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 1511 of 3531

510(k) clearances, page 1511 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022452	Porta Op Solder M-1	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-11
K022451	Auropal Solder W-2	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-11
K022331	Advia 120 Hematology System, Cerebrospinal Fluid Method	Bayer Diagnostics Corp.	GKL	Class II	2002-09-11
K022241	Vertis Pnt Control Unit, Model Cu 100; Vertis Pnt Safeguide-Cervical, Model Sg 102-Xxx	Vertis Neuroscience, Inc.	NHI	Class II	2002-09-11
K022067	Convoy Advanced Delivery Sheath	Boston Scientific Corporation	DBY	Class I	2002-09-11
K022051	Soundvaser System	Solta Medical, Inc.	QPB	Class II	2002-09-11
K022022	Jostra Vent Catheters, Models Lv & Hkv	Jostra AG	DWF	Class II	2002-09-11
K021946	Cell Robotics Ultra-Light Peel Laser System	Cell Robotics, Inc.	GEX	Class II	2002-09-11
K021942	Radionics Pole Needles	Radionics, A Division of Tyco Healthcare Group LP	GXI	Class II	2002-09-11
K021485	Biosomnia	Oxford Biosignals Limited	OMC	Class II	2002-09-11
K021044	Madett	Wolfe Tory Medical, Inc.	BTR	Class II	2002-09-11
K012473	Vident Hextop, Synocta in-Ceram Blank/coping Manufactured by Vident	Vident	DZE	Class II	2002-09-11
K022782	Dualmesh Emerge & Emerge Plus Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	2002-09-10
K022664	Pga (Polyglycolic) Synthetic Absorbable Suture U.s.p.	Arc Medical Supplies (Beijing) Co, Ltd.	GAM	Class II	2002-09-10
K022230	Normed Mini External Fixator System	Osteomedics, Inc.	HRS	Class II	2002-09-10
K022158	Iqm (Intelligent Quality Management) on the Gem Premier 3000, Cvp (Calibration Validation Product)	Instrumentation Laboratory Co.	CGA	Class II	2002-09-10
K022127	Avagen Wound Dressing	Integra LifeSciences Corporation	KGN	Unclassified	2002-09-10
K022104	Dermapal, Uva 50Hz, Uva 60Hz, Uvb Broad Band 50Hz, Uvb Broad Band 60Hz,uvb Narrow Band 50Hz, Uvb Narrow Band 60Hz	The Daavlin Distributing Co.	FTC	Class II	2002-09-10
K022037	Xltek Sleep System	Excel Tech., Ltd.	OLV	Class II	2002-09-10
K021985	Medx Lcs Laser Series	Medx Electronics, Inc.	NHN	Class II	2002-09-10
K021929	Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System	TORNIER Inc.	LFL	Unclassified	2002-09-10
K021623	Ucr Spinal System, 5.5Mm, 8.0Mm Screws & Instruments	Iame, Inc.	MNH	Class II	2002-09-10
K021334	Wiener Lab. Ca-Color Arsenazo III Aa, Model 4X50 Ml Cat.nr. 1152004, Wiener Lab.ca-Color Arsenazo III Aa, Model 8 X 20 5	Wiener Laboratories Saic	CJY	Class II	2002-09-10
K022833	Benjamin Envoy Phaco Handpiece	Benjamin Biomedical, Inc.	HQC	Class II	2002-09-09
K022325	Normed Titanium Osteotomy Plating System	Osteomedics, Inc.	HRS	Class II	2002-09-09
K022323	Normed Titanium Rondo Fix Fusion Plates and Screw System	Osteomedics, Inc.	HRS	Class II	2002-09-09
K022273	Cranial Symmetry System	Beverly Hills Prosthetics Orthotics, Inc.	MVA	Class II	2002-09-09
K022182	Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System	Abbott Medical	NBW	Class II	2002-09-09
K022175	P4 Physio	Valmed SRL	IPF	Class II	2002-09-09
K021218	Elecsys Cortisol Test System	Roche Diagnostics GmbH	JFT	Class II	2002-09-09
K020972	Wako RF-Ha (2), RF Calibrator, RF Calibrator Set	FUJIFILM Healthcare Americas Corporation	DHR	Class II	2002-09-09
K020631	Iplan	Brainlab, Inc.	HAW	Class II	2002-09-09
K013705	Act III Ventricular Catheter	Innerspace, Inc.	GWM	Class II	2002-09-09
K022890	Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate Inc	JEY	Class II	2002-09-06
K022858	Supernova Diagnostic Ultrasound Scanning System	Novasonics, Inc.	IYN	Class II	2002-09-06
K022796	Cercon Ceram S Porcelain	Dentsply Intl.	EIH	Class II	2002-09-06
K022789	Viatronix V3d Explorer	Viatronix, Inc.	LLZ	Class II	2002-09-06
K022735	Microplex Coil System (Mcs) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit	Terumo Cardiovascular Systems Corporation	HCG	Class II	2002-09-06
K022726	Stayfuse Gt-Ip	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	2002-09-06
K022720	Ctl-63-8 Cervical/thoracic/lumbar Spine Array Coil	Mri Devices Corp.	MOS	Class II	2002-09-06
K022669	8 Channel Cardiac Phased Array Coil	GE Healthcare	MOS	Class II	2002-09-06
K022658	Lr Dicom Controller	Agfa Corp.	LMC	Class II	2002-09-06
K022649	Cook-Swartz Doppler Flow Probe	Cook Vandergrift, Inc.	ITX	Class II	2002-09-06
K022635	Kuske Breast Applicator Set, Model 189.006	Nucletron BV	JAQ	Class II	2002-09-06
K022619	Powder Free Nitrile Examination Gloves	Ar Alliance Healthcare Sdn. Bhd.	LZA	Class I	2002-09-06
K022618	X-Scribe II	Mortara Instrument, Inc.	DPS	Class II	2002-09-06
K022408	Cerec Vitablocks Mk2	B.B.'S Prophy Shop	EIH	Class II	2002-09-06
K022247	G-Sperm, Model 10032	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K022245	G-Fert, Model 10033	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K022244	G-1 Version 3, Model 10048	Vitrolife Sweden AB	MQL	Class II	2002-09-06