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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 433 of 3528

510(k) clearances, page 433 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K182987	Genesys Spine 3DP Lumbar Interbody System	Genesys Spine	MAX	Class II	2019-12-12
DEN180056	GSP Neonatal Creatine Kinase - MM kit	Revvity Health Sciences, Inc.	QJE	Class II	2019-12-12
K193167	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	Luminex Molecular Diagnostics Inc	OCC	Class II	2019-12-11
K193135	TSolution One Total Knee Application	Think Surgical Inc.	OLO	Class II	2019-12-11
K193132	CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream	Hangzhou Clongene Biotech Co., Ltd.	LCX	Class II	2019-12-11
K193126	HI-TORQUE InfilTrac Guide Wire Family	Abbott Vascular	DQX	Class II	2019-12-11
K193123	FUJIFILM Distal Cap Models 33-40	FUJIFILM Corporation	FDS	Class II	2019-12-11
K192571	NemoScan	Software Nemotec, S.L.	LLZ	Class II	2019-12-11
K192507	LOSPA II Knee System	Corentec Co., Ltd.	JWH	Class II	2019-12-11
K192149	MIS Dental Implant System	Dentsply Sirona Inc	DZE	Class II	2019-12-11
K191880	Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter	Innovative Health, LLC.	DRF	Class II	2019-12-11
K191618	SleepTight Mouthpiece STZ	Michael D Williams Dds PA	LRK	Class II	2019-12-11
K191086	Exciplex	Clarteis	FTC	Class II	2019-12-11
K190508	EVO 450 series High Speed Handpieces	Ttbio Corporation	EFB	Class I	2019-12-11
K182739	Endotracheal Tube with Evacuation Lumen	Well Lead Medical Co. Ltd	BTR	Class II	2019-12-11
K192929	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900	STERIS Corporation	MED	Class II	2019-12-10
K192533	Health Line CT CVC	Health Line International Corporation	FOZ	Class II	2019-12-10
K192516	Diode Laser 808nm	Beijing Superlaser Technology Co., Ltd.	GEX	Class II	2019-12-10
K192319	HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-12-10
K192287	Transpara	Screenpoint Medical	QDQ	Class II	2019-12-10
K190239	Single Use Aspiration Needle	Olympus Medical Systems Corp.	KTI	Class II	2019-12-10
K192885	C.T.M. Mobility Scooter HS-268	Chien TI Enterprise Co., Ltd.	INI	Class II	2019-12-09
K192522	TSV BellaTek Express and BellaTek Flex Abutments	ZimVie US Corp LLC	NHA	Class II	2019-12-09
K192442	FFRangio	Cathworks Ltd.	QEK	Class II	2019-12-09
K192439	JETi Peripheral Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2019-12-09
K192225	Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses	Vizionfocus Inc.	LPL	Class II	2019-12-09
K191895	Straumann Mini Implants	Straumann USA, LLC	DZE	Class II	2019-12-09
K191793	Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System	Nebula Surgical Private Limited	HRS	Class II	2019-12-09
K191700	EyeStat	Blinktbi, Inc.	GZP	Class II	2019-12-09
K191054	Southern Implants MAX Implant System	Southern Implants, (Pty.) Ltd.	DZE	Class II	2019-12-09
K190968	CEDIA Benzodiazepine Assay	Microgenics Corporation	JXM	Class II	2019-12-09
K181900	Dental high speed handpiece, Dental low speed handpiece	Foshan CICADA Dental Instrument Co., Ltd.	EFB	Class I	2019-12-09
K190273	T3 Platform software	Etiometry Inc.	MWI	Class II	2019-12-08
K192279	PhantomMSK Trauma	Orthogrid Systems, Inc	LLZ	Class II	2019-12-07
K193030	Avenir Muller Stem, Avenir Cemented Hip Stem	Zimmer GmbH	LZO	Class II	2019-12-06
K192773	Allive	NU Eyne Co., Ltd.	PCC	Class II	2019-12-06
K192521	Intense Pulsed Light Treatment System	Shangdong Huamei Technology Co., Ltd.	ONF	Class II	2019-12-06
K192443	Dextile Anatomical Mesh	Sofradim Production	FTL	Class II	2019-12-06
K192324	Sheridan Spiral-Flex Endotracheal Tubes	Teleflexmedical, Inc.	BTR	Class II	2019-12-06
K191861	Aurora Surgiscope System	Rebound Therapeutics, Corporation	GWG	Class II	2019-12-06
K191279	Disposable SpO2 Sensor	Shenzhen Caremed Medical Technology Co.,Ltd.	DQA	Class II	2019-12-06
K191239	Smart Peak Flow Meter	Guangzhou Homesun Medical Technology Co., Ltd	BZH	Class II	2019-12-06
K190656	Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings	Zimmer GmbH	LPH	Class II	2019-12-06
K190612	EQUINOX Balloon Dilatation Catheter	Dornier Medtech America, Inc.	EZN	Class II	2019-12-06
K190552	JJ Implant System	Jj Implants	DZE	Class II	2019-12-06
K190382	Intraocular Pressure Tonometer EASYTON	Company Elamed	HKX	Class II	2019-12-06
K183052	ID-Cap System	Etectrx, Inc.	OZW	Class II	2019-12-06
K193028	MEDRAD Mark 7 Arterion Injection System	Medrad, Inc.	DXT	Class II	2019-12-05
K192766	Digital Intraoral Imaging Plate System	Fsusen Technology Co., Ltd.	MUH	Class II	2019-12-05
K192482	Elekta Unity	Elekta Limited	IYE	Class II	2019-12-05