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 1097 of 3531

510(k) clearances, page 1097 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K082875	Portable X-Ray System, Model Dxr -1	Exaro Co., Ltd.	EHD	Class II	2009-02-05
K082874	Biodrive Cannulated Screw System	Biomet Trauma	HWC	Class II	2009-02-05
K082833	Nbx - Non-Bridging External Fixator - Shoulder	NUTEK Orthopaedics, Inc	KTT	Class II	2009-02-05
K090170	Spyscope Access and Delivery Catheter	Boston Scientific Corporation	ODF	Class II	2009-02-04
K083898	Surgimend	Integra LifeSciences Braintree Inc.	FTM	Class II	2009-02-04
K083781	Eea Hemorrhoid Stapler & Accessories	Surgical Devices, A Global Business Unit Covidien	GDW	Class II	2009-02-04
K083523	Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe	Merit Medical Systems, Inc.	DXT	Class II	2009-02-04
K083300	Gore Flow Reversal System	W. L. Gore & Associates, Inc.	NTE	Class II	2009-02-04
K083153	Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007	Hollister, Inc.	KNT	Class II	2009-02-04
K083034	Fotona Xd-2 Diode Laser System, Model Md01-2F	Fotona D.D.	GEX	Class II	2009-02-04
K082691	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Hebei Handform Plastic Products Co., Ltd.	LYZ	Class I	2009-02-04
K082150	Modification to Paxgene Blood RNA System	Preanalytix GmbH	NTW	Class II	2009-02-04
K082082	Gish Svr Soft Venous Reservoirs with Ha Coating	Gish Biomedical, Inc.	DTN	Class II	2009-02-04
K081947	Gish Capvrf44 Hardshell Venous Reservoir with Ha Coating	Gish Biomedical, Inc.	DTN	Class II	2009-02-04
K081495	Cell-Dyn Emerald System	Abbott Medical	GKZ	Class II	2009-02-04
K081372	Gelx Oral Gel	Bmg Pharma, LLC	OLR	Unclassified	2009-02-04
K080910	Pathiam System for Her2/neu Immunohistochemistry Reagents & Kits	Bioimagene, Inc.	NOT	Class II	2009-02-04
K080779	Irrisept Wound Cleansing System	IrriMAX Corporation	FQH	Class II	2009-02-04
K083621	Medpor Customized Surgical Implant	Porex Surgical, Inc.	JOF	Class II	2009-02-03
K083420	Medonic M Series	Boule Medical AB	GKZ	Class II	2009-02-03
K083287	Avivo Mobile Patient Management System	Corventis, Inc.	DSI	Class II	2009-02-03
K083269	Crossover	Merit Medical Systems, Inc.	DYB	Class II	2009-02-03
K083265	Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381	Agamatrix	NBW	Class II	2009-02-03
K083221	Aidera Diasend	Aidera AB	MRZ	Class II	2009-02-03
K083200	X-Cal	Streck LLC	KRX	Class II	2009-02-03
K083127	Asahi Corsair Microcatheter	Asahi Intecc Co., Ltd.	DQY	Class II	2009-02-03
K083002	Sysmex Uf-500I Automated Urine Particle Analyzer	Sysmex America, Inc.	LKM	Class II	2009-02-03
K082407	Modification to Ultralight II Nd: Yag Laser System	Sandstone Medical Technologies, LLC	GEX	Class II	2009-02-03
K082400	Deionizer and Carbon Exchange Service for Hemodialysis	Culligan Soft Water Service Co.	FIP	Class II	2009-02-03
K082162	Coulter Body Fluid Control	Siemens Healthcare Diagnostics Inc.	JPK	Class II	2009-02-03
K081576	Blazer Dx-20 Diagnostic Catheter	Boston Scientific Corporation	DRF	Class II	2009-02-03
K090027	Blood Pressure Monitor, Zsbp-003/004/005/006/007/008 and Zsbp-102/103/104/105/106/107	Zen Strong Medical Technology Co., Ltd.	DXN	Class II	2009-02-02
K083918	Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250	Advanced Technology Laser Co., Ltd.	GEX	Class II	2009-02-02
K083748	Ipulse, Model: I150	Cyden Limited	GEX	Class II	2009-02-02
K083711	Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34	Barrx Medical, Incorporated	GEI	Class II	2009-02-02
K083667	Needle Guide for 8814, Model Ua1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337	BK Medical ApS	ITX	Class II	2009-02-02
K083544	Kat Implant System	Kat Implants, LLC	NHA	Class II	2009-02-02
K083373	Immulite 2000 Free T4	Siemens Healthcare Diagnostics Inc.	CEC	Class II	2009-02-02
K083338	Cardiff Anterior Cervical Plate System	Seaspine, Inc.	KWQ	Class II	2009-02-02
K083313	Wildcat 7F Guidewire Support Catheter	Avinger, Inc.	DQY	Class II	2009-02-02
K083152	Equashield System	Plastmed, Ltd.	LHI	Class II	2009-02-02
K083067	Ms System	OSSTEM Implant Co., Ltd.	DZE	Class II	2009-02-02
K082262	Ldr Spine Roi Interbody Fusion System	Ldr Spine USA	MAX	Class II	2009-02-02
K081556	Cadstream, Version 5.0	Confirma, Inc.	LLZ	Class II	2009-02-02
K080708	Vision Hollow Fiber Oxygenator with Ha Coating	Gish Biomedical, Inc.	DTZ	Class II	2009-02-02
K090091	Olecranail Intramedullary Fixation System	Mylad Orthopedic Solutions, LLC	HSB	Class II	2009-02-01
K090098	Maxim Hygiene Organically Grown Cotton Tampon	Maxim Hygiene Products, Inc.	HEB	Class II	2009-01-30
K090096	All-in-One Container	Baxter Healthcare Corporation	KPE	Class II	2009-01-30
K090023	If Series True Sine Interferential Stimulator, Model: Wl-2206B and Wl-2106E	Well-Life Healthcare Limited	LIH	Class II	2009-01-30
K083882	Mylabfive	Esaote Europe B.V.	IYN	Class II	2009-01-30