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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1345 of 3531

510(k) clearances, page 1345 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042854	Stereotaxis Endovascular Guide Wire	Stereotaxis Inc	DQX	Class II	2005-02-08
K042808	Advia Ims Carbamazepine Method	Medrad, Inc.	KLT	Class II	2005-02-08
K042807	Advia Ims Valproic Acid Method	Medrad, Inc.	LEG	Class II	2005-02-08
K040788	Calm Patterns, Version 01.00.00	PeriGen Solutions Ltd.	HGM	Class II	2005-02-08
K050257	Lin/liou Orthodontic Mini Anchor System (Lomas) (Sterile)	Mondeal Medical Systems GmbH	DZE	Class II	2005-02-07
K050160	Katana Zirconia	Noritake Co., Inc.	EIH	Class II	2005-02-07
K050155	Powdered Vinyl Patient Examination Gloves, White (Non-Colored)	Zibo Zhuangyuan Plastic & Rubber Co., Ltd.	LYZ	Class I	2005-02-07
K050154	Powder-Free Vinyl Patient Examination Gloves, White (Non-Colored)	Zibo Zhuangyuan Plastic & Rubber Co., Ltd.	LYZ	Class I	2005-02-07
K050152	Palm Pro Premium, Model 6Pf1 & Palm Pro, Model 6Pf2, Latex Exam Glove	Dipped Products (Thailand) Ltd	LYY	Class I	2005-02-07
K050090	Gel Mark V	Senorx, Inc.	NEU	Class II	2005-02-07
K050044	Medtronic Clip Gun Kit	Medtronic Neurosurgery	HBO	Class II	2005-02-07
K043405	Nuvasive Coroent System	NuVasive Inc	MQP	Class II	2005-02-07
K043386	Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and Tdm Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	LEH	Class II	2005-02-07
K043384	Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and Tdm Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	LDO	Class II	2005-02-07
K043327	Online Dat Benzodiazepines Plus	Roche Diagnostics GmbH	JXM	Class II	2005-02-07
K043316	Rabea Spinal Implant	Signus Medizintechnik GmbH	MQP	Class II	2005-02-07
K043236	Frequency Doubled Nd: Yag Photocoagulator, Model Vitra	Quantel Medical	HQF	Class II	2005-02-07
K043174	Stealth Fusion System, Model Rr 1000	R&R Medical Corporation Ltd.	KTT	Class II	2005-02-07
K043091	Navigus Nexdrive, Model Mi-3000	Image-Guided Neurologics, Inc.	HAW	Class II	2005-02-07
K043051	Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121	Phamatech Inc.	DJG	Class II	2005-02-07
K042073	Olsen Medical Anterior Cervical Vertebrae Plate System	Olsen Medical	KWQ	Class II	2005-02-07
K041798	Atalia Titanium Surgical Mesh	Us Spinal Technologies, LLC	MQP	Class II	2005-02-07
K050055	Ge Datex-Ohmeda Aestiva/5 MRI Anesthesia System	GE Healthcare	BSZ	Class II	2005-02-04
K043605	Inscope 3-Stage Balloon Dilator	Cordis Europa, N.V.	KNQ	Class II	2005-02-04
K043499	Powder Free Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-Large	Shijaizhuang Brilliant Ocean Plastic Co., Ltd.	LYZ	Class I	2005-02-04
K043446	Emmebi Central Venous Catheter Kit with Lestep Safety Introducer	Emmebi SRL	FOZ	Class II	2005-02-04
K043219	Affinity (Cabinet Name), Ac440, Hit440, or the Combination of Systems	Interacoustics a/S	EWO	Class II	2005-02-04
K041892	Zoll AED Pro External Defibrillator	ZOLL Medical Corporation	MKJ	Class III	2005-02-04
K050161	System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy	ConMed Corporation	GEI	Class II	2005-02-03
K050147	Trellis-8 Peripheral Infusion System	Bacchus Vascular, Inc.	QEY	Class II	2005-02-03
K050059	G-Light	GC America Inc.	EBZ	Class II	2005-02-03
K050025	Nanoss Bone Void Filler	Angstrom Medica, Inc.	MQV	Class II	2005-02-03
K050015	Modified Acumen Sheath, Model Ttwo767	Acumen Medical, Inc.	DYB	Class II	2005-02-03
K043517	Transmitter, Zs-940Pa Series	Nihon Kohden America Inc	DRT	Class II	2005-02-03
K043469	Syngo Inspace 4D	Siemens AG Medical Solutions	JAK	Class II	2005-02-03
K043371	Biomerix Vascular Occlusion Device and Loader	Biomerix Corporation	KRD	Class II	2005-02-03
K043321	Modification to: Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2005-02-03
K043257	Real-Time Position Management (Rpm) System	Ep Technologies, Inc.	DRF	Class II	2005-02-03
K043200	Sign Fin Nail	Surgical Implant Generation Network (Sign)	HSB	Class II	2005-02-03
K043185	Synthes 3.5Mm Cortex Screws	Synthes (USA) Products LLC	HWC	Class II	2005-02-03
K043126	Assist Header Cleaner	Alcavis International, Inc.	LIF	Class II	2005-02-03
K043066	Pioneer Anterior Cervical Plate System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2005-02-03
K042780	Neoscope - Endoscopic Diagnostic & Treatment System	Prosurg, Inc	FAJ	Class II	2005-02-03
K042719	Home Health Power Wheelchair, Model Hc-200	Home Health Technology Co., Ltd.	ITI	Class II	2005-02-03
K041224	Foothills Surgical Drapes	Foothills Industries, Inc.	KKX	Class II	2005-02-03
K040318	Medcomp Split-Cath II	Medcomp	MSD	Class II	2005-02-03
K050126	Ge Logiq Twin	General Electric Co.	IYN	Class II	2005-02-02
K043369	Cervex-Brush Combi	Rovers Medical Devices B.V.	HHT	Class II	2005-02-02
K043246	Brachysource Brachytherapy Seed Implants	C.R. Bard Inc	KXK	Class II	2005-02-02
K040303	59% Extreme H2o (Hioxifilcon a) Soft Contact Lens	Hydrogel Vision Corporation	LPL	Class II	2005-02-02