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 856 of 3530

510(k) clearances, page 856 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123096	Reprocessed Vessel Sealer	Sterilmed Inc	NUJ	Class II	2013-01-25
K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	HRS	Class II	2013-01-25
K123008	Rightest Blood Glucose Monitoring System Gm700 Ge Ge200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin	Bionime Corporation	NBW	Class II	2013-01-25
K122797	Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw	Ethicon Endo-Surgery Inc	GEI	Class II	2013-01-25
K122793	Liaison Testosterone; Liaison Testosterone Control Set	Diasorin Inc.	CDZ	Class I	2013-01-25
K122172	System 83 Plus	Wassenburg Medical B.V.	FEB	Class II	2013-01-25
K122125	Asa Laser Sh1	El.en. Electronic Engineering SpA	ILY	Class II	2013-01-25
K121860	Esa615	Fluke Biomedical	DRT	Class II	2013-01-25
K121670	Medyssey Cannulated Pedicle Screw	Medyssey Co., Ltd.	NKB	Class II	2013-01-25
K121455	Bact/alert Fn Plus Culture Bottle	bioMerieux, Inc.	MDB	Class I	2013-01-25
K121446	Bact/alert Pf Plus Culture Bottle	bioMerieux, Inc.	MDB	Class I	2013-01-25
K121326	Lantos 3D Ear Scanner	Lantos Technologies	ERA	Class I	2013-01-25
K113375	Eswallow USA Electrode,eswallow USA Leadwire	Eswallow USA	GXY	Class II	2013-01-25
K123334	Reprocessed Steerable Introducer	Stryker Sustainability Solutions	DYB	Class II	2013-01-24
K123325	Medafor Direct Gas-Assisted Application System	Medafor, Inc.	GCJ	Class II	2013-01-24
K123304	Sr Nexco Paste Layering Materials, Sr Nexco Opaquer, Sr Nexco Liner-Sr Nexco Connect, Sr Nexco Stains, Sr Nexco Retentio	Ivoclar Vivadent, Inc.	EBF	Class II	2013-01-24
K123071	Vashe Skin and Wound Hydrogel	Puricore, Inc.	FRO	Unclassified	2013-01-24
K122926	Sureflex Steerable Guiding Sheath Kit	Baylis Medical Co., Inc.	DYB	Class II	2013-01-24
K122251	Vitra Multispot	Quantel Medical	GEX	Class II	2013-01-24
K121800	Point 500 Hd Point500c Hd	Pointnix Co., Ltd.	MUH	Class II	2013-01-24
K112120	Diazyme D-Dimer Assay Kit,calibrator Setand Control Set	Diazyme Laboratories, Inc.	GHH	Class II	2013-01-24
K123982	Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+	Encore Medical, LP	KWS	Class II	2013-01-23
K123857	Durablue Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2013-01-23
K123579	Footprint Ultra Pk4.5mm and 5.5Mm Suture Anchor, Sl	Smith & Nephew, Inc.	MBI	Class II	2013-01-23
K123401	Gamma3 and T2 Recon Targeting Devices	Stryker Trauma GmbH	HSB	Class II	2013-01-23
K123310	Finesse 3Rd Generation (Models Finesse+ and Finesseii+)	Utah Medical Products, Inc	GEI	Class II	2013-01-23
K123281	Acculif Tl-Peek Cage	Coalign Innovations, Inc.	MAX	Class II	2013-01-23
K122290	Envitec Mysign O Oxygen Measuring Device	Envitec-Wismar GmbH	CCL	Class II	2013-01-23
K121964	Markit Tissue Marker-1Ml Markit Tissue Marker-3Ml Markit Tissue Marker-10Ml	Augmenix, Inc.	NEU	Class II	2013-01-23
K121810	Osseospeed Angled Abutment Ev	Astra Tech, Inc.	NHA	Class II	2013-01-23
K112728	Hepairx Ventilating Air Purifier	Air Innovations, Inc.	FRF	Class II	2013-01-23
DEN130012	Ferriscan R2-MRI Analysis System	Resonance Health Analysis Services Pty Ltd	PCS	Class II	2013-01-23
K123967	Catheter Connections' Dark Blue Dualcap for Male Luers	Catheter Connections, Inc.	QBP	Class II	2013-01-22
K123718	Permasorb Disposable Fixation Device	C.R. Bard Inc	GDW	Class II	2013-01-22
K123577	Syngo.via Mi Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2013-01-22
K123566	Synapse 3D Colon Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2013-01-22
K123314	Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface	Medtronic, Inc.	DTZ	Class II	2013-01-22
K122995	Intense Pulsed Light (Ipl) Systems	Beijing Kes Biology Technology Co., Ltd.	ONF	Class II	2013-01-22
K121461	Bact/alert Fa Plus Culture Bottle	bioMerieux, Inc.	MDB	Class I	2013-01-22
K121269	Tba	Migada Plant	FPA	Class II	2013-01-22
K123920	Syngo.via	Siemens AG Medical Solutions	LLZ	Class II	2013-01-18
K123828	Prosound F75 Diagnostic Ultrasound System	Hitachi Aloka Medical, Ltd.	IYN	Class II	2013-01-18
K123813	Vascular Positioning System (Vps) G4 Console	Teleflex Medical	OBJ	Class II	2013-01-18
K123328	Powder Free Nitrile Examination Gloves, Blue and Black	Nitrilist Gloves Manufacturing Sdn Bhd	LZA	Class I	2013-01-18
K123300	Bd Pen Needle	Becton Dickinson & Co	FMI	Class II	2013-01-18
K123299	Mts System, Wide-Space Quattrode Percutaneous Leads	St. Jude Medical Neuromodulation	GZB	Class II	2013-01-18
K123231	Caliber Spacers	Globus Medical, Inc.	MAX	Class II	2013-01-18
K123163	Neuropace Burr Hole Cover Model 8110	Neuropace	GXR	Class II	2013-01-18
K123098	Xgeo Gc80	Samsung Electronics Co., Ltd.	KPR	Class II	2013-01-18
K122768	Genesis	Dornier Medtech America, Inc.	JAA	Class II	2013-01-18