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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 548 of 3529

510(k) clearances, page 548 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173602	Optima XR240amx, AutoGrid	GE Healthcare	IZL	Class II	2018-01-12
K173588	Illumeo System	Philips Medical Systems Technologies Ltd.	LLZ	Class II	2018-01-12
K173560	Microcatheter	Surmodics, Inc.	DQY	Class II	2018-01-12
K173547	ImagenUniversal	Cardiovascular Imaging Technologies, LLC	KPS	Class II	2018-01-12
K173504	K-Y Silicone	Reckitt Benckiser LLC	NUC	Class II	2018-01-12
K173291	6440 Ultrasound System	Esaote S.p.A.	IYN	Class II	2018-01-12
K172913	cobas Factor II and Factor V Test	Roche Molecular Systems Inc	NPR	Class II	2018-01-12
K172774	T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System	Stryker Trauma GmbH	HSB	Class II	2018-01-12
K172548	Wiltrom Spinal Fixation System	Wiltrom Corporation Limited	NKB	Class II	2018-01-12
K172438	ARBOR External Fixation System	Globus Medical, Inc.	KTT	Class II	2018-01-12
K172287	ipsogen JAK2 RGQ PCR Kit	Qiagen	PSU	Class II	2018-01-12
K171958	Piezosurgery Touch, Piezosurgery White	Mectron S.p.A.	DZI	Class II	2018-01-12
K171628	HBS2 Headless Bone Screw	Stuckenbrock Medizintechnik GmbH	HWC	Class II	2018-01-12
K171625	Single Lumen Ovum Aspiration Needles	Willian A. Cook Australia Pty, Ltd.	MQE	Class II	2018-01-12
K171498	MSD CRP Assay Kit and MESO SECTOR S 700 Instrument	Meso Scale Diagnostics, LLC	DCN	Class II	2018-01-12
K171411	IRRIS (Infra-Red-Red Intubation System)	A.R Guide in Medical, Ltd.	BTR	Class II	2018-01-12
K171311	A5 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BSZ	Class II	2018-01-12
K171292	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BSZ	Class II	2018-01-12
K171213	One Touch Condom with Benzocaine	Thai Nippon Rubber Industry Public Company Limited	HIS	Class II	2018-01-12
K171148	Aleo BME Liquid Bandage	Aleo Bme, Inc.	KMF	Class I	2018-01-12
K163451	Action Trackstander models TR1816, TR1820, TR2016, and TR2020	Action Manufacturing, Inc.	IPL	Class II	2018-01-12
K173090	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4	Toshibamedical Systems Corporation	IYN	Class II	2018-01-11
K172992	Diazyme EZ Vitamin D Assay	Diazyme Laboratories, Inc.	MRG	Class II	2018-01-11
K172804	Besmed Peak Flow Meter	Besmed Health Business Corporation	BZH	Class II	2018-01-11
K172655	Automated ankle brachial pressure index measuring device	Mesi d.o.o.; Mesi, Development of Medical Devices, Ltd.	JOM	Class II	2018-01-11
K172452	Bruxor	Sleep Specialties, LLC	OBR	Unclassified	2018-01-11
K172224	DTX Studio diagnose	Nobel Biocare AB	LLZ	Class II	2018-01-11
K172205	ExoToe Staple	Exotoe LLC	JDR	Class II	2018-01-11
K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Sebia, Inc.	CFF	Class II	2018-01-11
K172110	ECHELON OVAL V6.0A MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2018-01-11
K171665	Microcatheter and guide-wire system	Suzhou Hengrui Disheng Medical Co., Ltd.	KRA	Class II	2018-01-11
K171622	Dentium Ti-Base	Dentium Co., Ltd.	NHA	Class II	2018-01-11
K171517	Digital Electrocardiograph	Biocare Bio-Medical Equipment Co., Ltd.	DPS	Class II	2018-01-11
K171207	FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M	FUJIFILM Healthcare Americas Corporation	ODG	Class II	2018-01-11
K171122	CEREC Ortho Software	Dentsply Sirona Inc	PNN	Class II	2018-01-11
K170748	GLOBAL UNITE Platform Shoulder System	Depuy Ireland UC	PHX	Class II	2018-01-11
K170421	ET Hybrid Abutment	Hiossen, Inc.	NHA	Class II	2018-01-11
K173768	Tempus Pro Patient Monitor	Remote Diagnostic Technologies Ltd.	MHX	Class II	2018-01-10
K173563	Arc Adjustable Radial Cuff Compression Device	TZ Medical Inc.	DXC	Class II	2018-01-10
K173234	Swiss LithoClast Trilogy	E.M.S. - Electro Medical Systems SA	FEO	Class II	2018-01-10
K173170	Epicardia Anywhere	Medicomp, Inc.	DSI	Class II	2018-01-10
K172929	Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath	Boston Scientific Corporation	LJE	Unclassified	2018-01-10
K172358	Instalief	Privi Medical Pte, Ltd.	LKX	Unclassified	2018-01-10
K172336	Smith & Nephew Patient Matched Cutting Blocks	Smith & Nephew, Inc.	JWH	Class II	2018-01-10
K172051	Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter	Cook Incorporated	MQF	Class II	2018-01-10
K171833	Digital Blood Pressure Monitor-Wrist Style	Shenzhen Combei Technology Co.,Ltd.	DXN	Class II	2018-01-10
K171722	Electrodes with snap / Electrodes with pigtail	Shenzhen Konmed Technology Co., Ltd	GXY	Class II	2018-01-10
K171445	Amplatz Support Wire Guide with Apex Curve	Cook Incorporated	DQX	Class II	2018-01-10
K171421	VERTICALE® Posterior Spinal Fixation System/VERTICALE® System	Silony Medical GmbH	NKB	Class II	2018-01-10
K173508	Everest Spinal System	K2M, Inc	NKB	Class II	2018-01-09