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 1316 of 3531

510(k) clearances, page 1316 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050570	Miltex Rigid Sterilization Container System	Miltex, Inc.	KCT	Class II	2005-07-25
K043055	Terraquant Mq2000 Laser Therapy Device	Escada International, Inc.	ILY	Class II	2005-07-25
K051751	Equa-Pull Safety Release Module	Ortho Technology	DZB	Class II	2005-07-22
K051662	Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color)	Grand Work Plastic Products Co., Ltd.	LZA	Class I	2005-07-22
K051652	Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment	Atlantis Components, Inc.	NHA	Class II	2005-07-22
K051627	Valleylab G3000 Electrosurgical Instrument	Medtronic, Inc.	GEI	Class II	2005-07-22
K051443	Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio	Curasan AG, Frankfurt Facility	LYC	Class II	2005-07-22
K051365	Compressor Nebulizer System, Model Kn-9321	K-Jump Health Co., Ltd.	CAF	Class II	2005-07-22
K051333	Nitrile Examination Gloves, Powder Free	Shun Thai Rubber Gloves Industry Co., Ltd.	LZA	Class I	2005-07-22
K051249	Zirox	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2005-07-22
K051180	Vanguard Reprocessed External Fixation Devices	Stryker Sustainability Solutions	KTT	Class II	2005-07-22
K050574	Afinion Hbalc	Axis-Shield Poc AS	LCP	Class II	2005-07-22
K040283	Biopad	Euroresearch S.r.l.	QSY	Unclassified	2005-07-22
K033028	Anefin, Model 100	Axon Medical	CBN	Class II	2005-07-22
K051797	Future Wash/yps	3M Espe AG Dental Products	ELW	Class II	2005-07-21
K051674	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2005-07-21
K051538	Avanticare, Model Sa4022	Lerado China Limited	INI	Class II	2005-07-21
K051410	Acumed Rib Congrient Bone Plate System	Acumed LLC	HRS	Class II	2005-07-21
K051256	Silverseal Orthotic Component with X-Static	Noble Fiber Technologies, Inc.	ISH	Class I	2005-07-21
K051215	Cell-Dyn Sapphire System	Abbott Medical	GKZ	Class II	2005-07-21
K051053	Oscar, Model Oe3000db	Orthosonics, Ltd.	JDX	Class II	2005-07-21
K050391	Protex CT Cervicothoracic Spinal System	Globus Medical, Inc.	KWP	Class II	2005-07-21
K043322	Miramatic Safe Syringe System	Hager Worldwide, Inc.	EJI	Class II	2005-07-21
K041849	Turbo-Flo Picc	Cook Inc.	LJS	Class II	2005-07-21
K051837	Mylab 90 Ultrasound Imaging System, Model 6100	Esaote S.p.A.	IYN	Class II	2005-07-20
K051784	Osteovation Cmf Bone Void Filler	Skeletal Kinetics, LLC	GXP	Class II	2005-07-20
K051728	Modification to Shoulder Fixation System	Hand Innovations, Inc.	LXT	Class II	2005-07-20
K051664	Scan300fp / Retropan (Vdc)	Oy Ajat, Ltd.	MUH	Class II	2005-07-20
K051628	Infinity Monitors with Scio Modifications	Draeger Medical Systems, Inc.	MHX	Class II	2005-07-20
K051528	Mevis Liveranalyser/liverviewer Software	Mevis Technology GmbH & Co. KG	LLZ	Class II	2005-07-20
K051523	Regius Console Cs-2000 and Regius Console Cs-3000, Medical Image Processing Workstation	Konica Minolta Medical & Graphic, Inc.	LLZ	Class II	2005-07-20
K051229	Profix Flex Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	JWH	Class II	2005-07-20
K050136	Reprocessed Hot Biopsy Forceps	Sterilmed Inc	NLU	Class II	2005-07-20
K042648	Reprocessed Cold Biopsy Forceps	Sterilmed Inc	NON	Class I	2005-07-20
K051738	Secur-Fit Max and Plus Max Hip Stems	Howmedica Osteonics Corp	LZO	Class II	2005-07-19
K051737	Modification to V-40/C-Taper Adapter Sleeve	Howmedica Osteonics Corp	LZO	Class II	2005-07-19
K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	HRS	Class II	2005-07-19
K051724	Acumen Image Guided Surgical System	Ebi, LLC	HAW	Class II	2005-07-19
K051710	Thermage Thermacool Coupling Fluid	Solta Medical, Inc.	GEI	Class II	2005-07-19
K051695	Marrow Plus (M+)	Berkeley Advanced Biomaterials	MQV	Class II	2005-07-19
K051682	Exactech 12/14 Alumina Femoral Heads 36 Mm	Exactech, Inc.	LZO	Class II	2005-07-19
K051634	Datex-Ohmeda S/5 Device Interfacing Solution	GE Healthcare	MSX	Class II	2005-07-19
K051623	Anatomical Shoulder Keeled Glenoid	Zimmer GmbH	KWS	Class II	2005-07-19
K051599	Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and Relief (Ciper) Kit	Neurorecovery, Inc.	GWM	Class II	2005-07-19
K051571	Skylight LED Curing Light	Dmetec.Co., Ltd.	EBZ	Class II	2005-07-19
K051329	Sterile Powder-Free Latex Examination Gloves with Polymer Coating and Protein Claim (50 Ug or Less)	Siam Sempermed Corp., Ltd.	LYY	Class I	2005-07-19
K051216	Hydralok System	Altiva Corp.	MNH	Class II	2005-07-19
K051162	Generos Sb Small Bone Distraction Implant	Orthonetx, Inc.	KTT	Class II	2005-07-19
K051026	Mars Holter Analysis Workstation	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2005-07-19
K051012	Progesterone Standard Calibrator, One (1) Ml of Progesterone in a Saliva-Like Matrix at a Concentration of 2430 Pg/ml.	Salimetrics LLC.	JIT	Class II	2005-07-19