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 1407 of 3531

510(k) clearances, page 1407 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K034014	Spi Contact Dental Implant	Thommen Medical AG	DZE	Class II	2004-03-05
K033810	Natural-Knee II Unicompartmental Knee System	Centerpulse Orthopedics, Inc.	HRY	Class II	2004-03-05
K033410	Tempus 2000 Patient Monitor, Model 00-0002	Remote Diagnostic Technologies Ltd.	DXH	Class II	2004-03-05
K033249	Pajunk Modular Handle Instruments	Pajunk GmbH Medizintechnologie	GCJ	Class II	2004-03-05
K033136	I-Lux Innova Blue Tint Lens, Model Super O2	Innova Vision Inc.	LPL	Class II	2004-03-05
K032688	Colonosight Model 510B	Sightline Technologies, Ltd.	FDF	Class II	2004-03-05
K032278	Ambu Neuroline Single Patient Eeg/ep Cup Electrode	Ambu, Inc.	GXY	Class II	2004-03-05
K031511	Dynesys Spinal System	Centerpulse Spine-Tech, Inc.	NQP	Class II	2004-03-05
K020895	Allomatrix Model# 86	Wrightmedicaltechnologyinc	MQV	Class II	2004-03-05
K040507	Taga Velocity Passover Humidifier with Heater, Model Tm1000h	Taga Medical Technologies, Inc.	BTT	Class II	2004-03-04
K040366	Pressure Manifold, Model Bc 110	Fisher & Paykel Healthcare, Inc.	CBP	Class II	2004-03-04
K040273	Lyphochek Assayed Chemistry Control	Bio-Rad Laboratories Inc.	JJY	Class I	2004-03-04
K040200	Mesacup-2 Test Cenp-B	Rhigene, Inc.	LJM	Class II	2004-03-04
K040180	Continum V	Aalba Dent, Inc.	EJH	Class II	2004-03-04
K033965	Shiraz-Anterior System	Spine Next America	KWQ	Class II	2004-03-04
K033947	Shiraz Posterior System	Spine Next America	MNI	Class II	2004-03-04
K033842	Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue	Vernon-Carus Limited	GCJ	Class II	2004-03-04
K033301	IV Administration and Connect Sets	Codan US Corp.	FPA	Class II	2004-03-04
K033060	Calibrating Material, Calibrating Standards	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2004-03-04
K032834	BIPAP Pro 2 Bi-Level System	Respironics, Inc.	BZD	Class II	2004-03-04
K032516	Hiox80 Aerosol Adapter	Sensor Medics Corp.	CAF	Class II	2004-03-04
K032454	Silhouette(tm) Ic or Silhouette(tm) & Laser-Lok (Tm)	Bio-Lok Intl., Inc.	DZE	Class II	2004-03-04
K031100	Synthes Ventrofix Mis System	Synthes (USA) Products LLC	KWQ	Class II	2004-03-04
K040357	M3290a Intellivue Information Center Software Release F.o and the M4840a Telemetry Monitoring System II	Philips North America LLC	MHX	Class II	2004-03-03
K040300	Stryker Consolidated Operating Room Equipment (Core)	Stryker Corp.	ERL	Class II	2004-03-03
K040247	Plume Safety Avf Needle	JMS North America Corp.	FIE	Class II	2004-03-03
K040210	Capiox Rx25 Hollow Fiber Oxygenator W/wo Hardshell Reservoir	Terumo Corp.	DTZ	Class II	2004-03-03
K040179	Continum	Aalba Dent, Inc.	EJH	Class II	2004-03-03
K040043	Ndx-40 Alloy	Kulzer GmbH	EJT	Class II	2004-03-03
K040037	Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	DQX	Class II	2004-03-03
K034066	B.braun Premixed Dialysate	B.Braun Medical, Inc.	KPO	Class II	2004-03-03
K034004	Diego RF Powered Dissector and Drill System Console	Gyrus Ent LLC	ERL	Class II	2004-03-03
K033980	Blackstone Ascent Poct System Hooks (System Modification)	Blackstone Medical, Inc.	KWP	Class II	2004-03-03
K033531	Powdered Latex Examination Gloves	Apl International Incorporated Limited	LYY	Class I	2004-03-03
K032840	Atrion Medical Ql Inflation Device	Atrion Medical Products, Inc.	KOE	Class II	2004-03-03
K032733	Pm-8000 Patient Monitor, Model 8000	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	DRT	Class II	2004-03-03
K031935	Tiara Medical Systems Advantage II Nasal Mask, Models Tms-2520 and Tms-2530	Tiara Medical Systems, Inc.	BZD	Class II	2004-03-03
K031930	High Speed EMG Module	Medical Measurement Systems B.V.	GWF	Class II	2004-03-03
K031903	Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568	Boston Scientific Corporation	DTZ	Class II	2004-03-03
K031114	Pro-Pact Peracetic Acid Culture Test Kit, Model C-3Pa	Raven Biological Laboratories, Inc.	MRB	Class II	2004-03-03
K040345	Modification to Nitrex Nitinol Guidewire	Medtronic, Inc.	DQX	Class II	2004-03-02
K040279	Vivaring Microwave Ablation Probe	Vivant Medical, Inc.	GEI	Class II	2004-03-02
K040025	A1c-Cellular	Streck Laboratories, Inc.	JJX	Class I	2004-03-02
K033887	Non-Sterile Blue & White Colour Powder Free Barrier Pro Polybutadiene Copolymer Examination Gloves	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2004-03-02
K033881	Medrad Stellant CT Injector System with Imaging System Interface Module	Medrad, Inc.	DXT	Class II	2004-03-02
K033851	Diascreen Reagent Strips for Urinalysis, Models D122oo (2Gk), D12100 (1K), D11100 (1G)	Arkray Factory USA, Inc.	JIL	Class II	2004-03-02
K033816	Synthes (USA) Modification to Sternal Reconstruction System	Synthes (USA) Products LLC	JDQ	Class II	2004-03-02
K033774	CT-Mass	Medis Medical Imaging Systems, B.V.	JAK	Class II	2004-03-02
K033619	Navigus Unibody Fiducial Marker System, Model Fm-4000	Image-Guided Neurologics, Inc.	HAW	Class II	2004-03-02
K033555	Kenkowave Infrared Pain Treatment System	Kaylight Corporation	ILY	Class II	2004-03-02