Corpectomy Cage System	K2M, Inc	MQP	Class II	2017-08-31
K171642	Atellica IM Ferritin Assay	Siemens Healthcare Diagnostics Inc.	DBF	Class II	2017-08-31
K171570	Additional VIPER PRIME™ screws with fenestrations	Medos International SARL	NKB	Class II	2017-08-31