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 424 of 3528

510(k) clearances, page 424 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192273	DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit	Diadent Group International	KLE	Class II	2020-02-07
K191975	Elefix V Paste for EEG & EMG	Nihon Kohden Corp.	GYB	Class II	2020-02-07
K191416	Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack	Caldera Medical, Inc.	PAH	Class II	2020-02-07
K191347	Paragon XHD Diagnostic Ultrasound System	Shenzhen Wisonic Medical Technology Co., Ltd.	IYN	Class II	2020-02-07
K191298	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Medical	JFL	Class II	2020-02-07
K190259	Vesta RF Cannula	Biomerics	GXI	Class II	2020-02-07
K183688	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Medical	JGS	Class II	2020-02-07
K183678	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Medical	CGA	Class II	2020-02-07
K182927	Pulmonary Cytology Brush	Hobbs Medical, Inc.	BTG	Class II	2020-02-07
DEN190040	Caption Guidance	Bay Labs, Inc.	QJU	Class II	2020-02-07
K193610	BreathID Smart System	Meridian Bioscience Israel Ltd.	MSQ	Class I	2020-02-06
K193521	Steerable Plateau Ti	Life Spine	MAX	Class II	2020-02-06
K193461	MectaLock All-Suture Anchors	Medacta International SA	MBI	Class II	2020-02-06
K192757	VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20	VitalConnect, Inc.	DRG	Class II	2020-02-06
K192002	Lucy Point-of-Care Magnetic Resonance Imaging Device	Hyperfine Research, Inc.	LNH	Class II	2020-02-06
K191890	Elos Accurate Customized Abutment	Elos MedTech Pinol a/S	NHA	Class II	2020-02-06
K191571	UV Radiation Treatment System	Xuzhou Yongkang Electronic Science Technology Co., Ltd	FTC	Class II	2020-02-06
K191529	da Vinci Xi Surgical System, da Vinci X Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2020-02-06
K191411	Ah!Yes Ob Coco Personal Lubricant	Bio-Tech Lubricants Ltd	NUC	Class II	2020-02-06
K191290	Ancora Nerve Block Catheter Set	Ancora Medical Technology	BSP	Class II	2020-02-06
K190800	Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors	Cosmed S.r.l.	BTY	Class II	2020-02-06
K200170	SpineNet SSP System	SpineNet LLC	KWQ	Class II	2020-02-05
K200038	Endosee System	CooperSurgical, Inc.	HIH	Class II	2020-02-05
K193396	PERLA® TL posterior osteosynthesis system	Spineart SA	NKB	Class II	2020-02-05
K192806	DENTCA Crown and Bridge	Dentca, Inc.	EBG	Class II	2020-02-05
K192785	OptiScanner® 5000 Glucose Monitoring System	Optiscan Biomedical Corp.	LZF	Class II	2020-02-05
K192127	Respire Pink AT (Hard, Hard/Soft, EF)	Respire Medical Holdings	LRK	Class II	2020-02-05
K180935	Infinity / Infinity Cross Flex Dental Systems	Olsen Industria e Comercio S/a	EIA	Class I	2020-02-05
K200050	Akesis Galaxy RTx	Akesis Inc.	IWB	Class II	2020-02-04
K193398	Summit DuoFix HA Coating	Depuy Orthopaedics Inc.	MEH	Class II	2020-02-04
K193324	Motion Correction System	Kineticor, Inc.	LNH	Class II	2020-02-04
K193320	KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System	Kyocera Medical Technologies, Inc.	OVD	Class II	2020-02-04
K192688	s-Clean SQ-SL Implant System Regular	Dentis Co.,Ltd	DZE	Class II	2020-02-04
K191832	Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)	Kurin, Inc.	JKA	Class II	2020-02-04
K191532	The Caterpillar and Caterpillar Micro Arterial Embolization Devices	C.R. Bard Inc	KRD	Class II	2020-02-04
K183148	OKLand Patient Return Electrode Pad	Auckland Medical Polymer (Tianjin) Co., Ltd	GEI	Class II	2020-02-04
K192579	X-Guide Surgical Navigation System	X-NAV Technologies, LLC	PLV	Class II	2020-02-03
K190966	Katalyst Training System	Katalyst, Inc.	NGX	Class II	2020-02-03
K190962	Bella-mu	U-Needle B.V.	FMI	Class II	2020-02-03
K190842	Comus Locking Plate systems	Jiangsu Trauhui Medical Instrument Co., Ltd.	HRS	Class II	2020-02-03
K193128	Mako Total Hip Application	Mako Surgical Corp.	OLO	Class II	2020-02-02
K200030	Optima Coil System	Balt USA, LLC	HCG	Class II	2020-02-01
K200018	Had1717mc	H&abyz	MQB	Class II	2020-01-31
K193480	BIOEASY Multi-Drug Test Cup	Shenzhen Bioeasy Biotechnology Co., Ltd.	NGL	Class II	2020-01-31
K193284	Physica LMC Knee System	Lima Corporate S.p.A.	JWH	Class II	2020-01-31
K193270	CapLOX II®/TowerLOX® MIS Pedicle Screw System	CAPTIVA SPINE, Inc.	NKB	Class II	2020-01-31
K193258	ProLift Expandable System	Life Spine	MAX	Class II	2020-01-31
K193257	ACUSON Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2020-01-31
K193192	Tamper Evident Cap	Intl. Medical Industries	FMF	Class II	2020-01-31
K192535	Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia	Qinhuangdao Audental Metal Technology Co., Ltd.	EIH	Class II	2020-01-31