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 1271 of 3531

510(k) clearances, page 1271 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060959	Symmetry Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2006-04-12
K060798	Stryker Plating System	Howmedica Osteonics Corp	HRS	Class II	2006-04-12
K060782	Versajet Hydrosurgery System and Handpiece	Smith & Nephew Wound Management	FQH	Class II	2006-04-12
K060729	Full Automatic (Nibp) Blood Pressure Monitor, Model Hl168fv	Health & Life Corporation	DXN	Class II	2006-04-12
K060618	Cidex Activated Dialdehyde Solution	Johnson & Johnson	MED	Class II	2006-04-12
K060470	Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080	Medrad, Inc.	NBW	Class II	2006-04-12
K060444	Bd Phoenix Automated Microbiology System - Cefepime (Gn) , Ceftriaxone (Gn), Cefotaxime (Gn), 0.5-64 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-04-12
K060327	Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter	Vascular Solutions LLC	DQY	Class II	2006-04-12
K060225	Nuvasive Spherx System	NuVasive Inc	MNH	Class II	2006-04-12
K060223	Infinity Multiview Infinity Telemetry System	Draeger Medical Systems, Inc.	MHX	Class II	2006-04-12
K060217	Bd Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 - 4 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-04-12
K060119	Mckinley Saturation Catheter	Mckinley Medical, LLC	FRN	Class II	2006-04-12
K060039	Infinity Delta and Kappa Series Monitors with Vf6 Modifications	Draeger Medical Systems, Inc.	MHX	Class II	2006-04-12
K053459	Omnilink .035 Biliary Stent System	Boston Scientific Corporation	FGE	Class II	2006-04-12
K052641	Modification to: Quantum Vertebral Body Replacement	Quantum Orthopedics, Inc.	MQP	Class II	2006-04-12
K052527	Neuroprobes	Alpha Omega Engineering Ltd.	GZL	Class II	2006-04-12
K052243	Proact with Gel or Proact 1	Proact, Ltd.	JOW	Class II	2006-04-12
K060697	Travel Pal (Mm-111B) /Mega Motion	Mega Motion, Inc.	INI	Class II	2006-04-11
K060695	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	LHN	Class II	2006-04-11
K060680	Atrilaze Surgical Ablation System	Medical Cv, Inc.	GEX	Class II	2006-04-11
K060626	Vumax	Sonomed, Inc.	IYO	Class II	2006-04-11
K060532	Hdr 1000 Plus Well Chamber, Model 90008	Standard Imaging Inc.	JAQ	Class II	2006-04-11
K060522	Scandius Tritis Absorbable Tibial Reconstruction System	Scandius Biomedical, Inc.	MAI	Class II	2006-04-11
K060302	Inscope Precision Balloon Dilator - Wire Guided	Cordis Europa, N.V.	KNQ	Class II	2006-04-11
K053520	Ventana Image Analysis System, Model Ki-67	Becton Dickinson & Co	NQN	Class II	2006-04-11
K052643	Epiceram	Ceragenix Corporation	FRO	Unclassified	2006-04-11
K060837	In-Ovation C	Dentsply International, Inc.	NJM	Class II	2006-04-10
K060823	Arthrocare Wands	ArthroCare Corporation	GEI	Class II	2006-04-10
K060755	Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck	Roche Diagnostics GmbH	CDD	Class II	2006-04-10
K060658	Brightway Brand Latex Examination Gloves (Powder Free, Black Color)	Brightway Holdings Sdn. Bhd.	LYY	Class I	2006-04-10
K060410	Echoheart Transvaginal Doppler Probe	Summit Doppler Systems, Inc.	HEK	Class II	2006-04-10
K060391	Intuitive Surgical Endowrist Stabilizer, Model 420182	Intuitive Surgical, Inc.	NAY	Class II	2006-04-10
K060282	Total Knee Surgetics Navigation System	Praxim S.A	HAW	Class II	2006-04-10
K060270	Micropower Hand Piece: Oral Max High Speed Drill	Linvatec Corporation	DZI	Class II	2006-04-10
K060260	Micropower Hand Piece High Speed Drill	Linvatec Corporation	HBC	Class II	2006-04-10
K060193	Magellan-2200 Model -2 Anesthesia Machine, Model 2	Oceanic Medical Products, Inc.	BSZ	Class II	2006-04-10
K060064	Stethoflux	Odvi	JAF	Class II	2006-04-10
K053542	Surgetics Ortho Osteologics Navigation System	Praxim S.A	HAW	Class II	2006-04-10
K053441	Biogel Latex Powder Free Sterile Surgeon's Glove	Regent Medical Americas, LLC	KGO	Class I	2006-04-10
K053117	Ez-Ox Plus	Air Liquide Healthcare America	ECX	Class I	2006-04-10
K052322	Bard Collamend Implant, Models 1175101, 1175102, 1175103, 1175104, 1175105	C.R. Bard Inc	FTM	Class II	2006-04-10
K051984	Filterwire Ez (2.25 Mm - 3.5 Mm) Embolic Protection System, Models 20120-190, 20120-300	Boston Scientific Corporation	NFA	Class II	2006-04-10
K050826	Fetal Ultrasound and Tocodynamometer Transducers	Cetro America	HGM	Class II	2006-04-10
K060840	Sview	Mri Cardiac Services, Incorporated	LLZ	Class II	2006-04-07
K060802	Visum LED Surgical Lighting System	STRYKER Communications, Inc.	FSY	Class II	2006-04-07
K060800	Seeker/spark Ultrasound System	Ardent Sound, Inc.	IYO	Class II	2006-04-07
K060797	Naked	Veraxis Int'L, Inc.	HIS	Class II	2006-04-07
K060661	Mactrode 3	GE Medical Systems Information Technologies, Inc.	DRX	Class II	2006-04-07
K060629	Gelport Blunt Tip Trocar System	Applied Medical Resources Corp	GCJ	Class II	2006-04-07
K060507	Valplast Yamahachi Teeth	Valplast Intl. Corp.	ELM	Class II	2006-04-07