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 367 of 3528

510(k) clearances, page 367 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K203393	Fast-Fix Flex	Smith & Nephew, Inc.	GAT	Class II	2021-02-01
K203531	XYPAN Expandable Lumbar Cage System	Aegis Spine, Inc.	MAX	Class II	2021-01-29
K203220	cobas BKV	Roche Molecular Systems Inc	QLX	Class II	2021-01-29
K202970	Ventway Sparrow	Inovytech Medical Solutions, Ltd.	CBK	Class II	2021-01-29
K202878	Prase-AP Anterior Cervical Plate System	Gbs Commonwealth Co., Ltd.	KWQ	Class II	2021-01-29
K202398	Ti3Z Cervical Interbody System	Zavation Medical Products, LLC	ODP	Class II	2021-01-29
K202366	MAGIC Infusion Catheter	Balt USA, LLC	KRA	Class II	2021-01-29
K202358	Protective Face Mask for Medical Use	Hunan Heng Chang Pharmaceutical Co., Ltd.	FXX	Class II	2021-01-29
K202310	Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back	Wildcat Ppe, LLC	FYC	Class II	2021-01-29
K202282	Neodent Implant System - Zirconia Implant System	JJGC Industria e Comercio de Materiais Dentarios SA	NHA	Class II	2021-01-29
K202221	Vx650	Luneau Technology Operations	HKI	Class II	2021-01-29
K201993	E-connect S Endo Motor with built-in Apex Locator	Changzhou Sifary Medical Technology Co., Ltd.	EKX	Class I	2021-01-29
K201838	PediFlex Flexible Nail System	Orthopediatrics Corp	HTY	Class II	2021-01-29
K201801	Rapid Acoustic Pulse Device	Soliton, Inc.	GEX	Class II	2021-01-29
K201752	Disposable Pre-calibrated Suction	Brainlab, Inc.	HAW	Class II	2021-01-29
K201620	Luna® G3 BPAP 25A	3B Medical Inc	BZD	Class II	2021-01-29
K201418	Sunset Heated CPAP Tube	SUNSET HEALTHCARE SOLUTIONS, Inc.	BZE	Class II	2021-01-29
K201411	Visage Breast Density	Visage Imaging, Inc	QIH	Class II	2021-01-29
K200429	BEE Cages	Ngmedical GmbH	ODP	Class II	2021-01-29
K192650	i_Space 1.5T Superconducting Magnetic Resonance Imaging System	MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd	LNH	Class II	2021-01-29
K191878	DEX Device	Dex Surgical	GEI	Class II	2021-01-29
K190677	EndoClot	Endoclot Plus Co., Ltd.	QAU	Class II	2021-01-29
K203840	BOSS 8F Balloon Guide Catheter	Marblehead Medical	QJP	Class II	2021-01-28
K203507	Vitality® Spinal Fixation System	Highridge Medical, LLC	NKB	Class II	2021-01-28
K203474	Biomet Microfixation RibFix Advantage System	Biomet Micofixation	HRS	Class II	2021-01-28
K203223	Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide	STERIS Corporation	NZA	Class II	2021-01-28
K202892	Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s	Edan Instruments, Inc.	MWI	Class II	2021-01-28
K202754	MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU	eResearchTechnology GmbH	BTY	Class II	2021-01-28
K202524	Standard Sterilizable Tray	Implant Direct Sybron Manufacturing LLC	KCT	Class II	2021-01-28
K201608	GenesisZr UHT700 Zirconia	United Dental Resources Corporation	EIH	Class II	2021-01-28
K201016	LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)	HuiZhou Foryou Medical Devices Co., Ltd.	FRO	Unclassified	2021-01-28
K200384	HipXpert 3D Display and Anchoring Application	Surgical Planning Associates	OSF	Class II	2021-01-28
K200289	Michler-Kapp Cardiovascular Vent Catheter	Kapp Surgical GmbH	DWF	Class II	2021-01-28
K203405	EVOS Large Fragment Plating System	Smith & Nephew, Inc.	HRS	Class II	2021-01-27
K193586	Vivo 45 LS	Breas Medical AB	NOU	Class II	2021-01-27
K193387	Arm Electronic Sphygmomanometer	Shenzhen Changkun Technology Co., Ltd.	DXN	Class II	2021-01-27
K193386	Wrist Electronic Sphygmomanometer	Shenzhen Changkun Technology Co., Ltd.	DXN	Class II	2021-01-27
K203849	General Radiography CXDI-CS01	Canon, Inc.	MQB	Class II	2021-01-26
K203803	VASOBand Vascular Compression Device	Vasoinnovations Inc.	DXC	Class II	2021-01-26
K203482	M.U.S.T. Pedicle Screw Extension and Long Tab Implants	Medacta International SA	NKB	Class II	2021-01-26
K203104	IBM iConnect Access	Merge Healthcare Incorporated	LLZ	Class II	2021-01-26
K202934	Blood Pressure Monitor	Bioland Technology Ltd.	DXN	Class II	2021-01-26
K202199	Btl-899St	Btl	GEI	Class II	2021-01-26
K201300	Airway Mobilescope	Olympus Medical Systems Corp.	EOQ	Class II	2021-01-26
K200922	Altus Spine HA Pedicle Screw System	Altus Partners	NKB	Class II	2021-01-26
K203797	vatech A9 (Model : PHT-30CSS)	Vatech Co., Ltd.	OAS	Class II	2021-01-25
K203747	Non-Contact Forehead Thermometer (Models UT306H & UT308H)	Uni-Trend Technology (China) Co., Ltd.	FLL	Class II	2021-01-25
K203453	BD Hypodermic Syringe	Becton Dickinson & Co	FMF	Class II	2021-01-25
K203327	VERTACONNECT TLIF Cage	Signus Medizintechnik GmbH	MAX	Class II	2021-01-25
K202856	Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28	Edan Instruments, Inc.	IYN	Class II	2021-01-25