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 2387 of 3531

510(k) clearances, page 2387 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914036	Medsurg Laparoscopy Tray	Medsurg Industries, Inc.	LRO	Class II	1992-03-18
K913985	Transfer-Aid(tm)	Healthtek, Inc.	LHI	Class II	1992-03-18
K912935	Ams Malleable 600 and 600M Penile Prosthesis	American Medical Systems, Inc.	FAE	Class II	1992-03-18
K912934	Ams Sphincter 800 Urinary Prosthesis	American Medical Systems, Inc.	FAG	Class III	1992-03-18
K912378	Davis Lead Apron/radiographic Various Cat. Numbers	Davis Lead Aprons, Inc.	KPY	Class I	1992-03-18
K912327	Davis Lead Apron Gonadal Shield-Various Cat. Nos.	Davis Lead Aprons, Inc.	KPY	Class I	1992-03-18
K912326	Davis Lead Apron - Various Catalogue Numbers	Davis Lead Aprons, Inc.	KPY	Class I	1992-03-18
K910290	Viratest-Dia(tm) Measles (Rubeola)	Virus Reference Laboratory, Inc.	LJB	Class I	1992-03-18
K920530	Intermedics Model 366-15 Vs 1 Header Plug	Intermedics, Inc.	DXY	Class III	1992-03-17
K920364	Electrocardiograph Stress Test Firmware Actavis	Biosound, Inc.	DPS	Class II	1992-03-17
K920300	B2-Microglobulin Radioimmunoassay	Nichols Institute	JZG	Class II	1992-03-17
K915850	Opus Myoglobin Test System	Pb Diagnostic Systems, Inc.	DDR	Class II	1992-03-17
K915823	Dsl Active Shbg (Dsl 7400)	Diagnostic Systems Laboratories, Inc.	CDZ	Class I	1992-03-17
K915508	Dsl Active Beta2-Microglobulin (Dsl 6500)	Diagnostic Systems Laboratories, Inc.	JZG	Class II	1992-03-17
K915366	Model 560 Express Clinical Chemistry Analyzer	Ciba Corning Diagnostics Corp.	JJE	Class I	1992-03-17
K915272	Hemagen Ena [Rnp/sm] Kit (Eia Method)	Hemagen Diagnostics, Inc.	LJM	Class II	1992-03-17
K914204	Tri-Point Liquimmune Ligand Control Levels 1,2,3	Medical Analysis Systems, Inc.	JJY	Class I	1992-03-17
K914167	Clinical Chem.anal.acid,prostatic Acid Phosphatase	Eastman Kodak Company	CKE	Class II	1992-03-17
K920157	Schneider 8 Fr. Stamina(tm) Guiding Catheter	Schneider Intl., Ltd.	DXY	Class III	1992-03-16
K920156	Clinical Neuro Syst Monitorr Ext Csf Drain/moni Sy	Clinical Neuro Systems, LLC	JXG	Class II	1992-03-16
K915873	Mos-III	Sherman Ophthalmic Supplies, Inc.	LNH	Class II	1992-03-16
K915800	Bremer Halo System Cervical Traction Skull Pin	Bremer Medical, Inc.	JEC	Class II	1992-03-16
K915754	16 Bit A/d	Resonex, Inc.	LNH	Class II	1992-03-16
K915628	Dextrolyte II Peritoneal Dialysis Pump	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1992-03-16
K915260	MRI Ultraview	A&E Specialty Fabricators	LNH	Class II	1992-03-16
K914928	Basic Set Up Tray	Westmark Hospital Supplies	GEI	Class II	1992-03-16
K914880	Dual Balloon Embolectomy Catheter	Ideal Medical, Inc.	DXE	Class II	1992-03-16
K914363	Peritoneal Dialysis Cycler Set	National Medical Care, Medical Products Div., Inc.	KDI	Class II	1992-03-16
K912283	Detachable, Disposable Monopolar Needle Electrode	Chalgren Enterprises, Inc.	IKT	Class II	1992-03-16
K912282	Disposable Monopolar Needle Electrode, Var Models	Chalgren Enterprises, Inc.	IKT	Class II	1992-03-16
K920883	Hemostat, Surgical (Various Types)	S.T.S Instruments	EMD	Class I	1992-03-13
K920751	Syva Emit II Methadone Assay	Syva Co.	DJR	Class II	1992-03-13
K920519	Lumbar Cpm	Rehabilitative Resources, Inc.	BXB	Class I	1992-03-13
K920221	Healthtest Infectious Mononucleosis Assay	Akers Research Corp.	KTN	Class II	1992-03-13
K920220	Healthtest Rheumatoid Factor Assay	Akers Research Corp.	DHR	Class II	1992-03-13
K920107	Adl 800 Nd:yag Laser System for Intraoral Tis. Sur	Sunrise Technologies, Inc.	GEX	Class II	1992-03-13
K920106	Adl 400 Nd;yag Laser System for Introral Soft Tis.	Sunrise Technologies, Inc.	GEX	Class II	1992-03-13
K920010	Il Test Complement 4	Instrumentation Laboratory Co.	DBI	Class II	1992-03-13
K920006	Il Test Immunoglobulin G (Igg)	Instrumentation Laboratory Co.	CGM	Class II	1992-03-13
K920003	Drg Cemeted Stem	Intermedics Orthopedics	JDI	Class II	1992-03-13
K915788	Mis Electrosurgical Electrodes	Beacon Laboratories, Inc.	GEI	Class II	1992-03-13
K915762	Poole Tip Suction Probe	O.R. Concepts, Inc.	GCI	Class II	1992-03-13
K915745	D7113 Anvil Cutter and D7112 Air-Powered Handle	Storz Instrument Co.	HQE	Class II	1992-03-13
K915657	Modified Magnetic Resonance Imaging Sytem Mod. R28	Bruker Medical Imaging, Inc.	LNH	Class II	1992-03-13
K914864	Models C500/c550 Isolete(r) Infant Incubator	Air-Shields, Inc.	FMZ	Class II	1992-03-13
K914554	Specific Ige Eia-Turbo Assay	Ventrex Laboratories, Inc.	DHB	Class II	1992-03-13
K913839	Optica 25 Nd:yag Dental Laser System	Xintec Corporation	GEX	Class II	1992-03-13
K913472	Laparoscan(tm) Intraoper Diag Ultrasound System	Baxter Healthcare Corporation	ITX	Class II	1992-03-13
K903870	Kinesthetics Model 2000 Nms	Kinesthetics, Inc.	IPF	Class II	1992-03-13
K920654	Shoprider - Te889	Pride Health Care, Inc.	INI	Class II	1992-03-12