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 368 of 3528

510(k) clearances, page 368 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202742	Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory	Viasonix Ltd.	IYN	Class II	2021-01-25
K201468	Pulse Oximeter	Shenzhen Creative Industry Co., Ltd	DQA	Class II	2021-01-25
K202336	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2021-01-23
K201187	Cytoplast Titanium-Reinforced PTFE Membranes	Osteogenics Biomedical, Inc.	NPK	Class II	2021-01-23
K203656	Non-Contact Forehead Thermometer (UT30H)	Uni-Trend Technology (China) Co., Ltd.	FLL	Class II	2021-01-22
K203373	Advanced Research Medical Trident SI Screw System	Advanced Research Medical	OUR	Class II	2021-01-22
K203181	Nerivio, FGD000075-4.7	Theranica Bio-Electronics Ltd.	QGT	Class II	2021-01-22
K203131	EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform	Edwards Lifesciences LLC	DXN	Class II	2021-01-22
K203010	Platinum dRF Imaging System	Apelem-Dms Group	JAA	Class II	2021-01-22
K202858	Flex-ThreadTM Distal Fibula Intramedullary Nail System	Conventus Orthopaedics, Inc.	HSB	Class II	2021-01-22
K202792	BRIUS Clear Aligners	BRIUS Technologies Inc.	NXC	Class II	2021-01-22
K202660	SPRINT PNS System	SPR Therapeutics, Inc	NHI	Class II	2021-01-22
K202640	Surgical Mask	Jiangsu Medpure Biological Technology Co., Ltd.	FXX	Class II	2021-01-22
K202575	ClearPoint Array System	ClearPoint Neuro Inc.	HAW	Class II	2021-01-22
K202415	VirtueRF	ShenB Co., Ltd.	GEI	Class II	2021-01-22
K201782	NuFace Trinity Plus Device	Carol Cole Company dba NuFACE	NFO	Class II	2021-01-22
K201696	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length	Ethicon Endo-Surgery Inc	GEI	Class II	2021-01-22
K201553	Simply Iconic Implants	Implant Direct Sybron Manufacturing LLC	DZE	Class II	2021-01-22
K201066	ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length	Ethicon Endo-Surgery Inc	GEI	Class II	2021-01-22
K200037	Piccolo Medical SmartPICC System	Piccolo Medical	LJS	Class II	2021-01-22
K193266	Miin	Medico USA, Inc.	GEX	Class II	2021-01-22
K203189	Aerocure-Md	Aerobiotix, Inc.	FRA	Class II	2021-01-21
K202904	Surgical Face Mask	Jiangxi Feilikang Medical Technology Co., Ltd.	FXX	Class II	2021-01-21
K202839	Overlapped Compression Therapy	JKH Health Co., Ltd.	JOW	Class II	2021-01-21
K202672	Precision Delivery Infusion Set	Quest Medical, Inc	FPA	Class II	2021-01-21
K202595	Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask	Premier Guard USA, LLC	FXX	Class II	2021-01-21
K202507	EEA Circular Stapler with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2021-01-21
K202408	cobas CTNG for use on cobas 6800/8800 systems	Roche Molecular Systems Inc	QEP	Class II	2021-01-21
K202391	Dir 800	Aesculap Inc	IZI	Class II	2021-01-21
K201758	EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190	Olympus Medical Systems Corp.	EOQ	Class II	2021-01-21
K201366	Forwarts	Pronova Laboratories BV	GEH	Class II	2021-01-21
K200731	pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5	pjur group Luxembourg S.A.	NUC	Class II	2021-01-21
K202629	Dentsply Sirona Universal Spray Glazes	Dentsply Sirona Inc	EIH	Class II	2021-01-20
K203726	ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2021-01-19
K203719	IntraSight Mobile	Volcano Corporation	IYO	Class II	2021-01-19
K203485	SnugFit All-Suture Anchor	Medacta International SA	MBI	Class II	2021-01-19
K203153	CREO Stabilization System, Navigation Instruments, ExcelsiusGPS	Globus Medical, Inc.	NKB	Class II	2021-01-19
K202833	Sequel External Fixation Device	Sequel Medical Inc.	KTT	Class II	2021-01-19
K202363	HBP7 Settable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2021-01-19
K201685	Potenza	Jeisys Medical Inc.	GEI	Class II	2021-01-19
K201219	Biocore9 Femoral Head Resurfacing Component	BIOCORE9 LLC	KXA	Class II	2021-01-19
K200163	Ava Fertility Tracker	Ava AG	LHD	Unclassified	2021-01-19
K192913	R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose	Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S.	KLE	Class II	2021-01-19
K201930	Nanum Syringe	Nanum Company Co., Ltd.	FMF	Class II	2021-01-17
K200565	Galapogos	ResMed Corp	BZD	Class II	2021-01-17
K203683	CarboClear Lumbar Cage System	Carbofix Orthpedics, Ltd.	MAX	Class II	2021-01-15
K203678	CD HORIZON™ Spinal System	Medtronic Sofamor Danek USA Inc	NQP	Class II	2021-01-15
K203677	ViewPoint 6	GE Healthcare	LLZ	Class II	2021-01-15
K203506	PERLA® TL posterior osteosynthesis system	Spineart SA	NKB	Class II	2021-01-15
K203381	Dynanail Mini Hybrid	Medshape, Inc.	HWC	Class II	2021-01-15