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 1041 of 3531

510(k) clearances, page 1041 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K082275	Clover A1c/glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023	Infopia Co, Ltd.	LCP	Class II	2010-01-14
K093866	Evalve Steerable Guide Catheter	Evalve, Inc.	DRA	Class II	2010-01-13
K093832	Levitronix Centrimag Primary and Backup Consoles	Levitronix, LLC	DWA	Class II	2010-01-13
K093825	Ambu Neuroline Disposable Inoject Needle Electrode	Ambu A/S	IKT	Class II	2010-01-13
K092942	Vital Sleep	The Snore Reliever Company	LRK	Class II	2010-01-13
K092890	Asthma Monitor Am3	Carefusion Germany 234 GmbH	BZG	Class II	2010-01-13
K092811	Fully Automatic Electronic Blood Pressure Monitor, Models Kd-7035B, Kd-7921, Kd-7903	Andon Health Co., Ltd	DXN	Class II	2010-01-13
K092583	Soprolife	Sopro	NBL	Class II	2010-01-13
K092118	Angiographic Catheter, Model Angios	Oscor Inc.	DQO	Class II	2010-01-13
K093925	Lifenet System	Physio Control, Inc.	MSX	Class II	2010-01-12
K093596	Lumos, Model R 72B	Lumos, Inc.	KPW	Class II	2010-01-12
K092864	Aespire 7900, Aespire View	Datex-Ohmeda Inc., A Division of Instrumentarium C	BSZ	Class II	2010-01-12
K092739	Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light Source Sterile	C-Link Micro Imaging, Inc.	ODF	Class II	2010-01-12
K093588	Explorer 4D Treatment Planning System	American Radiosurgery, Inc.	MUJ	Class II	2010-01-11
K093360	Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5t-3.5F/4.5t	Exactech, Inc.	JWH	Class II	2010-01-11
K092909	Synthes 7.3 Mm Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe)	Synthes (USA) Products LLC	HWC	Class II	2010-01-11
K092479	Sdx-Spirodynr'x Radiotherapy Breathing Control	Dyn'R	IYE	Class II	2010-01-11
K093982	Xeleris 3 Processing and Review Workstation	GE Medical Systems F.I. Haifa	LLZ	Class II	2010-01-08
K093807	Hardydisk Ast Telavancin,30ug	Hardy Diagnostics	JTN	Class II	2010-01-08
K093469	Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple, Prefix C-Ptbs	Cook Inc.	JOH	Class II	2010-01-08
K093355	PCR Eleva 1.2	Philips North America LLC	LLZ	Class II	2010-01-08
K093013	Blood Pressure Monitor, Model Md200a	Beijing Choice Electronic Technololgy Co., Ltd.	DXN	Class II	2010-01-08
K093008	Halo Ablation Catheter, Model 90-9100	Barrx Medical, Incorporated	GEI	Class II	2010-01-08
K092827	Dimela Obsterical Forceps, Model 72.1 Xx Xx	Dimeda Instrumente GmbH	HDA	Class II	2010-01-08
K092652	Fingertip Pulse Oximeter, Model Md300ca Nd300ca	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2010-01-08
K092330	Oc-Sensor Diana Ifob Test	Polymedco Cancer Diagnostics, LLC	OOX	Class II	2010-01-08
K091954	Micro-Stick Set	Medcomp	DYB	Class II	2010-01-08
K091506	Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520	R4 Vascular, Inc.	MSD	Class II	2010-01-08
K090467	Digital X-Ray Imaging System, Model Pax-Uni3d	Vatech Co., Ltd.	OAS	Class II	2010-01-08
K090401	Orthoss	Ed. Geistlich Soehne AG Fur Chemische Industrie	MQV	Class II	2010-01-08
K090025	Matrix RF Applicator	Syneron Medical, Ltd.	GEI	Class II	2010-01-08
K082097	Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture	Demetech Corp.	NEW	Class II	2010-01-08
K093817	Gelweave Branched Vascular Grafts with Radiopaque Markers	Vascutek, Ltd.	DSY	Class II	2010-01-07
K093809	Vidar Dental Film Digitizer	Vidar Systems Corp.	LMA	Class II	2010-01-07
K093550	Mini Rail External Fixator System	Small Bone Innovations, Inc.	KTT	Class II	2010-01-07
K093502	Vari-Lase Endovenous Laser Console	Vascular Solutions LLC	GEX	Class II	2010-01-07
K093349	Medline Curad Wound Dressings	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2010-01-07
K092900	Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem	Exactech, Inc.	PHX	Class II	2010-01-07
K092833	Endomax Cordless Endodontic Handpiece	Dentamerica	EKX	Class I	2010-01-07
K092780	Inf 4160 Plus, Model D-Fj31f	FUJI Dynamics Limited	LIH	Class II	2010-01-07
K092636	Pogs, Model 65/130	On Site Gas Systems Inc.	CAW	Class II	2010-01-07
K092447	Digital Thermometer (with Disposable Thermometer Cover), Dt Series	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2010-01-07
K092346	Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171	Serim Research Corp.	JOJ	Class II	2010-01-07
K091994	Mountaineer Laminoplasty System	DePuy Spine, Inc.	NQW	Class II	2010-01-07
K091182	Champions Implants Gmbh Mimi 1-Piece Precision Implant, Model 1000 Up to 6000	Champions Implants GmbH	DZE	Class II	2010-01-07
K090637	Cardio-Wrap	MAST Biosurgery USA, Inc	DXZ	Class II	2010-01-07
K090345	Mendasil Twg Gel Antimicrobial Skin and Wound Gel	Conseal International, Inc.	FRO	Unclassified	2010-01-07
K093503	Intrax Film Processor	Velopex International, Inc.	IXW	Class II	2010-01-06
K092925	3D Asl	GE Healthcare	LNH	Class II	2010-01-06
K092923	Cytori Puregraft 250/Pure System	Cytori Therapeutics, Inc.	MUU	Class II	2010-01-06