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 1451 of 3531

510(k) clearances, page 1451 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030973	Picosat II Spo2 Pulse Oximetry Module	Philips North America LLC	DQA	Class II	2003-07-23
K023044	Model 9600, Avant Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2003-07-23
K014074	Hoffrichter Vector, Vector Plus, Vector Bi-Vevel, Vector Bi-Level Plus, Scalar, Scalar Plus; CPAP with Humidifier Option	Hoffrichter GmbH	BZD	Class II	2003-07-23
K032103	Philips Tracemaster ECG Management System, Models M5100a and M5101a	Philips North America LLC	DSH	Class II	2003-07-22
K031424	Ebi Spinelink Spinal Fixation System	Ebi, LLC	NKB	Class II	2003-07-22
K031355	Ebi Spinelink - II Spinal Fixation System	Ebi, LLC	NKB	Class II	2003-07-22
K031161	Variable Lasso 2515 Circular Mapping Catheter	Biosense Webster Inc	DRF	Class II	2003-07-22
K030637	Ekos Peripheral Infusion System	Ekos Corp.	QEY	Class II	2003-07-22
K032135	Site-Rite IV Ultrasound System	Dymax Corp	IYO	Class II	2003-07-21
K032133	Broda Model 587 Manual Wheelchair	Broda Ent., Inc.	IOR	Class I	2003-07-21
K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2003-07-21
K031978	Amplaid A756 Screening Admittance Meter	Amplaid	ETY	Class II	2003-07-21
K031912	Bd Phoenix Automated Micrbiology System Amoxicillin/clavualante 0.5/0.25-32/16 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-07-21
K031847	Cardiovations Retractor	Ethicon, Inc	GCJ	Class II	2003-07-21
K031846	Cardiovations Optical Bipolar Device	Ethicon, Inc	GEI	Class II	2003-07-21
K031802	Corix 70 Plus-Usv	Coramex, S.A.	EHD	Class II	2003-07-21
K031638	Cardio Vascular Information Enhanced Workstation	Electromed Imaging, Inc.	LLZ	Class II	2003-07-21
K031615	Sled Curing Light System	Dentsply International, Inc.	EBZ	Class II	2003-07-21
K031597	Dunlee Format Collimator Family	Philips North America LLC	IZW	Class II	2003-07-21
K031249	Modification to Stryker Painpump	Stryker Corp.	FRN	Class II	2003-07-21
K031085	Gyrus Plasmakinetic Superpulse System (Generator, Accessories)	Gyrus ACMI, Inc.	GEI	Class II	2003-07-21
K030926	Fast Throw Stainless Steel Surgical Suture	Advanced Surgical Products, Inc.	FZP	Class II	2003-07-21
K030634	Endos Dc	Villa Sistemi Medicali S.p.A.	EHD	Class II	2003-07-21
K030442	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard Inc	NFK	Class II	2003-07-21
K030392	Sapphire Detachable Coil System	Medtronic, Inc.	HCG	Class II	2003-07-21
K030177	Orlon Nonabsorable Surgical Suture Usp	Sri Orion Pharmaceuticals & Sutures	GAR	Class II	2003-07-21
K030033	Lumenis Family of Disposable Contact Tip Delivery Devices	Lumenis Ltd	GEX	Class II	2003-07-21
K024377	Transcranial Electrotherapy Stimulator-a, Model Tesa-1	Kalaco Scientific, Inc.	QJQ	Class II	2003-07-21
K032111	Acuson Cv70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2003-07-18
K032096	Philips Viewforum 2003	Philips North America LLC	LLZ	Class II	2003-07-18
K031906	Apeel Cs Catheter Delivery System	Abbott Medical	DYB	Class II	2003-07-18
K031894	Scantec Pad	Sonotech, Inc.	MUI	Class II	2003-07-18
K031874	Modification to Wbr, Model Hr	U.C.G. Technologies, Ltd.	KPS	Class II	2003-07-18
K031821	Modification to Cook Zilver Biliary Stent	Cook Inc.	FGE	Class II	2003-07-18
K031631	Stereotactic Body Frame, Model Cod. 70-1A	3D Line USA, Inc.	IYE	Class II	2003-07-18
K031536	Brain Coil, Model 9900Ge-64	Clinical MR Solutions, LLC	MOS	Class II	2003-07-18
K031504	Echo Sounder, Single-Handed, Model Es-101Ex	Koven Technology, Inc.	KNG	Class II	2003-07-18
K031477	Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens	Ocular Sciences	LPL	Class II	2003-07-18
K031365	Prima III Totalsense Torso Coil	GE Healthcare Coils	MOS	Class II	2003-07-18
K031057	Per-Fit Percutaneous Dilational Tracheostomy Kit	Abbott Medical	JOH	Class II	2003-07-18
K030669	Providence Molding Helmet	Northeast Orthotics and Prothetics, Inc.	MVA	Class II	2003-07-18
K030477	Diadexus Plac Test	Diadexus, Inc.	NOE	Class II	2003-07-18
K032129	Radius 018 Cougar Wire	Radius Medical Technologies, Inc.	DQX	Class II	2003-07-17
K032046	Phillips Omnidiagnost Eleva	Philips North America LLC	OWB	Class II	2003-07-17
K031956	Modification to Hermes o.r. Control Center	Computer Motion, Inc.	GCJ	Class II	2003-07-17
K031950	Baylis Pain Management Generator, Models Pmg-115-Td and Pmg-230-Td	Baylis Medical Co., Inc.	GEI	Class II	2003-07-17
K031926	Rita Model 1500X Electrosurgical RF Generator and Accessories (E.g., Rita Thermo Pad and Cable Adapter)	Boston Scientific Corporation	GEI	Class II	2003-07-17
K031916	Galt Medical Guidewire	Galt Medical Corp	DQX	Class II	2003-07-17
K031893	Xia Spinal System and Xia Stainless Steel System	Howmedica Osteonics Corp	KWP	Class II	2003-07-17
K031879	Cobas Integra Carbon Dioxide Assay	Roche Diagnostics GmbH	KHS	Class II	2003-07-17