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 1298 of 3531

510(k) clearances, page 1298 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050296	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2005-11-03
K050271	Kowa Genesis-D Hand-Held Retinal Camera	Kowa Co., Ltd.	HKI	Class II	2005-11-03
K052880	Datex-Ohmeda S/5 Interface Module E-Int	GE Healthcare	CCK	Class II	2005-11-02
K052809	Sauflon Flat Coloured Lens Case	Sauflon Pharmaceuticals, Ltd.	LRX	Class II	2005-11-02
K052801	Intellivue Patient Monitors with Release C.02, Models Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 and Mp90	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2005-11-02
K052722	Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others	Abbott Medical	FPA	Class II	2005-11-02
K052507	Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear	The Lagado Corp.	HQD	Class II	2005-11-02
K052268	Visucam Pro Nm	Carl Zeiss Meditec Inc	HKI	Class II	2005-11-02
K052253	Modification to: Dryac Acid Concentrate Mix for Bicarbonate Hemodialysis	Gambro Renal Products	KPO	Class II	2005-11-02
K052213	Navigation Sw Hip 3.1 on Ci	Brainlab, Inc.	HAW	Class II	2005-11-02
K052195	Ez-Mio Manual Driver	Teleflex Medical	FMI	Class II	2005-11-02
K051799	Disposable Ct/mr Syringes for Nemoto Injectors	Coeur, Inc.	DXT	Class II	2005-11-02
K051561	Asahi Angiographic Catheter	Asahi Intecc Co., Ltd.	DQO	Class II	2005-11-02
K051206	Y2k2 Enternal Tube Fluid Filter	Moss Medical Products	KNT	Class II	2005-11-02
K050571	Absolute America	Eurodent, Inc.	EIA	Class I	2005-11-02
K052981	Bis EEG Monitor, Model Bisx4	Aspect Medical Systems, Inc.	OLW	Class II	2005-11-01
K052909	Evenflo Elan Breast Pump	Evenflo Company, Inc.	HGX	Class II	2005-11-01
K052883	Cardioserver	Datrix LLC	DQK	Class II	2005-11-01
K052827	Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens	Medrad, Inc.	MOS	Class II	2005-11-01
K052815	Qms Amikacin Reagents	Seradyn, Inc.	KLQ	Class II	2005-11-01
K052802	Manan Bio-Cut Soft Tissue Biopsy Needle	Argon Medical Devices, Inc	KNW	Class II	2005-11-01
K052756	Datex-Ohmeda S/5 Memory Module, E-Mem	GE Healthcare	MHX	Class II	2005-11-01
K052470	F1 Series Dental Chairs with Operative Unit	Shanghai Fimet Medical Instrument Co., Ltd.	EIA	Class I	2005-11-01
K052370	Cp Bracket System	Dentsply International, Inc.	DYW	Class II	2005-11-01
K051804	Abl80 Flex Analyzer	Sendx Medical, Inc.	CHL	Class II	2005-11-01
K052979	1125 Xsb Xenon Fiber-Optic Light Source	Isolux, LLC	HBI	Class II	2005-10-31
K052911	Accuvix Xq Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2005-10-31
K052890	Non-Sterile Powder-Free Nitrile Examination Glove, Blue, with Vitamin E	Siam Sempermed Corp., Ltd.	LZA	Class I	2005-10-31
K052775	Syngo Multimodality Workplace (Syngo Mm Wp)	Siemens AG Medical Solutions	LLZ	Class II	2005-10-31
K052770	Pathformer	Path Scientific	NWF	Class I	2005-10-31
K052379	Mim 3.5 (Circa)	MIM Software Inc	LLZ	Class II	2005-10-31
K052106	Simile Flow	Pentron Clinical Technologies	EBF	Class II	2005-10-31
K052105	Water Filled Teether	Royal Industries (Thailand) Public Co., Ltd.	KKO	Class II	2005-10-31
K051637	Dsnare, Model 00711087	United States Endoscopy Group, Inc.	FCK	Class II	2005-10-31
K051589	Slimmanager, Model Sm-X, Sm-E	Aiia Communication, Inc.	MNW	Class II	2005-10-31
K051580	Vp Sheath	Flowcardia, Inc.	DQY	Class II	2005-10-31
K052982	Roche Diagnostics Cobas Elecsys Prolactin II Calset	Roche Diagnostics GmbH	JIT	Class II	2005-10-28
K052855	Starspeed Series CT Scanner Systems	GE Healthcare	JAK	Class II	2005-10-28
K052757	Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter	BIOTRONIK AG	LIT	Class II	2005-10-28
K052747	Modification To:cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2005-10-28
K052713	Model 3300E/er Monoplace Hyperbaric Oxygen Chamber	Sechrist Industries Inc	CBF	Class II	2005-10-28
K052473	Cx 250 C Plus with Gammaxp Software, Model 0121 0000	Inter Medical Medizintechnik GmbH	IYX	Class I	2005-10-28
K052227	Respcare Face Mask	Respcare, Inc.	BZD	Class II	2005-10-28
K052112	Xltek Xcalibur EMG / Lt, Model Pk1p33, Pk1059	Excel Tech., Ltd.	IKN	Class II	2005-10-28
K052028	Bonart Art-M3ii & M4 Ultrasonic Scaler Units with Accessories (Inserts)	Bonart Co. Ltd.	ELC	Class II	2005-10-28
K051476	Uni-Vent Model 73X	ZOLL Medical Corporation	BTL	Class II	2005-10-28
K051276	Hysafe Micro Modular Forceps and Scissors System	Richard Wolf Medical Instruments Corp.	OCZ	Class II	2005-10-28
K050233	Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000Ai	Omron Healthcare Co., Ltd.	DXN	Class II	2005-10-28
DEN050006	Cardiomems Endosensor with Delivery System and Endosensor Electronics System	Cardiomems, Inc.	NQH	Class II	2005-10-28
K052904	Virtual Medical Systems Model Vt3000	Scientific Imaging, Inc.	JXE	Class II	2005-10-27