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 2026-10-19, 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 481 of 3529

510(k) clearances, page 481 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K181870	Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use	Wuhan W.E.O Science & Technology Development Co., Ltd.	FPA	Class II	2019-02-26
K190151	COBRA Fusion Ablation System	AtriCure, Inc.	OCL	Class II	2019-02-25
K190071	Perla® Posterior Cervico-Thoracic Fixation System	Spineart SA	NKG	Class II	2019-02-25
K183698	Zap-X Radiosurgery System	Zap Surgical Systems Inc.	IYE	Class II	2019-02-25
K183290	Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200	Thrombolex, Inc.	QEY	Class II	2019-02-25
K183179	CAPERE Thrombectomy System	Vascular Medcure, Inc.	QEW	Class II	2019-02-25
K182976	SpringTMS	eNeura Inc	OKP	Class II	2019-02-25
K183693	Doctor Tecar	Mectronic Medicale S.r.l.	PBX	Class II	2019-02-22
K183640	Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2019-02-22
K183621	EMMA 1.5T MRI System	Time Medical Limited	LNH	Class II	2019-02-22
K183588	Choice Spine Hawkeye Vertebral Body Replacement (VBR) System	Choicespine, LP	MQP	Class II	2019-02-22
K183365	Libertas Acetabular Hooded Liner	Maxx Orthopedics Inc.	LZO	Class II	2019-02-22
K183240	Empower RF Catheter	Broncus Medical Inc	GEI	Class II	2019-02-22
K182859	Babyleo TN500	Drägerwerk AG & Co. KGaA	FMZ	Class II	2019-02-22
K182825	FUJIFILM Ultrasonic Endoscope	FUJIFILM Corporation	EOQ	Class II	2019-02-22
K182643	IRIS 1.0 System	Intuitive Surgical, Inc.	LLZ	Class II	2019-02-22
K182542	The EPAD 2 System	Safeop Surgical, Inc.	GWF	Class II	2019-02-22
K182488	Reprocessed Response Diagnostic Electrophysiology Catheter	Innovative Health, LLC.	NLH	Class II	2019-02-22
K182406	Altus Spine Interbody Fusion System	Altus Partners	MAX	Class II	2019-02-22
K181551	DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette	Runbio Biotech Co.,Ltd	LCX	Class II	2019-02-22
K181310	HeartCheck Cardi Beat ECG Monitor with GEMS Mobile	Cardiocomm Solutions, Inc.	DXH	Class II	2019-02-22
K190255	Sensus Healthcare TVM Balloon Applicator	Sensus Healthcare	JAD	Class II	2019-02-21
K190105	ZOOM Aspiration Pump	TAIWAN BIOMATERIAL Company, Ltd.	JCX	Class II	2019-02-21
K183279	HEALIX Ti ANCHOR with DYNACORD	Medos International SARL	MBI	Class II	2019-02-21
K183255	Coag-Sense Prothrombin Time (PT) / INR Monitoring Device	Coagusense Inc	GJS	Class II	2019-02-21
K182665	Sensus TPS Workstation	Sensus Healthcare	MUJ	Class II	2019-02-21
K182641	Sensus IORT System	Sensus Healthcare	JAD	Class II	2019-02-21
K182578	Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device	Devon Medical Products (Jiangsu) Ltd	JOW	Class II	2019-02-21
K173418	NobelParallel Conical Connection	Nobel Biocare AB	DZE	Class II	2019-02-21
K183415	VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)	bioMerieux, Inc.	LON	Class II	2019-02-20
K181989	MRIdian Linac System	Viewray Systems, Inc.	IYE	Class II	2019-02-20
K180953	AnyCheck IMT-100	Dms Co., Ltd.	EKX	Class I	2019-02-20
K183594	Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J	New Deantronics Taiwan Ltd.	GEI	Class II	2019-02-19
K183241	BrainScope TBI (Model: Ahead 400)	Brainscope	PIW	Class II	2019-02-19
K183055	Vector Hammertoe Correction System	Nvision Biomedical Technologies, Inc	HWC	Class II	2019-02-19
K181872	MIS Bunion System	Crossroads Extremity Systems LLC	HRS	Class II	2019-02-19
K181409	Pressure Therapy System PT1003	Xiamen Senyang Co., Ltd	IRP	Class II	2019-02-19
K180346	Byte Aligner System	Straight Smile, LLC	NXC	Class II	2019-02-19
K182768	TMS-Cobot TS MV	Axilum Robotics	QFF	Class II	2019-02-17
K183704	RX-1 Rhythm Express Remote Cardiac Monitoring System	VivaQuant, Inc	DXH	Class II	2019-02-16
K183555	GEM Premier ChemSTAT	Instrumentation Laboratory Co.	JFY	Class II	2019-02-16
K183549	GEM Premier ChemSTAT	Instrumentation Laboratory Co.	JGS	Class II	2019-02-16
K183546	GEM Premier ChemSTAT	Instrumentation Laboratory Co.	CGA	Class II	2019-02-16
K181362	TEMA Elbow System	Lima Corporate S.p.A.	JDC	Class II	2019-02-16
K181163	Wu's Powered Wheelchair	Wu's Tech Co., Ltd.	ITI	Class II	2019-02-16
K180509	Quo-Test A1c System	Ekf Diagnostic GmbH	LCP	Class II	2019-02-16
K190138	MAGNETOM Aera	Siemens Medical Solutions USA, Inc.	LNH	Class II	2019-02-15
K183556	oCare Wrist Pulse Oximeter	Taiwan Biophotonic Corporation	DQA	Class II	2019-02-15
K183324	Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL	Thermo Fisher Scientific Oy	JWY	Class II	2019-02-15
K183225	Stabil Orthopaedic Solutions Total Knee System	Stabil Orthopaedic Solutions, LLC	JWH	Class II	2019-02-15