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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 707 of 3530

510(k) clearances, page 707 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K150184	Dymaxeon Spine System	Back 2 Basics Direct, LLC	NKB	Class II	2015-06-15
K143090	Luminesse Pre-Sintered Zirconia Coloring Liquid	Talladium Inc	EIH	Class II	2015-06-15
K142751	Chang Gung ComMed Series Dental Implant System	Chang Gung Medical Technology Co., Ltd.	DZE	Class II	2015-06-15
K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2015-06-15
K151238	JUSHA-M23C LCD Monitor	Nanjing Jusha Display Technology Co., Ltd	PGY	Class II	2015-06-12
K150718	Wi-3 HAL-RAR System	Agency for Medical Innovations Inc.	FHN	Class II	2015-06-12
K150616	Trevo XP ProVue Retriever (4x30mm)	Concentric Medical, Inc.	NRY	Class II	2015-06-12
K150582	Vertaplex® High Viscosity (HV) Radiopaque Bone Cement	Stryker Corp.	NDN	Class II	2015-06-12
K150496	Total Knee Arthroplasty System	Responsive Orthopedics, LLC	JWH	Class II	2015-06-12
K150415	NilRead	Perceptive Software	LLZ	Class II	2015-06-12
K150414	Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL	Industrial Clothings (Pvt), Ltd.	LZA	Class I	2015-06-12
K150378	NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook	Nico Corporation	GZT	Class II	2015-06-12
K150376	Sonoma Cancellous Bone Screw and Washer	Sonoma Orthopedics Products, Inc.	HWC	Class II	2015-06-12
K150319	Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/xsft Stretch Resistant Microcoil Delivery Systems	Cerenovus, Inc.	HCG	Class II	2015-06-12
K150080	Dc-8/Dc-8 Pro/dc-8 Cv/dc-8 Exp/dc-8S	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2015-06-12
K142835	Iliad Pedicle Screw System and Zenius Pedicle Screw System	Medyssey USA	NKB	Class II	2015-06-12
K142783	HEARTWAY Electrically Powered Wheelchair P27	Heartway Medical Products Co., Ltd.	ITI	Class II	2015-06-12
K142679	Carescape R860	GE Healthcare	CBK	Class II	2015-06-12
K142626	Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters	Medela AG	OMP	Class II	2015-06-12
K142598	Opto Wire and OptoMonitor System	Opsens Inc.	DQX	Class II	2015-06-12
K142416	Luma Wrap	Salter Labs	PDH	Class II	2015-06-12
K141943	Breathe Technologies Life2000 Ventilation System	Breathe Technologies, Inc.	CBK	Class II	2015-06-12
K151244	Pre-Formed Guidewire	Lake Region Medical	DQX	Class II	2015-06-11
K150548	Tek RMD (Tek Robotic Mobilization Device)	Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San ve Tic.A.S	IPL	Class II	2015-06-11
K150489	EOS PMP, EOS PMP Integrated	Corcym Inc.	DTZ	Class II	2015-06-11
K150373	Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]	Grandway Technology (Shenzhen) Limited	DXN	Class II	2015-06-11
K150362	NuVasive CoRoent Small Interbody System	Nu Vasive, Incorporated	ODP	Class II	2015-06-11
K150280	PulmoVia Working Channel	Sanovas, Inc.	EOQ	Class II	2015-06-11
K150250	SternSnap Angled Attachment	Sterngold Dental LLC	NHA	Class II	2015-06-11
K150216	Synergy Cranial	Medtronic Navigation, Inc	HAW	Class II	2015-06-11
K150135	DIVERGENCE-L Anterior/Oblique Lumbar Fusion System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2015-06-11
K143559	Xp1000 RF	BTL Industries, Inc	GEI	Class II	2015-06-11
K142645	Avenue T TLIF Cage	Ldr Spine USA	OVD	Class II	2015-06-11
K142577	PANTHER Endo Linear Cutter Staplers with Single Use Loading Units	B.j.zh.f.panther Medical Equipment Co.,Ltd	GDW	Class II	2015-06-11
K142512	Personalized Physiology Analytics Engine software	Vgbio, Inc (dba Physiq)	PLB	Class II	2015-06-11
K141332	Captiva Spine SmartLOX Cervical Plate System	CAPTIVA SPINE, Inc.	KWQ	Class II	2015-06-11
K151291	BD Veritor (TM) System for the Rapid Detection of Flu A+B	Becton Dickinson & Co	PSZ	Class II	2015-06-10
K151260	ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD	Cardiovascular System, Inc.	MCW	Class II	2015-06-10
K151253	2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter	Boston Scientific Corporation	PNO	Class II	2015-06-10
K150867	Affixus Tibial Nailing System	Zimmer GmbH	HSB	Class II	2015-06-10
K150569	LaparoVue	Buffalo Filter Co., Inc.	GCJ	Class II	2015-06-10
K143730	GBR System	Jeil Medical Corporation	JEY	Class II	2015-06-10
K143572	Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK	Osteomed Implantes, Ltda	ODP	Class II	2015-06-10
K142920	KM Needles (Acupuncture Needle)	K.M.S., Inc.	MQX	Class II	2015-06-10
K151240	extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc	Devon Medical Products	OMP	Class II	2015-06-09
K150753	OASYS System	Stryker Corp.	KWP	Class II	2015-06-09
K150662	Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)	Ypsomed AG	FMI	Class II	2015-06-09
K150625	Morrison Steerable Needle	AprioMed AB	KNW	Class II	2015-06-09
K150593	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)	Hartalega Sdn Bhd	LZA	Class I	2015-06-09
K150578	Capillus 272 Office Pro	Capillus, LLC	OAP	Class II	2015-06-09