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 2026-11-02, 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 962 of 3531

510(k) clearances, page 962 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102946	Coreleader Colla-Pad Model Cs 03030	Coreleader Biotech Co., Ltd	KGN	Unclassified	2011-05-20
K102740	Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt); Nuclisens Director V.2.6	bioMerieux, Inc.	NQX	Class II	2011-05-20
K102512	Rms Subcutaneous Needle Set	Repro-Med Systems, Inc.	FPA	Class II	2011-05-20
K101090	Easyra Alkaline Phosphatase, Aspartate Aminotransferase and Amylase Reagents	Medica Corp.	CJE	Class II	2011-05-20
K092801	ABS Blower, ABS Nozzle, Model 1001	Nimbic Systems, Inc.	ORC	Class II	2011-05-20
K111039	Zimmer Periarticular Locking Plate System	Zimmer GmbH	HRS	Class II	2011-05-19
K110709	Ark Care Diabetes Managment System	Arkray Factory USA, Inc.	NBW	Class II	2011-05-19
K110533	Stryker Patient Specific Cutting Guide	Stryker Corp.	MBH	Class II	2011-05-19
K110335	Ceramic Brackets	Ortho Organizers Inc	NJM	Class II	2011-05-19
K110302	Adhesive Exl-759	3M Espe AG	KLE	Class II	2011-05-19
K110283	Zenius Spinal System	Medyssey Co., Ltd.	MNI	Class II	2011-05-19
K110230	Rog Knotless Suture Anchor	Rog Sports Medicine, Inc.	MBI	Class II	2011-05-19
K103822	Synthes Hemostatic Bone Putty (Hbp)	Synthes (USA) Products LLC	MTJ	Unclassified	2011-05-19
K103509	Unimax Suction Irrigation Set	Unimax Medical Systems Inc.	GCJ	Class II	2011-05-19
K102993	Elitech Clinical Systems Triglycerides Sl, Elitech Clinical Systems Cholesterol Sl	VitalScientific	CDT	Class I	2011-05-19
K100547	Elitech Clinical Systems Hba1c Reagent, Elitech Clincal System Hba1c Calibrator Set, Elitech Clinical	VitalScientific	LCP	Class II	2011-05-19
K111064	Tigerpaw System II	Laax, Inc.	GDW	Class II	2011-05-18
K110574	Biomet Microfixation Sternalock Blu Sternal Closure System	Biomet Microfixation	HRS	Class II	2011-05-18
K110229	Rog Suture Anchor 5.5Mm, 2.9Mm	Rog Sports Medicine, Inc.	MBI	Class II	2011-05-18
K110006	Ois Symphony Image Managment System	Ophthalmic Imaging Systems	NFJ	Class II	2011-05-18
K103812	Mitra-Lift	Sciencity Co., Ltd.	KRH	Class II	2011-05-18
K103560	Shaser Ipl Hair Removal System	Shaser, Inc.	ONF	Class II	2011-05-18
K103377	Charter Guidewire Model 45-281, 45-282, 45-283	Brivant, Ltd.	DQX	Class II	2011-05-18
K102733	Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor	Cogentix Medical, Inc.	EOB	Class II	2011-05-18
K101946	Vidas Toxo Igg Avidity	bioMerieux, Inc.	LGD	Class II	2011-05-18
K111321	Remote View Software	Cariescan, Ltd.	NBL	Class II	2011-05-17
K111163	Chitogauze Fusion	Hem Con Medical Technologies, Inc.	QSY	Unclassified	2011-05-17
K111001	Sterile Storm (R) Operating Kit	Intelligent Orthopaedics, Ltd.	HWC	Class II	2011-05-17
K110722	Rps Adeno Detector Plus	Rapid Pathogen Screening, Inc.	GOD	Class I	2011-05-17
K110706	Exactech Equinoxe Cuff Tear Arthroplasty (Cta) Head	Exactech, Inc.	KWT	Class II	2011-05-17
K110484	Self Cure Temporary Crown and Bridge Material	Novocol, Inc.	EBG	Class II	2011-05-17
K110188	Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit	Diazyme Laboratories, Inc.	LCP	Class II	2011-05-17
K103765	Mac 600 Resting ECG Analysis System	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2011-05-17
K103094	Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry Monitor	Edwards Lifesciences LLC	DXG	Class II	2011-05-17
K102317	Iq Ventilation Nasal Mask	SleepNet Corporation	BZD	Class II	2011-05-17
K102251	Dash Knee	Brainlab, Inc.	OLO	Class II	2011-05-17
K083423	Coloncad Api 3.1	Medicsight	NWE	Class II	2011-05-17
K111243	Fujinon Ultrasonic Processor	FUJIFILM Healthcare Americas Corporation	FDS	Class II	2011-05-16
K110986	Optomed Smartscope M5 Ey3 and M5 Es1	Optomed	HKI	Class II	2011-05-16
K110510	S20 Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2011-05-16
K110415	Signature Planner / Signature Guides	Materialise N.V.	HRY	Class II	2011-05-16
K110303	Stratus Cs Acute Care D-Dimer	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2011-05-16
K102887	Accordion Stone Management Device Model Ac281205 and Ac3814510	Percutaneous Systems, Inc.	FFL	Class II	2011-05-16
K102535	Etest Telavancin in 0.002-32 Ug/ml and 0.016-256 Ug/ml	bioMerieux, Inc.	JWY	Class II	2011-05-16
K101779	Clearvision Dr 2000 Digital Radiography X-Ray System	JPI Healthcare Co., Ltd	KPR	Class II	2011-05-16
K100130	Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2	Mitsubishi Chemical Medience Corporation	MMI	Class II	2011-05-16
K111257	Heisenberg Dyeing Liquids	3M Espe AG	EIH	Class II	2011-05-13
K111234	Click-It	TP Orthodontics, Inc.	NJM	Class II	2011-05-13
K111227	Aloka Ssd-3500 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2011-05-13
K111121	Vitamesh (Tm) Blue Lightweight Macroporous Pp Surgical Mesh	Proxy Biomedical Ltd.	FTL	Class II	2011-05-13