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 1013 of 3531

510(k) clearances, page 1013 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101252	Neotract Anchor System Model: Ref 11208	Neotract Inc	GAT	Class II	2010-07-15
K101140	Dentlight Oral Exam Light Kit	Dentlight Inc.	NXV	Class II	2010-07-15
K101109	Vivatrak	Wireless Medcare, LLC	KMI	Class I	2010-07-15
K100762	Flat Panel Detector, Model Fdr D-Evo	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2010-07-15
K100644	Optos Limited Panoramic 200Caf	Optos PLC.	MYC	Class II	2010-07-15
K100481	Smith & Nephew Mdf Modular Sleeve	Smith & Nephew, Inc.	MEH	Class II	2010-07-15
K100441	Xiniwave, Model Xw-18	International Trade Group, Inc.	NUH	Class II	2010-07-15
K100109	Logiflex Laparoscopic Band Positioning Device	Surgical Innovations Ltd	GCJ	Class II	2010-07-15
K100066	Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1	Welldoc	MRZ	Class II	2010-07-15
K093903	Ats Tri-Ad Semi-Flexible Tricuspid Anuuloplasty, Model 900Sfc	Genesee BioMedical, Inc.	KRH	Class II	2010-07-15
K093775	Evguide Tip Location System	Romedex International SRL	LJS	Class II	2010-07-15
K093497	Thd Bandy	Thd SpA	FHN	Class II	2010-07-15
K093024	Yeast Traffic Light Pna Fish	Advandx, Inc.	NZS	Class I	2010-07-15
K092819	Remel Spectra Vre	Thermo Fisher Scientific Oy	JSO	Class II	2010-07-15
K101858	Pediatric Head-Spine Coil (Model:5000012701	Shanghai Chenguang Medical Technologies Co, Ltd	MOS	Class II	2010-07-14
K101735	Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-Xxyy	Spectranetics Corp.	PNO	Class II	2010-07-14
K101328	Ensite Velocity System	Abbott Medical	DQK	Class II	2010-07-14
K101053	Olympus Cf Type Y0023-L, Y0023i	Olympus Medical Systems Corp.	FDF	Class II	2010-07-14
K100876	Aesculap Monomax Absorbable Suture	Aesculap Inc	NWJ	Class II	2010-07-14
K100038	Disposable Reflective Marker Spheres	Brainlab, Inc.	HAW	Class II	2010-07-14
K093648	Simplisse Electric Breastfeeding Companion	Simplisse, Inc.	HGX	Class II	2010-07-14
K093179	Medical Surgical Mask (Hh1001), Respiratory Mask (Hh1002)	H & H Research, Inc.	FXX	Class II	2010-07-14
K101703	Modification to: Cg-6108 Act-3L Continuous ECG Monitor and Arrhythmia Detector, Model Fg-00084	Card Guard Scientific Survival, Ltd.	DSI	Class II	2010-07-13
K101570	Hyperglide and Hyperform Occlusion Balloon Systems	Micro Therapeutics dba Ev3 Neurovascular	MJN	Class II	2010-07-13
K101047	Pta-Duo Pta Balloon Catheter	Hotspur Technologies	LIT	Class II	2010-07-13
K100950	Venner Pneux P.y. (Tm) Tracheostomy Tube	Venner Medical (Singapore) Pte Ltd	BTO	Class II	2010-07-13
K100890	Varian High Energy Linear Accelerator	Varian Medical Systems, Inc.	IYE	Class II	2010-07-13
K100826	Penumbra Catherer 025	Penumbra Inc.	DQY	Class II	2010-07-13
K100360	Bia300 Series Implant and Abutment, Bi300 Implant, Ba300 Abutment	Cochlear Americas	LXB	Class II	2010-07-13
K100121	Model 300157 CPAP System	Aeiomed, Inc.	BZD	Class II	2010-07-13
K093262	Ag-608 Blood Glucose Monitoring System and Ag-610 Blood Glucose Monitoring System	Andon Medical co., Ltd	NBW	Class II	2010-07-13
K101411	Savi Preparation Device	Cianna Medical, Inc.	JAQ	Class II	2010-07-12
K101059	Omega Laboratories Hair Drug Screening Assay for Phencyclidine	Omega Laboratories, Inc.	LCM	Unclassified	2010-07-12
K100925	Ascension Ankle Fusion Nail System	Ascension Orthopedics, Inc.	HSB	Class II	2010-07-12
K100842	Pta-Plus Pta Balloon Cather 5 Mm X 4Cm, Pta-Plus Pta Balloon Catheter 6Mm X 4Cm	Hotspur Technologies	DXE	Class II	2010-07-12
K100840	Embo Plus Embolectomy Catheter	Hotspur Technologies	DXE	Class II	2010-07-12
K093967	Varian Treatment	Varian Medical Systems, Inc.	IYE	Class II	2010-07-12
K093910	Improvacuter Gel & Clot Activator Tube	Guangzhou Improve Medical Instruments Co., Ltd.	JKA	Class II	2010-07-12
K101680	Welch Allyn Spot Vital Signs Lxi Model 45000 Series	Welch Allyn Inc	DXN	Class II	2010-07-09
K101651	Angioguard Xp Emboli Capture Guidewire, Angioguard Rx Emboli Capture Guidewire	Cordis US Corp.	NTE	Class II	2010-07-09
K101629	Fil 1520	Glenn Medical Systems, Inc.	CAH	Class II	2010-07-09
K101514	Bd Directigen Ez Rsv	Becton Dickinson & Co	GQG	Class I	2010-07-09
K101460	Loci 8 Calibrator, Model Kc 646	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2010-07-09
K101022	Pulmotrack 5050 Wholter, Model 5050	Karmelsonix	DSH	Class II	2010-07-09
K100956	Spondy Spinal Fixation System	Allure Spine LLC	MNH	Class II	2010-07-09
K100907	Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White: X-Small, Small	Siam Sempermed Corp., Ltd.	LYY	Class I	2010-07-09
K100818	Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920	Meridian Bioscience Inc	OMN	Class I	2010-07-09
K100740	Md2000b Vital Sign Monitor, Model Md2000b	Beijing Choice Electronic Technololgy Co., Ltd.	MWI	Class II	2010-07-09
K100732	Fora G30a Blood Glucose Monitoring System, Model Td-4241	Taidoc Technology Corporation	NBW	Class II	2010-07-09
K100658	U-Right Td-3127 Blood Pressure Monitoring System	Taidoc Technology Corporation	DXN	Class II	2010-07-09