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 1549 of 3531

510(k) clearances, page 1549 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020156	Diastat Total Anti-Cardiolipin, Model Fcar 100T	Axis-Shield Diagnostics, Ltd.	MID	Class II	2002-03-06
K014111	Rebilda Sc	Voco GmbH	EBF	Class II	2002-03-06
K013473	Xtd Thrombectomy Catheter, Xx Cm, Model# Ct000500x; Xtd Control Console, Model # Ct0006001; Xtd Collection Bottle, Model	Xtrak Medical, Inc.	MCW	Class II	2002-03-06
K012957	Towel Drape, Models 4409, 4410	Dynarex Corp.	KKX	Class II	2002-03-06
K012414	Prime ECG System	Meridian Medical Technologies, Ltd.	DPS	Class II	2002-03-06
K020243	Laserpro 16	Eradlink, Inc.	LMA	Class II	2002-03-05
K020060	Astoflo	Nats Corp.	BSB	Class II	2002-03-05
K014204	Arm Blood Pressure Monitor, Models Kp-6821, Kp-6822	K-Jump Health Co., Ltd.	DXN	Class II	2002-03-05
K014081	Aktina Medical Physics Radiation Therapy Wedges	Aktina Medical Physics Corp.	IYE	Class II	2002-03-05
K014060	Microaire 1000E System	MicroAire Surgical Instruments, LLC	HBE	Class II	2002-03-05
K013821	Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim (200 Micrograms or Less)	Top Quality Mfg., Inc.	LYY	Class I	2002-03-05
K013774	Chlorinated Powder Free Nitrile Medical Examination Gloves with Aloe Vera	Supermax Sdn Bhd	LZA	Class I	2002-03-05
K013653	Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe	Hollister, Inc.	HIR	Class II	2002-03-05
K013433	Trojan Passion Berry Gel	Armkel, LLC	NUC	Class II	2002-03-05
K012189	Angeltouch Vented IV Administration Set	Angiplast Private, Ltd.	LHI	Class II	2002-03-05
K010761	Spl-50 Spirolyser	Fim Medical	BZG	Class II	2002-03-05
K020572	Accolade Tmzf Ha 132 Degree Size 0 Hip Stem	Howmedica Osteonics Corp	MEH	Class II	2002-03-04
K020497	Trident Elevated Rim Liner	Howmedica Osteonics Corp	LPH	Class II	2002-03-04
K020428	Endopath Dilating Tip Trocar, Model #512Xd	Ethicon Endo-Surgery Inc	GCJ	Class II	2002-03-04
K020223	Invigra	Indus Medicare, Ltd.	HIS	Class II	2002-03-04
K020157	Temporary Crown and Bridge Material	J. Morita USA, Inc.	EBG	Class II	2002-03-04
K020137	Ahp-66 4:1 Reduction Contrangle: Ahp-88 8:1 Reduction Contrangle: Ahp-88Mp 8:1 Reduction Contrangle - Push Button	Aseptico, Inc.	EGS	Class I	2002-03-04
K020068	Sonoreal 3D System	Bio Medi Com	IYO	Class II	2002-03-04
K014170	Staurenghi Wide Field Scanning Laser Lens	Ocular Instruments, Inc.	HJK	Class II	2002-03-04
K014087	Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder-Free Rubber Latex Examination Glove	Latexx Manufacturing Sdn.Bhd.	LYY	Class I	2002-03-04
K014044	Mascular Computerized Psychophysical Test (Mcpt)	Notal Vision Ltd.	HOQ	Class I	2002-03-04
K014022	MRI Line Marker	I.Z.I. Corp.	IYE	Class II	2002-03-04
K014002	All Silicone Supra-Pubia Catheter, Models 4880/4890	Fortune Medical Instrument Corp.	KOB	Class II	2002-03-04
K013876	Infrared Ear Thermometer, Model Dx-707	Jawon Medical Co., Ltd.	FLL	Class II	2002-03-04
K013680	Carbodissecting Endoscope	Endo Surgical Devices, Inc.	GEI	Class II	2002-03-04
K013353	Neurospectquad Gamma Camera	Nuclear Cardiology Systems, Inc.	KPS	Class II	2002-03-04
K012732	Integraph Flash, Model Ci 110	Steritec Products, Inc.	JOJ	Class II	2002-03-04
K012294	Wristore Fixator	Millennium Medical Technologies, Inc.	KTT	Class II	2002-03-04
K011269	Lifemate Mla Multi-Line Adaptor; Lifemate Sfr Sterile Fluid Reservoir	NxStage Medical Inc	KDI	Class II	2002-03-04
K001638	O-Ring Prosthetic Attachment	Titan Implants, Inc.	DZE	Class II	2002-03-04
K020521	Modification to Vigil Lipid Control	Siemens Healthcare Diagnostics Inc.	JJY	Class I	2002-03-01
K020340	Modification to Hi-Torque Whisper Ls and Ms Guide Wires with Hydrocoat Hydrophilic Coating	Boston Scientific Corporation	DQX	Class II	2002-03-01
K020128	Active Free Beta-Hcg Elisa, Model Dsl-10-8500	Diagnostic Systems Laboratories, Inc.	JHI	Class II	2002-03-01
K014300	Safetouch	James D Rusin MD, MBA	NHM	Class II	2002-03-01
K014276	Modification to Ebi Xfix Dfs System	Ebi, LLC	KTT	Class II	2002-03-01
K013987	Reprocessed Disposable Trocars	Adven Medical	KBG	Class I	2002-03-01
K013737	Modification to: 3-Lumen Duralon Occlusion Balloon	TeleMed Systems	FGE	Class II	2002-03-01
K013054	Konica Direct Digitizer Regius Model 350	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2002-03-01
K012535	Drg Disposable Vaginal Speculum	Doctor'S Research Group, Inc.	HIB	Class II	2002-03-01
K011030	Aesculap -Miethke Shunt System	Aesculap Inc	JXG	Class II	2002-03-01
K020504	Infrared Ear Thermometer, Models Th88 Series	Radiant Innovation Inc.	FLL	Class II	2002-02-28
K020483	Advantage Workstation 4.1	GE Healthcare	LLZ	Class II	2002-02-28
K020282	Jas Amylase Liquid Reagent	JAS Diagnostics/Drew Scientific	JFJ	Class II	2002-02-28
K020193	Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens	Cl Mcintosh	LPL	Class II	2002-02-28
K020131	Venus Universal Light Curing Composite	Kulzer GmbH	EBF	Class II	2002-02-28