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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 923 of 3530

510(k) clearances, page 923 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112822	Sleepstrip II	S.L.P., Ltd.	MNR	Class II	2011-12-27
K112575	Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio	Geistlich Pharma AG	NPM	Class II	2011-12-27
K112546	O_two CPAP System	O-Two Medical Technologies, Inc.	BYE	Class II	2011-12-27
K112387	Procedure Rehearsal Studio(tm)	Simbionix, Ltd.	LLZ	Class II	2011-12-27
K113443	21.3 Inch (54 Cm) Monochrome Lcd Monitor Ms23i2 (Ml21023)	Totoku Electric Co., Ltd.	LLZ	Class II	2011-12-23
K113109	Stryker Resorbable Fixation System	Stryker Corp.	HRS	Class II	2011-12-23
K112901	Eme Self Monitoring Blood Glucose System, Eme Pro Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	LFR	Class II	2011-12-23
K112799	Med-Rx Extension Set with T-Connector	Canadian Hospital Specialties Ltd.	FPA	Class II	2011-12-23
K112789	Easy Touch	MHC Medical Products	FMI	Class II	2011-12-23
K112664	Zavation Ibf Systems	Zavation	ODP	Class II	2011-12-23
K112567	Biomerix Assure	Biomerix Corporation	FTL	Class II	2011-12-23
K112499	Biomerix Composite Surgical Mesh	Biomerix Corporation	FTL	Class II	2011-12-23
K112412	Au5800(r) Chemistry Analyzer	Siemens Healthcare Diagnostics Inc.	CEM	Class II	2011-12-23
K112352	Glucose Meter-Check Control for Nipro Trueresult	Bionostics, Inc.	JJX	Class I	2011-12-23
K111680	Dr. Greensburg's Hybrid	Always More Marketing Inc	LRK	Class II	2011-12-23
K111673	1.5T and 3T 8-Channel Medium General Purpose Flex Coil	Invivo Corporation	MOS	Class II	2011-12-23
K110726	Roche Acetaminophen Assay	Roche Diagnostics GmbH	LDP	Class II	2011-12-23
K110717	Konica Minolta Xpress Digital Mammography System	Konica Minolta Medical & Graphic, Inc.	MUE	Class II	2011-12-23
K110313	Tina-Quant Hba1c Gen.2	Roche Diagnostics GmbH	LCP	Class II	2011-12-23
K113591	Cols Peek	Fournitures Hospitalieres Industrie	HWC	Class II	2011-12-22
K113244	Synapse Mpr Fusion	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-12-22
K113140	Vari-Lase Wirefiber Laser Fiber	Vascular Solutions LLC	GEX	Class II	2011-12-22
K112907	Confidence High Viscosity Spinal Cement, 16G / 20G	Medos International SARL	NDN	Class II	2011-12-22
K112783	Manujet III	VBM Medizintechnik GmbH	BTL	Class II	2011-12-22
K112776	Tomotherapy Treatment System Fast Optimizer	Accuray Incorporated	MUJ	Class II	2011-12-22
K112515	Pencan Spinal Needle	B.Braun Medical, Inc.	BSP	Class II	2011-12-22
K112423	Collagen Tendon Sheet	Rotation Medical, Inc.	FTM	Class II	2011-12-22
K112216	U-Right Td-3128 Blood Pressure Monitoring System	Taidoc Technology Corporation	DXN	Class II	2011-12-22
K112172	Quidel Molecular Influenza a + B Assay	Ortho-Clinical Diagnostics, Inc.	OCC	Class II	2011-12-22
K112109	The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection Device	Wenzel Spine	LLZ	Class II	2011-12-22
K112041	Koo Small Volume Nebulizer (Svn)	Koo (Shanghai) Industries Co., Ltd	CAF	Class II	2011-12-22
K111919	Immunocap Specific Ige Allergen Bundle, 12 Allergen Components	Phadia AB	DHB	Class II	2011-12-22
K111617	Pulse Oximeter Model Ab-F1/ah-S1/ah-M1	Acare Technology Co., Ltd.	DQA	Class II	2011-12-22
K111324	Cr Mammography System with Dx-M Digitizer	AGFA Healthcare Corp.	MUE	Class II	2011-12-22
K111211	Cell-Dyn 22 Plus Control	Streck LLC	GLQ	Class II	2011-12-22
K111204	Cell-Dyn 22 Plus Calibrator	Streck LLC	KRX	Class II	2011-12-22
K111159	Heartcheck Pen Handheld ECG with Gems Home	Cardiocomm Solutions, Inc.	DPS	Class II	2011-12-22
K110798	Senographe Ds, Senographe Essential	General Electric Co.	MUE	Class II	2011-12-22
K110381	Cell-Dyn Emerald 22 System	Abbott Medical	GKZ	Class II	2011-12-22
K110198	Blue Sky Bio Tcp	Blue Sky Bio, LLC	LYC	Class II	2011-12-22
K113563	N-Hybride-Composite Lc	Voco GmbH	EBF	Class II	2011-12-21
K113493	Tcx-I Remote Care Management System	Bl Healthcare, Inc.	DRG	Class II	2011-12-21
K113479	Optimedica Catalys Precision Laser System	OptiMedica Corp.	OOE	Class II	2011-12-21
K113444	N-Hybride-Composite Lc Flow	Voco GmbH	EBF	Class II	2011-12-21
K113427	Fresenius 2008T Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2011-12-21
K113251	Synthes Matrixmandible Performed Reconstruction Plates	Synthes GmbH	JEY	Class II	2011-12-21
K113176	Mysense Heart	ZOLL Medical Corporation	DSH	Class II	2011-12-21
K113075	Embryo Viewer Software	Unisense Fertilitech A/S	MQG	Class II	2011-12-21
K113044	Synthes Mirs	Synthes GmbH	NKB	Class II	2011-12-21
K112920	Range Spinal System (Mesa and Denali)	K2M, Inc	MNI	Class II	2011-12-21