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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 731 of 3530

510(k) clearances, page 731 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133959	Podiatry X-Ray System	Source-Ray, Inc.	KPR	Class II	2015-01-22
K143366	ADVANCE Porous Coated Spiked Tibial Base	Microport Orthopedics Inc.	MBH	Class II	2015-01-21
K143299	Percuvance(R) Percutaneous Surgical System	Teleflexmedical, Inc.	GCJ	Class II	2015-01-21
K143065	NuVasive ALIF Buttress Plate System	Nu Vasive, Incorporated	KWQ	Class II	2015-01-21
K142866	Myoscience iovera system	Myoscience, Inc.	GXH	Class II	2015-01-21
K142860	Lumenis M22 System	Lumenis Ltd	GEX	Class II	2015-01-21
K142791	Spectra Soft Tissue Biopsy Needles	Spectra Medical Devices, LLC	KNW	Class II	2015-01-21
K142678	Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm	Oticon Medical AB	MAH	Class II	2015-01-21
K142572	Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System	ZimVie US Corp LLC	NHA	Class II	2015-01-21
K142360	Everest Spinal System	K2M, Inc	NKB	Class II	2015-01-21
K142107	Echo True 3D Viewer	Echopixel, Inc.	LLZ	Class II	2015-01-21
K142104	Nanofuse Dbm	Nanotherapeutics	MQV	Class II	2015-01-21
K142025	Neurolumen Pn-1000	Neurolumen LLC	ILY	Class II	2015-01-21
K141707	Ultraskin Hydrophilic Guide Wire	Lepu Medical Technology (Beijing) Co., Ltd	DQX	Class II	2015-01-21
K141599	Divergence Anterior Cervical Fusion System	Medtronic Sofamor Danek USA Inc	OVE	Class II	2015-01-21
K140706	Levo Max	Levo AG	ITI	Class II	2015-01-21
K143634	MUSE System	Medigus, Ltd.	ODE	Class II	2015-01-20
K143498	LifeGlobal Global HP	Life Global Group, LLC	MQL	Class II	2015-01-20
K143317	Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)	Currie Medical Specialties, Inc.	JOW	Class II	2015-01-20
K143182	Speedicath Compact Male	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2015-01-20
K143037	SnapShot Fixation System	Biomet Manufacturing Corp	JDR	Class II	2015-01-20
K142838	Synapse Occipital-Cervical-Thoracic (OCT) System	Synthes (USA) Products LLC	NKG	Class II	2015-01-20
K142825	Zmachine	Consolidated Research of Richmond, Inc.	OLZ	Class II	2015-01-20
K142155	Endochoice Water Bottle Cap System	Boston Scientific Corporation	FEQ	Class II	2015-01-20
K142109	Sterilucent Sterilization Container System	Sterilucent, Inc.	KCT	Class II	2015-01-20
K140898	Patient Specific Distal Femoral	Stanmore Implants Worldwide, Ltd.	KRO	Class II	2015-01-20
K140736	Sterisafe Hp Table-Top Steam Sterilizer	Milton E Pedrazzi D.D.S., Inc.	FLE	Class II	2015-01-20
K140037	Optimus Cmf System	Osteonic Co., Ltd.	JEY	Class II	2015-01-20
K142749	TruWave Disposable Pressure Transducer	Edwards Lifesciences LLC	DXO	Class II	2015-01-18
K142106	Decisio Health Patient Dashboard	Decisio Health, Inc.	MWI	Class II	2015-01-18
K143614	Arthrex Low Profile Screws	Arthrex GmbH	HWC	Class II	2015-01-16
K143589	GEM Flow COUPLER Device and System	Synovis Life Technologies, Inc.	MVR	Class II	2015-01-16
K143573	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific Ltd.	JJY	Class I	2015-01-16
K143298	Ultrasound Scanner System bk2300	BK Medical ApS	IYN	Class II	2015-01-16
K143190	Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens	Yung Sheng Optical Co., Ltd.	MVN	Class II	2015-01-16
K143166	Medline ReNewal Reprocessed Compression Limb Sleeves	Surgical Instrument Service and Savings (dba Medline Renewal	JOW	Class II	2015-01-16
K143139	Arthrex Fracture System	Arthrex GmbH	HRS	Class II	2015-01-16
K143039	CrossRoads Screw System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	HWC	Class II	2015-01-16
K143023	Nitinol Compression Plating System	Biomedical Enterprises, Inc.	HRS	Class II	2015-01-16
K143006	GUARDIAN-SG Inflatable Bone Expander System	BM Korea Co., Ltd.	NDN	Class II	2015-01-16
K142980	Proficient (TM) Facet Screw Spine System	Spine Wave Inc	MRW	Unclassified	2015-01-16
K142922	SpyGlass DS Direct Visualization System	Boston Scientific Corporation	FBN	Class II	2015-01-16
K142897	P200DTx	Optos PLC.	MYC	Class II	2015-01-16
K142862	POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).	Careplus (M) Sdn Bhd	LZA	Class I	2015-01-16
K142599	PRECISE Trauma Nail System	Ellipse Technologies, Incorporated	HSB	Class II	2015-01-16
K142590	All Safe Huber Safety Infusion Set	Nexus Medical, LLC	FPA	Class II	2015-01-16
K142584	iMAR	Siemens Medical Solutions USA, Inc.	JAK	Class II	2015-01-16
K142583	LaborView LV1000	Obmedical Company	OSP	Class II	2015-01-16
K142283	Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2015-01-16
K142276	MCS Bone Graft	Biostructures, LLC	MQV	Class II	2015-01-16