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 339 of 3528

510(k) clearances, page 339 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211655	aPROMISE	Exini Diagnostics AB	LLZ	Class II	2021-07-27
K211325	Senhance Surgical System	Asensus Surgical, Inc.	NAY	Class II	2021-07-27
K211279	Volpara Imaging Software	Volpara Health Technologies Limited	LLZ	Class II	2021-07-27
K211247	Pet Vcar	GE Medical Systems SCS	KPS	Class II	2021-07-27
K210884	1Derful HS, 1Derful HT	1derful, Inc.	EIH	Class II	2021-07-27
K210791	Us2.v1	Eko.Ai Pte Ltd. D/B/A Us2.Ai	QIH	Class II	2021-07-27
K210736	doctorgram Stethoscope DES-I	Gv Concepts	DQD	Class II	2021-07-27
K210664	DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)	Ra Medical Systems,Inc	PDU	Class II	2021-07-27
K210635	Route 92 Medical Full Length 088 Access System	Route 92 Medical, Head Quarters	QJP	Class II	2021-07-27
K210469	Insight Agile DRF	Imaging Engineering, LLC	JAA	Class II	2021-07-27
K210016	Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System	Integra LifeSciences Corporation	HRS	Class II	2021-07-27
K201326	Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair	Psychemedics Corp.	DJG	Class II	2021-07-27
K211643	Vision Monitor - MonpackONE	Metrovision	GWE	Class II	2021-07-26
K210477	AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE	AtriCure, Inc.	OCL	Class II	2021-07-26
K210412	Pac-Dent Ceramic Nanohybrid Resin	Pac-Dent Inc.	EBF	Class II	2021-07-26
K200129	OncoMate MSI Dx Analysis System	Promega Corporation	PZJ	Class II	2021-07-26
K211984	MASC Surgical Mask	Mid-America Safety Corp	FXX	Class II	2021-07-25
K211363	Medical Face Mask	Hubei Kangning Protective Products Co., Ltd	FXX	Class II	2021-07-24
K211262	Disposable Vinyl Nitrile Synthetic Gloves Powder Free	Tangshan Hongyun Healthcare Products Co., Ltd.	LYZ	Class I	2021-07-24
K212052	HMB32 Dialysis Solution	Haemopharm Biofluids SRL	KPO	Class II	2021-07-23
K212030	Flex-Thread™ Distal Fibula lntramedullary Nail System	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HSB	Class II	2021-07-23
K211951	GI Genius	Cosmo Artificial Intelligence - Ai, Ltd.	QNP	Class II	2021-07-23
K211602	Klassic Knee System	Total Joint Orthopedics, Inc.	JWH	Class II	2021-07-23
K211386	MySpine WebPlanner & MyBalance	Medacta International SA	LLZ	Class II	2021-07-23
K211316	da Vinci SP Surgical System (SP1098)	Intuitive Surgical, Inc.	NAY	Class II	2021-07-23
K211249	Altor Safety 3-Ply Surgical Mask (Model:62222)	Altor Safety	FXX	Class II	2021-07-23
K211012	Nitrile Patient Examination Gloves	Huayuan Medical Technology(Shangqiu) Co., Ltd.	LZA	Class I	2021-07-23
K210903	IS Multi Unit Abutment System	Neobiotech Co., Ltd.	NHA	Class II	2021-07-23
K210468	SC1 Handheld Ultrasound Imaging System (Model: SC1)	Fcu Co., Ltd.	IYO	Class II	2021-07-23
K210382	Blustone Synergy Diamond SA Cervical System	Blustone Synergy, LLC	OVE	Class II	2021-07-23
K210311	Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.	Shenzhen Mismon Technology Co., Ltd.	OHT	Class II	2021-07-23
K210185	CardioCurve Steerable Sheath	Talon Surgical	DYB	Class II	2021-07-23
K210159	IntraLock System	Fusion Orthopedics, LLC	HWC	Class II	2021-07-23
K202727	Peregrine Endoscopy System	3NT Medical Ltd.	EOB	Class II	2021-07-23
K202612	Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)	Thermo Fisher Scientific Oy	JWY	Class II	2021-07-23
K202296	Infrared Forehead Thermometer, Model BSX976	Shenzhen BSX Technology Electronics Co.,Ltd	FLL	Class II	2021-07-23
K202060	Disposable IV catheter	Shinva Ande Healthcare Apparatus Co., Ltd.	FOZ	Class II	2021-07-23
K201887	VS Newborn Heart Rate Monitor	Surepulse Medical Limited	DQA	Class II	2021-07-23
K201265	Disposable Microwave Therapeutic Antennas	Nanjing Eco Microwave System Co., Ltd.	NEY	Class II	2021-07-23
K201160	HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)	M.I.Tech Co Ltd	ESW	Class II	2021-07-23
K212008	Reveal LINQ Insertable Cardiac Monitor	Medtronic, Inc.	MXD	Class II	2021-07-22
K211968	NIO+ Adult	Waismed Ltd.	FMI	Class II	2021-07-22
K211944	Medline UNITE® Digital Fusion Screw System	MEDLINE INDUSTRIES, LP - Northfield	HWC	Class II	2021-07-22
K211939	ExacTrac Dynamic	Brainlab, Inc.	IYE	Class II	2021-07-22
K211688	DC-Air and Athlos-1 and Athlos-Air	Athlos Oy	MUH	Class II	2021-07-22
K211633	Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2021-07-22
K211220	Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs	Guangdong Kingfa Sci.&tech.co.,Ltd.	LZA	Class I	2021-07-22
K210579	WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System	OTU Medical Inc	FGB	Class II	2021-07-22
K210415	QSM software, QSMetric	Medimagemetric, LLC	LNH	Class II	2021-07-22
K210391	Single-use medical face mask	Zhuhai Herald Datanetics Limited.	FXX	Class II	2021-07-22