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 1286 of 3531

510(k) clearances, page 1286 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K053153	Randox Calibration Serum	Randox Laboratories, Limited	JIX	Class II	2006-01-13
K053110	Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge	I-Stat Corp.	JGS	Class II	2006-01-13
K053004	Msas-Vantage	Biomeridian, Int.	GZO	Class II	2006-01-13
K052976	Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories	GE Healthcare	DQK	Class II	2006-01-13
K052935	Heidelberg Engineering Slitlamp-Oct (Sl-Oct)	Heidelberg Engineering GmbH	MXK	Class II	2006-01-13
K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	NEY	Class II	2006-01-13
K052741	Implantmed Si-915 (115V Version); Implantmed Si-923 (230V Version) Incl. Accessories	W & H DentalWerk Buermoos GmbH	EBW	Class I	2006-01-13
K052723	Seven Star Needle	Helio Medical Supplies, Inc.	MQX	Class II	2006-01-13
K052710	Vita Vm7, Model Nx77 Xxxx, Nx78xxxx, Nx79 Xxxx; Vita Vm 8, Model Vx60 Xxxx, Vx61 Xxxx, Vx62 Xxxx; Vita Vm 9,	Vident	EIH	Class II	2006-01-13
K052453	Traction System, Digit-Trac 930	Ever Prosperous Instrument, Inc.	ITH	Class II	2006-01-13
K052423	Magnetom Systems with Syngo Expert - I Option	Siemens Medi Cal Solutions, Inc.	LNH	Class II	2006-01-13
K052295	Cardiosoft Pc ECG, Usb Version	Cardiosoft, L.P.	DPS	Class II	2006-01-13
K050384	Kapp Bari-Ring, Model Ks-Br-2005	Kapp Surgical GmbH	NEU	Class II	2006-01-13
K042829	Dbx Strip	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MBP	Class II	2006-01-13
K053283	Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set	Pajunk GmbH Medizintechnologie	CAZ	Class II	2006-01-12
K053221	Cdmx-H	Camsight Co., Inc.	MUH	Class II	2006-01-12
K053174	Loflo C5 CO2 Sensor	Respironics Novametrix, LLC.	CCK	Class II	2006-01-12
K053049	Alaris Safety Male Luer	Cardinal Health, Alaris Products	FPA	Class II	2006-01-12
K052920	Delta4	Scandidos, Inc.	IYE	Class II	2006-01-12
K052176	Flowhandy Zan100 Usb	Zan Messgerate GmbH	BZG	Class II	2006-01-12
K053472	Hoffmann II MRI External Fixation System	Howmedica Osteonics Corp	KTT	Class II	2006-01-11
K053130	Onyx II Finger Pulse Oximeter, Model 9550	Nonin Medical, Inc	DQA	Class II	2006-01-11
K052984	Powdered Vinyl Examination Glove	Tg Medical (China) Incorporation	LYZ	Class I	2006-01-11
K052970	Simplici-T Annuloplasty System	Medtronic Heart Valves	KRH	Class II	2006-01-11
K052459	6248Val Adjustable Valve	Medtronic, Inc.	DTL	Class II	2006-01-11
K053522	Philips Mp40, Mp50, Mp60, Mp70, Mp80 and Mp90 Intellivue Patient Monitors, Release D.00	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2006-01-10
K053502	Newport E360 Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2006-01-10
K053232	Precision Blender	Precision Medical, Inc.	BZR	Class II	2006-01-10
K053106	Tego, Model D1000	Abbott Medical	FPA	Class II	2006-01-10
K052369	Exfeel Implant System	Megagen Co., Ltd.	DZE	Class II	2006-01-10
K051271	Oximax Neomax Adhesive Forehead Reflectance Oximetry Sensor	Medtronic, Inc.	DQA	Class II	2006-01-10
K053425	Precision Optics Corporation Video Ophthalmoscope, Model 2500-Vos	Precision Optics Corp.	HLJ	Class II	2006-01-09
K052820	Parapost Paracore Automix 5Ml	Coltene /Whaledent AG	EBF	Class II	2006-01-09
K052556	Cg-7000Dx-Bt ECG Recorder/transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	2006-01-09
K053474	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2006-01-06
K053445	Smartmix Cemvac Pre-Filled with Smartset Hv Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2006-01-06
K053437	Ekos Micro-Infusion System	Ekos Corp.	NUI	Class II	2006-01-06
K053410	Gientriport with Universal Single Lumen Adaptor	Kendall	FEG	Class II	2006-01-06
K053326	Estech Cobra Electrosurgical Unit & Cable	Endoscopic Technologies, Inc.	GEI	Class II	2006-01-06
K053322	Modification to: Roei Working Element and Roei Cutting Loops	Roei Medical Technologies, Ltd.	FAS	Class II	2006-01-06
K053242	Pitt-Easy Dental Implant System	Innova Life Sciences Corp.	DZE	Class II	2006-01-06
K053220	Veraview Ic 5, Model Xdp1	J. Morita USA, Inc.	MUH	Class II	2006-01-06
K053210	Mayfield Scanmate Mobile CT System	Schaerer Mayfield USA, Inc.	JAK	Class II	2006-01-06
K053062	Cardiarc Spect Imaging Device, Model Cq103-Rv2	Cardiarc, Ltd.	KPS	Class II	2006-01-06
K053029	Ndr+/diva-D	Nical SpA	MQB	Class II	2006-01-06
K052964	Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven	Boston Scientific Corporation	DSY	Class II	2006-01-06
K052863	Raphael Color	Hamilton Medical AG	CBK	Class II	2006-01-06
K052682	Alignrt	Vision Rt Inc	IYE	Class II	2006-01-06
K052619	The Finger Guard	T F & G Products	DQA	Class II	2006-01-06
K052566	Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-Link Spinal Fixation Sy	Spinal Concepts, Inc.	MNI	Class II	2006-01-06