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 1460 of 3531

510(k) clearances, page 1460 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030718	Scb Computer Motion Interface Controller	Computer Motion, Inc.	GCJ	Class II	2003-06-05
K030636	C-Port	Clinisurg Vascular Products, LLC	LJT	Class II	2003-06-05
K030445	Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less Protein Gram	Primus Gloves Private Ltd.	KGO	Class I	2003-06-05
K030444	Pre-Powdered Latex Orthopedic Surgeon's Gloves	Primus Gloves Private Ltd.	KGO	Class I	2003-06-05
K022394	Ezmanager Plus	Animas Corp.	LZG	Class II	2003-06-05
K022393	Merdoc System	Stryker Corp.	GCJ	Class II	2003-06-05
K031488	Cynosure Apogee-Tks II Dermatological Laser	Cynosure, LLC	GEX	Class II	2003-06-04
K031303	Aesculap-Miethke Shunt System Gravity Assisted Valve (Gav)	Aesculap Inc	JXG	Class II	2003-06-04
K031098	3-Ccd Digital Camera System	Linvatec Corporation	GCJ	Class II	2003-06-04
K030824	Lap Disc 120 X 120Mm X2cm, Model Ld111, Lap Disc 120 X 120Mmx 7Cm,model Ld112	Hakko Medical Co., Ltd.	GCJ	Class II	2003-06-04
K030710	Bio-Modular Shoulder System	Zimmer GmbH	KWT	Class II	2003-06-04
K030700	Ceralas D 10-60 810Nm Laser System with Endo Laser Vein System Kit	Biolitec, Inc.	GEX	Class II	2003-06-04
K024179	Palomar Lightcube	Palomar Medical Products, Inc.	ILY	Class II	2003-06-04
K023940	Shelhigh Bioring	Shelhigh, Inc.	KRH	Class II	2003-06-04
K023691	Boston Scientific Filterwire Ex Embolic	Boston Scientific Epi	NFA	Class II	2003-06-04
K031000	Labsystem III Ep Laboratory W/windows Platform & Windows Ep Software Version 1.0	C.R. Bard Inc	DQK	Class II	2003-06-03
K030913	Nanma Vacuum Pump	Nanma Mfg Co., Ltd.	LKY	Class II	2003-06-03
K030822	7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/nppv Masks	Hans Rudolph, Inc.	BZD	Class II	2003-06-03
K030724	Alumina Ceramic Femoral Heads, 28 and 32 Mm	Zimmer GmbH	LZO	Class II	2003-06-03
K030720	Ultrablator Electrode	Linvatec Corporation	GEI	Class II	2003-06-03
K030684	Scope Guard Protective Sheath, Model Tel-Sh	Acmi Corporation	OCU	Class II	2003-06-03
K030640	Siemens Micro2+ with Vai Software	Siemens Medical Solutions USA, Inc.	DQA	Class II	2003-06-03
K024344	Pneuton Ventilator	Airon Corporation	CBK	Class II	2003-06-03
K024019	Arterialflow System, Model 32A	Aircast, Inc.	JOW	Class II	2003-06-03
K023195	Maglife C/maglife C Plus	Schiller Medical	MWI	Class II	2003-06-03
K021993	Shanchuan Syringe	Shangdong Zibo Shanchuan Medical Instruments Co.	FMF	Class II	2003-06-03
K031506	Access Immunoassay System Toxo Igm II Assay	Siemens Healthcare Diagnostics Inc.	LGD	Class II	2003-06-02
K031306	Bd Phoenix Automated Microbiology System - Moxifloxacin Gram Positive	Becton Dickinson & Co	LON	Class II	2003-06-02
K031135	Glucose Flex Reagent Cartridge (Gluc)	Siemens Healthcare Diagnostics Inc.	CFR	Class II	2003-06-02
K030848	Perforated Bioabsorbable Interference Screw Megafix	Karl Storz Endoscopy-America, Inc.	HWC	Class II	2003-06-02
K030546	Crp (II) Calibrators	Denka Seiken Co., Ltd.	JIS	Class II	2003-06-02
K030545	Crp-Latex (Ii)x2 Seiken Assay Kit	Denka Seiken Co., Ltd.	DCK	Class II	2003-06-02
K022579	Stryker Navigation System-Knee Module	Stryker Leibinger	HAW	Class II	2003-06-02
K031552	Mycolor 202 Diagnostic Ultrasound System and Transducers	Medison America, Inc.	IYN	Class II	2003-05-30
K031543	Starcast Dental Alloys	Star Refining Precious Metals South Africa	EJT	Class II	2003-05-30
K031508	Synthes (USA) Sternal Reconstruction System	Synthes (USA) Products LLC	JDQ	Class II	2003-05-30
K031406	Exojet Tissue Management System	Mitek Worldwide	HRX	Class II	2003-05-30
K031403	M3290a Intellivue Information Center Software Release E.1	Philips North America LLC	MHX	Class II	2003-05-30
K031378	Fresenius Ultraflux Hemodialyzer	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2003-05-30
K031364	Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3	Medical Analysis Systems, Inc.	JJY	Class I	2003-05-30
K031362	Lac-Mac Limited Innerbloc Various o.r. Drape Based on the Repel, Plus and Gore Surgical Barrier Fabric Materials	Lac-Mac Limited	KKX	Class II	2003-05-30
K031279	Surshield Safety Winged Blood Collection Set	Terumo Medical Products (Hangzhou) Co., Ltd.	FPA	Class II	2003-05-30
K031266	Surshield Safety Winged Infusion Set	Terumo Corp.	FPA	Class II	2003-05-30
K031017	Sys*stim 208 and 208A	Mettler Electronics Corp	IPF	Class II	2003-05-30
K030996	Msi Sa Electrodes	Medsphere International, Inc.	GEI	Class II	2003-05-30
K030976	Careo Retractable Safety Syringe	Life-Shield Products, Inc.	MEG	Class II	2003-05-30
K030972	Fixion Unipolar Modular Hemi-Hip System (Fixion Mh)	Disc-O-Tech Medical Technologies, Ltd.	KWL	Class II	2003-05-30
K030915	Grandio	Voco GmbH	EBF	Class II	2003-05-30
K030914	Rebilda Dc	Voco GmbH	EBF	Class II	2003-05-30
K030839	Medtronic Ave Bridge Aurora Biliary Stent System (Aurora)	Medtronic, Inc.	FGE	Class II	2003-05-30