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 363 of 3528

510(k) clearances, page 363 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202988	Tixel System	Novoxel Inc.	GEI	Class II	2021-02-25
K202514	EchoS Family	Echolight S.p.A.	MUA	Class II	2021-02-25
K202420	Infrared Forehead Thermometer	Conmo Electronic Company Limited	FLL	Class II	2021-02-25
K202240	Disposable Surgical Mask/Fluid Resistant Procedure Mask	Lhm Medical Technology (Hong Kong) Limited	FXX	Class II	2021-02-25
K201971	SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2021-02-25
K201969	SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System	CHISON Medical Technologies Co., Ltd.	IYN	Class II	2021-02-25
K201945	KARL STORZ UDEL Sterilization Trays	Karl Storz Endoscopy-America, Inc.	KCT	Class II	2021-02-25
K201436	Vortek Single Loop Ureteral Stent	MEDLINE INDUSTRIES, LP - Northfield	FAD	Class II	2021-02-25
K201142	TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set	Simplivia Healthcare Ltd.	ONB	Class II	2021-02-25
K210239	CITRESPLINE and CITRELOCK ACL Implants	Acuitive Technologies	MAI	Class II	2021-02-24
K210202	BioWaveGO RX	Biowave Corporation	GZJ	Class II	2021-02-24
K210195	Triever Catheters	Inari Medical, Inc.	QEW	Class II	2021-02-24
K203479	ExtremiLOCK Lateral Ankle Fusion Plates	Osteomed	HRS	Class II	2021-02-24
K203255	4K UHD Laparoscope	Scivita Medical Technology Co., Ltd.	GCJ	Class II	2021-02-24
K202184	Practical Navigation Surgical Guidance System (PNSGS)	Practical Navigation, LLC	OLO	Class II	2021-02-24
K202003	Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim	GMP Medicare Sdn Bhd	LZA	Class I	2021-02-24
K201906	Trinity ELE Plus and Trinity ELE Plus Pro	Carol Cole Company dba NuFACE	NFO	Class II	2021-02-24
K201703	PROXEO Twist Cordless Polishing System PL-40 H	W & H DentalWerk Buermoos GmbH	EKX	Class I	2021-02-24
K200734	Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit	Sirius Medical Systems B.V.	PBY	Class II	2021-02-24
K210269	PowerDot PD-01MT2 Muscle Stimulator	Smartmissimo Technologies Pte, Ltd.	IPF	Class II	2021-02-23
K210190	ClotTriever Thrombectomy System	Irani Medical, Inc.	QEW	Class II	2021-02-23
K203804	Global Med Systems Milesman Compact Laser	Global Med Systems SL	GEX	Class II	2021-02-23
K203784	PreXion3D Explorer PRO	Prexion Corporation	OAS	Class II	2021-02-23
K203494	Nissha Medical Technologies Neutral Electrodes	Nissha Medical Technologies Limited	GEI	Class II	2021-02-23
K203406	Lumify Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2021-02-23
K202950	StitchKit COMBO	ORIGAMI SURGICAL Inc.	GAM	Class II	2021-02-23
K202789	Monaco Rtp System	Elekta Solutions AB	MUJ	Class II	2021-02-23
K202339	Molekule Air Mini, Molekule Air Mini +	Molekule, Inc.	FRA	Class II	2021-02-23
K202048	Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App	Cochlear Americas	LXB	Class II	2021-02-23
K201915	GenesisZr 4Y+ (ST1100) Zirconia	United Dental Resources Corporation	EIH	Class II	2021-02-23
K201743	ClarifEye R1.0, ClarifEye Needle	Philips Medical Systems Nederland B.V.	OWB	Class II	2021-02-23
K201501	Veolity	Mevis Medical Solutions AG	OEB	Class II	2021-02-23
K200439	Velano ExT Extension Set	Becton Dickinson Infusion Therapy Systems Inc.	FPA	Class II	2021-02-23
DEN200028	Lumenis Stellar M22	Lumenis Ltd	QIU	Class II	2021-02-23
K210240	Air Compression Therapy Device, model HW6007	Konliking Tech & Dev. Limited	IRP	Class II	2021-02-22
K203522	Surn5 Electrosurgical Argon Beam Generator and Accessories	Surnic Corporation	GEI	Class II	2021-02-22
K203493	MectaLock Extension	Medacta International SA	MAI	Class II	2021-02-22
K202662	Parcus Titanium Interference Screws	Parcus Medical, L.L.C.	MBI	Class II	2021-02-22
K201868	Phyziofit Medical Surgical Mask	Wellpower Sporting Goods Co., Ltd.	FXX	Class II	2021-02-22
K201652	COBRA-OS Kit	Front Line Medical Technologies Inc.	MJN	Class II	2021-02-22
K200062	Foot and Ankle System	Leith Medical LLC	HRS	Class II	2021-02-22
K202112	Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece	Storz Medical AG	PZL	Class II	2021-02-21
K210192	A.L.P.S. Clavicle Plating System	Zimmer GmbH	HRS	Class II	2021-02-19
K210167	DELTA XTEND Reverse Shoulder System	Depuy Orthopaedics Inc.	PHX	Class II	2021-02-19
K210155	Duo Expandable Interbody Fusion System	Spineology, Inc.	MAX	Class II	2021-02-19
K203754	Eustachi Ear Pressure Relief Device	Exercore, LLC	MJV	Unclassified	2021-02-19
K203488	emField	Zimmer Medizinsysteme GmbH	IPF	Class II	2021-02-19
K203462	Advanced Dental Appliance	Dasoft Partners	LRK	Class II	2021-02-19
K203442	Inbrace Orthodontic System	Swift Health Systems, Inc.	PNN	Class II	2021-02-19
K202995	X-ray Flat Panel Detectors/CareView 3600RF	Careray Digital Medical System Co., Ltd.	MQB	Class II	2021-02-19