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 1449 of 3531

510(k) clearances, page 1449 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031582	Wrist Blood Pressure Monitor & Fat Meter, Model Wt-20	Nihon Seimitsu Sokki Co., Ltd.	MNW	Class II	2003-08-01
K031578	Micrus Microcoil Systems, Models Hel, Sph, Str, Fsr and Hsr	Micrus Corp.	HCG	Class II	2003-08-01
K031561	Cardiosoft/case Cardiac Testing System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2003-08-01
K031532	Satureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft Contact Lens for Daily Wear	Metro Optics of Austin, Inc.	LPL	Class II	2003-08-01
K031483	Medrad Manual Syringe Loader	Medrad, Inc.	DXT	Class II	2003-08-01
K031451	Xtracxl Plus Excimer Laser System, Model Al7000	Photo Medex, Inc.	GEX	Class II	2003-08-01
K031387	Isolette Infant Incubator, Model C2000e	Hill-Rom Manufacturing, Inc.	FMZ	Class II	2003-08-01
K031323	Dbt, Dynamic Bubble Trap	Convergenza AG	DTM	Class II	2003-08-01
K031049	Guglielmi Detachable Coil (Gdc)	Boston Scientific Corporation	HCG	Class II	2003-08-01
K030517	Ball Recording Electrode/stimulation Probe	Viasys Healthcare GmbH	GZK	Class II	2003-08-01
K030487	R 72	Ralco S.r.l.	KPW	Class II	2003-08-01
K024283	Cardiodirect, Models 12M, 12I, 12S	Reynolds Medical, Ltd.	DPS	Class II	2003-08-01
K014241	Coolgard 3000, Cooline, Start-Up, Models 3000, Cl-2085B, Cl-2295A, Cg-500D	Alsius Corp.	NCX	Class II	2003-08-01
K012715	Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II	Hygia Health Services, Inc.	NLF	Class II	2003-08-01
K032188	Nichols Advantage Aldosterone Assay	Nichols Institute Diagnostics	CJM	Class II	2003-07-31
K032123	Shockwave Suspension Wheelchair	Per4max Medical, LLC	IOR	Class I	2003-07-31
K031829	Hemosil Factor IX Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2003-07-31
K031704	Filmless Clinic	Connect Imaging, Inc.	LLZ	Class II	2003-07-31
K031602	Microscan Synergies Plus Gram Negative Mic/combo Panels with Nitrofurantoin (1-256 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2003-07-31
K031576	Spartan Orthopaedic Wrist Brace, Model Sct-1	Surgitech, Inc.	IQI	Class I	2003-07-31
K031480	Global Modular Replacement System Pediatric Tibial Bearing Component	Howmedica Osteonics Corp	KRO	Class II	2003-07-31
K031448	Rsv (Radiology System Visiodent	Visiodent SA	EHD	Class II	2003-07-31
K031309	Kuann Dah, Cool Tank Motorized Scooter, Ks4l320	Kuann Dah Industry Co., Ltd.	INI	Class II	2003-07-31
K030758	Coach 888	Wheelchair & Scooter Express	INI	Class II	2003-07-31
K030671	Medtronioc 7F Launcher Biopsy Guide Catheter, Model La7rvbb, Medtronic 8F Launcher Biopsy Catheter, Model La8rvbb	Medtronic, Inc.	DQY	Class II	2003-07-31
K021362	Lifeport, Kidney Perfusion Transporter (Ktr)	Organ Recovery Systems, Inc.	KDN	Class II	2003-07-31
K032089	Roche Diagnostics Elecsys Precicontrol Cardiac	Roche Diagnostics GmbH	JJY	Class I	2003-07-30
K032082	Aurora	Aurora Imaging Technology, Inc.	LNH	Class II	2003-07-30
K032058	Modification to Reprocessed Synthes External Fixation Devices	Alliance Medical Corp.	KTT	Class II	2003-07-30
K032045	8 Channel Cardiac Phased Array Coil	GE Healthcare	MOS	Class II	2003-07-30
K031991	Dxaview Spine and Hip, Model Qct-3D Plus	Image Analysis, Inc.	KGI	Class II	2003-07-30
K031987	Powerheart AED G3, Model 9300	ZOLL Medical Corporation	MKJ	Class III	2003-07-30
K031780	Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2003-07-30
K031757	Peek Tetris Spinal Implant	Signus Medical, LLC	MQP	Class II	2003-07-30
K031731	Mr Fiber Optic ECG Gating System	Sa Instruments, Inc.	LNH	Class II	2003-07-30
K031727	Pasco Mic and Mic/id Panels, Gemifloxacin	Pasco Laboratories, Inc.	JWY	Class II	2003-07-30
K031699	Bd Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5-16/304Ug/ml	Becton Dickinson & Co	LON	Class II	2003-07-30
K031656	BIPAP Harmony Ventilatory Support System	Respironics, Inc.	MNS	Class II	2003-07-30
K031534	Cyclase Activating Pth (Cap) Immunoradiometric (Irma) Assay Kit, Model 3Kg001	Scantibodies Laboratory Inc.	CEW	Class II	2003-07-30
K031411	Mini Statco2 CO2 Detector, Model 10-55371	Mercury Medical	CCK	Class II	2003-07-30
K031381	Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments	Seaspine, Inc.	MNI	Class II	2003-07-30
K031194	Spirosoft	Viasys Healthcare GmbH	BTY	Class II	2003-07-30
K030278	Sauflon Multipurpose Solution - No Rub	Sauflon Pharmaceuticals, Ltd.	LPN	Class II	2003-07-30
K030268	Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters	C.R. Bard Inc	MPB	Class II	2003-07-30
K030058	Earlydetect Menopause Test for Fsh	Early Detect, Inc.	CGJ	Class I	2003-07-30
K032062	Stellartech Coagulation System, Models (1100C-115 & 1100C-230)	Stellartech Research Corp.	GEI	Class II	2003-07-29
K031891	Virtuosaph	Terumo Cardiovascular Systems Corporation	GCJ	Class II	2003-07-29
K031861	Mix2vial Transfer Device	West Pharma. Services IL, Ltd.	LHI	Class II	2003-07-29
K031658	Benco Spherical	Southern Dental Industries, Inc.	EJJ	Class II	2003-07-29
K031647	Biosign Ssi Biological Test Pack with Instant Readout Integrator	Getinge USA, Inc.	JOJ	Class II	2003-07-29