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 1553 of 3531

510(k) clearances, page 1553 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020083	Tuta Healthcare Arthroscopy Flushing Set, Model 80.601	Tuta Healthcare Pty Limited	HRX	Class II	2002-02-12
K014261	St/ar St and Arrhythmia Software, Model Release E.0	Philips North America LLC	MHX	Class II	2002-02-12
K013908	Waterlase Millennium	Biolase MG LLC	MXF	Class II	2002-02-12
K013904	Bmc Radio Frequency Perforation Generator, Models Rfp-100-115 and Rfp-100-230	Baylis Medical Co., Inc.	GEI	Class II	2002-02-12
K013887	Bacfix Spinal Fixation System	Spinal Concepts, Inc.	MNH	Class II	2002-02-12
K013872	Rusch Memory Bag	Rusch Intl.	GCJ	Class II	2002-02-12
K012976	Twin Plus	Grass-Telefactor Divison	OLV	Class II	2002-02-12
K012675	Reprocessed Used Disposable Sequential Compression Sleeves/wraps	Adven Medical	JOW	Class II	2002-02-12
K012490	Orion Digital Imaging System	Infimed, Inc.	OWB	Class II	2002-02-12
K012368	Aeropep	Trudell Medical Intl.	BWF	Class II	2002-02-12
K012003	Drg Reaction Chamber/safety Tip	Doctor'S Research Group, Inc.	HEI	Class II	2002-02-12
K011974	Sensaid	Sensidyne, Inc.	DQA	Class II	2002-02-12
K011835	Cobe Revolution	LivaNova USA, Inc.	KFM	Class II	2002-02-12
K010452	Bi-Directional Doppler Volume Flowmeter, Model Dvm-4300 & 4300T	Koven Technology, Inc.	DPW	Class II	2002-02-12
K020283	Back-Up Meier Steerable Guidewire	Boston Scientific Corporation	DQX	Class II	2002-02-11
K020281	Modification to Ventlab Hyperinflation Bag System	Salter Labs	NHK	Class II	2002-02-11
K020170	Keystone Hip System Calcar Replacement Body and Build Up	Encore Orthopedics, Inc.	LPH	Class II	2002-02-11
K020138	Stat-Site Mhgb Meter, Stat-Site Mhgb Meter Card Holder, Stat-Site Mhgb Test Cards, Stat-Site Mhgb Code Way, Models 90090	Gds Technology, LLC	KHG	Class II	2002-02-11
K020090	Modification to Transseptal Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	2002-02-11
K020052	Smart Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2002-02-11
K020009	Brace Eze	Udent, Inc.	EGD	Class I	2002-02-11
K014301	Modification to Merits Health Products Oxygen Concentrators	Merits Health Products, Inc.	CAW	Class II	2002-02-11
K014048	Clinicon Universal Waveguide Handpiece and Fiber Tips	Clinicon Corp.	GEX	Class II	2002-02-11
K013944	Jostra Dual Stage Venous Return Cannulae	Jostra AG	DWF	Class II	2002-02-11
K013812	Spirolab II, Model 29	Sdi Diagnostics, Inc.	BZG	Class II	2002-02-11
K013760	Dc-3300 Laser Diode Photocoagulator	Nidek, Inc.	HQF	Class II	2002-02-11
K013749	Endoanchor and Openanchor	Ethicon Endo-Surgery Inc	GDW	Class II	2002-02-11
K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corporation	GEX	Class II	2002-02-11
K013747	Tekno-Medical Obstetrical Forceps	Tekno Medical Optik-Chirurgie GmbH	HDA	Class II	2002-02-11
K013722	Modification to: Eub-8500 Diagnostic Ultrasound Scanner	Hitachi Medical Corp.	IYN	Class II	2002-02-11
K013635	Trellis Infusion System (10Cm Infusion Length); Trellis Infusion System (20Cm Infusion Length)	Bacchus Vascular, Inc.	QEY	Class II	2002-02-11
K013479	Complete Brand Multi-Purpose Solution	Allergan	LPN	Class II	2002-02-11
K013284	Lumend Frontrunner Cto Coronary Catheter	Lumend, Inc.	DQY	Class II	2002-02-11
K013223	Patient Ventilation Oxygen Concentrating System (Pvocs)	Litton Systems, Inc.	CAW	Class II	2002-02-11
K012811	Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-Mbb,10-Mbb-B,10-Mpb,10-Mpb-B	CooperSurgical, Inc.	MQH	Class II	2002-02-11
K012597	Sterilmed Reprocessed Compression Sleeves	Sterilmed Inc	JOW	Class II	2002-02-11
K012467	Solar 8000M System	General Electric Medical Systems Information Techn	DSI	Class II	2002-02-11
K012277	Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile	Abbott Medical	HHW	Class II	2002-02-11
K012052	Medtronic Ps Medical Strata Valve, Models 42855, 42865, 92865, 92855	Medtronic PS Medical	JXG	Class II	2002-02-11
K011275	Psychemedics Ria Phencyclidine Assay	Psychemedics Corp.	LCL	Unclassified	2002-02-11
K011106	Stonelith, Model V5	Pck Electronic Industry & Trade Co., Ltd.	LNS	Class II	2002-02-11
K010694	Includer Clamp	Novare Surgical Systems, Inc.	DXC	Class II	2002-02-11
K020284	Biotech Manual Wheelchair A2000 Super Motive Wheelchair	Taiwan Armada Enterprise Co., Ltd.	IOR	Class I	2002-02-08
K020264	Repicci II Unicondylar Knee System	Biomet Orthopedics, Inc.	HRY	Class II	2002-02-08
K020096	Esthetic Ease Abutments for the Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2002-02-08
K020088	Modification of the Bioplate Zip Craniotomy Fixation System	Bioplate Inc	GXN	Class II	2002-02-08
K020075	Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter	Dolphin Medical, Inc.	DQA	Class II	2002-02-08
K014160	Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)	Cook Incorporated	MQG	Class II	2002-02-08
K014120	Testosterone by Enzymeimmunoassay (Eia)	Diagnostics Biochem Canada, Inc.	CDZ	Class I	2002-02-08
K014038	Pyloritek Vp Test Kit 5140Vp	Serim Research Corp.	LYR	Class I	2002-02-08