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 957 of 3531

510(k) clearances, page 957 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100716	Audit Microcv D-Dimer Linearity Set, Model K717m-5	Aalto Scientific Ltd.	GGN	Class II	2011-06-23
K111444	Universal and Troch Entry Femoral Nailing Systems Line Extension	Depuy Orthopaedics Inc.	HSB	Class II	2011-06-22
K111394	Microscan Microstep	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2011-06-22
K111184	Apex Ps Knee System - Ps-C Insert	Omni Life Science, Inc.	JWH	Class II	2011-06-22
K111138	The Picc Wand (R) Peelable Safety Introducer	Access Scientific, Inc.	DYB	Class II	2011-06-22
K111073	Surgivision Inc. Clearpoint System	Surgi-Vision, Inc.	ORR	Class II	2011-06-22
K110907	Palomar Icon (Tm) Aesthetic System	Palomar Medical Technologies, Inc.	GEX	Class II	2011-06-22
K110843	Aleutian Spacer System	K2M, Inc	MAX	Class II	2011-06-22
K110647	Renasys Foam Npwt Wound Dressing Kits with Suction Pad; Renasys Gauze Npwt Wound Dressing Kits with Suction Pad; Renasys	Smith & Nephew, Inc.	OMP	Class II	2011-06-22
K103456	The Sensititre Aim	Trek Diagnostic Systems, Ltd.	LIE	Class II	2011-06-22
K102954	Cutera Qswitch Laser System	Cutera Inc	GEX	Class II	2011-06-22
K102942	Coreleader Algiplaster Model Ap 050501	Coreleader Biotech Co., Ltd	FRO	Unclassified	2011-06-22
K110946	Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle	Galil Medical Ltd.	GEH	Class II	2011-06-21
K110831	Soundbite Hearing System by Sonitus Medical	Sonitus Medical, Inc.	LXB	Class II	2011-06-21
K110830	Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech	ELITechGroup Inc	CIX	Class II	2011-06-21
K110812	CT-Guide Needle Guidance System	Activiews, Ltd.	JAK	Class II	2011-06-21
K110810	Anascient Breath Monitor	Invoy Technologies, LLC	BZL	Class II	2011-06-21
K110805	Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)	Orthofix SRL	OBT	Class II	2011-06-21
K110414	Qlab 8.1 Quantification Software	Philips North America LLC	LLZ	Class II	2011-06-21
K103698	Tenscare Itouch Sure Model Its	Tenscare Ltd.	KPI	Class II	2011-06-21
K102345	Easymax T1 Self Monitoring Blood Glucose System, Model Eps10042	Eps Bio Technology Corp.	NBW	Class II	2011-06-21
K101005	Astra Tech Implant System, New Component	Astra Tech, Inc.	NHA	Class II	2011-06-21
K111410	Nuvasive Long Lateral Spinal System	NuVasive Inc	KWQ	Class II	2011-06-20
K110983	Centrimag Drainage Cannula Kit	Levitronix, LLC	DWF	Class II	2011-06-20
K110980	Centrimag Return Cannula Kit	Levitronix, LLC	DWF	Class II	2011-06-20
K110889	Ind One Step Hcg Urine Pregnancy Test (Strip)	Ind Diagnostics, Inc.	LCX	Class II	2011-06-20
K110509	Everyway Interferntial Stimulator, Model If-908	Everyway Medical Instruments Co., Ltd.	LIH	Class II	2011-06-20
K110402	Biodesign Nipple Reconstruction Cylinder	Cook Biotech, Inc.	FTM	Class II	2011-06-20
K103061	Biomate Sterile Acupuncture Needle	Biomate Medical Devices Technology Co., Ltd.	MQX	Class II	2011-06-20
K111131	Teca (Tm) Elite Disposable Monopolar Needles	Medtronic, Inc.	IKT	Class II	2011-06-17
K111086	Orthopediatrics Fracture and Osteotomy Bone Plate System	Orthopediatrics Corp	HRS	Class II	2011-06-17
K110871	Fit Checker Advanced	GC America Inc.	ELW	Class II	2011-06-17
K110823	Prismaflex	Gambro Renal Products	KDI	Class II	2011-06-17
K110625	Safetymate Talking First Aid	Safetymate, Inc.	OVR	Class I	2011-06-17
K110291	Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device	Smart Medical Systems Ltd.	ODC	Class II	2011-06-17
K110194	Medline Epidural and Spinal Needles	MEDLINE INDUSTRIES, LP - Northfield	BSP	Class II	2011-06-17
K102917	Fixtemp C&b	Exacta Dental Direct, Inc.	EBG	Class II	2011-06-17
K111564	Maxfire Marxmen Meniscal Repair Device	Biomet Sports Medicine	MBI	Class II	2011-06-16
K111459	Powder Free Vinyl Patient Examination Gloves, Light Yellow Color	Jiangsu Alfa Glove Co., Ltd.	LYZ	Class I	2011-06-16
K111297	Synthetic Vinyl Examination Gloves, Powder Free (and Multiple Labels)	Premier Medical Gloves Factory	LYZ	Class I	2011-06-16
K111100	Encor Enspire Breast Biopsy System	C.R. Bard Inc	KNW	Class II	2011-06-16
K110947	Apex K1 Hip Stem	Omni Life Science, Inc.	LPH	Class II	2011-06-16
K110636	Tula Iontophoresis System	Acclarent Inc	EGJ	Class II	2011-06-16
K103783	Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric	Fiab SpA	LDD	Class II	2011-06-16
K103713	Elta Wound Cleanser	Swiss American Products, Inc.	FRO	Unclassified	2011-06-16
K103641	Guardacare	Hem Con Medical Technologies, Inc.	QSY	Unclassified	2011-06-16
K103476	Brivoxr285amx, Optima Xr200amx, Optimaxr220amx	GE Healthcare	IZL	Class II	2011-06-16
K101641	Ag Thermographic Camera, Model Atir-M301	Ag Digital Technology Corp.	LHQ	Class I	2011-06-16
K111307	Azur Detachable 35 Platinum Coil System	Terumo Cardiovascular Systems Corporation	KRD	Class II	2011-06-15
K111237	Md301c4 29.8 Diagnostic Imaging Lcd Monitor, L309ty	Nec Display Solutions, Ltd.	LLZ	Class II	2011-06-15