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 2026-11-02, 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 2469 of 3531

510(k) clearances, page 2469 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910011	Post Surgical Kit/post Biopsy Kit	Dermatological Research Laboratories, Inc.	MCY	Class II	1991-03-27
K905646	Omegaport Subcutaneously Implanted Drug Delivery	Norfolk Medical	LJT	Class II	1991-03-27
K905448	Thora-Klex Chest Drainage Unit	Davol, Inc.	GCX	Class II	1991-03-27
K905123	G-Tube Dressing Change Tray	Continental Medical Laboratories, Inc.	MCY	Class II	1991-03-27
K904800	Sif-Sw	Olympus Corp.	FDA	Class II	1991-03-27
K904799	Chf-B20 Choledochoscope	Olympus Corp.	FBN	Class II	1991-03-27
K904514	Strung Telfa Non-Adherent Sponge	American Silk Sutures, Inc.	HBA	Class II	1991-03-27
K904189	Ciba Corning Magic Lite Chlamydia Immunoassay	Ciba Corning Diagnostics Corp.	LJC	Class I	1991-03-27
K903499	Mini-Micron Circuit	Medical Industries America, Inc.	CAF	Class II	1991-03-27
K903161	Mc II (Tm), Model 7200S	Medical Devices Inc.	GZJ	Class II	1991-03-27
K901157	Mp4, Mp4si, It4 Incubators	Mediprema	FMZ	Class II	1991-03-27
K911152	Quad-Link Retractable Mount	Tarsys Engineering, Inc.	ITI	Class II	1991-03-26
K910988	Osteonics Ion Implanted Femoral Bearing Series	Osteonics Corp.	JDI	Class II	1991-03-26
K910755	Premier-Total(tm) Hip with Calcitite(r) Coating	Intermedics Orthopedics	MEH	Class II	1991-03-26
K910464	Gore-Tex(r) Expanded PTFE Surgical Membrane	W. L. Gore & Associates, Inc.	DXZ	Class II	1991-03-26
K910019	Novametrix Model 1265 End Tidal Carbon Dioxide Mon	Novametrix Medical Systems, Inc.	CCK	Class II	1991-03-26
K905786	Global Total Shoulder	Depuy, Inc.	KWT	Class II	1991-03-26
K905785	Arthro-Fms-3/Irrigation Sets (Various)	Orthoconcept, Inc.	HRX	Class II	1991-03-26
K905599	Jetta Jr. Hydro Massage	Jetta Products, Inc.	ILJ	Class II	1991-03-26
K904902	Sma 26 Transducer	Parexel Intl. Corp.	ITX	Class II	1991-03-26
K904901	L11, L12 Linear and C11, C12 Convex Array Transduc	Parexel Intl. Corp.	ITX	Class II	1991-03-26
K904766	Devilbiss Model 7352 Series	Devilbiss Health Care, Inc.	BZD	Class II	1991-03-26
K903493	Namic Contrast Savings Delivery System	North American Instrument Corp.	IZI	Class II	1991-03-26
K910498	Magnetom 42 Sp and 63 Sp	Siemens Medical Solutions USA, Inc.	LNH	Class II	1991-03-25
K910220	Magnetic Resonance Device Accessory, Sm Parts Coil	Toshiba America Mri, Inc.	LNH	Class II	1991-03-25
K905416	Vessel Dilator	The R Group	DRE	Class II	1991-03-25
K905412	Es/ultra Display and Processing Station	Toshiba America Medical Systems, In.C	IYX	Class I	1991-03-25
K904410	Meadox(r) Surgimed Olbert Cath Syst/no Profile(tm)	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1991-03-25
K903848	Diagnostic Intrascular Catheter	Applied Vascular Devices, Inc.	DQO	Class II	1991-03-25
K902185	Dynamic Spectral Phonocardiograph	Reeves Scientific, Inc.	DQC	Class I	1991-03-25
K896520	Owens Catheter	Boston Scientific Corporation	LIT	Class II	1991-03-25
K910071	Porta Gas Compressed Gas Cylinder Cart	Sen Tech Medical Corp.	GET	Class I	1991-03-22
K905801	Cemax Sparcstation Imaging Software and Workstatio	Cemax, Inc.	LLZ	Class II	1991-03-22
K905527	Needlestick Protective Glove	Medev Corp.	LZC	Class I	1991-03-22
K905384	David Simmonds Anesthesia Extension Tubes	Sparta Surgical Corp.	FMF	Class II	1991-03-22
K905054	Ciba Corning Model 980 Magic Lite Allergy Manager	Ciba Corning Diagnostics Corp.	DHB	Class II	1991-03-22
K904019	Quantum 2000 Angiodynograph Ultrasound System	Quantum Medical Systems, Inc.	IYO	Class II	1991-03-22
K901763	Nature's Cradle(tm)	Infant Advantage, Inc.	FMS	Class II	1991-03-22
K900105	Cobe Spectra Blood Component Separator Therapeutic	Cobe Laboratories, Inc.	LKN	Unclassified	1991-03-22
K911096	Dahlberg Model Lz Bte Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-03-21
K911081	Latex Patient Examination Gloves	Medical Device Inspection Company	LYY	Class I	1991-03-21
K911064	Dahlberg Model Lg Bte Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-03-21
K911063	Dahlberg Model Lu Bte Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-03-21
K910979	Dahlberg Model Lt Bte Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-03-21
K910974	Mcconnell Shoulder Brace	Mcconnell Orthopedic	IQI	Class I	1991-03-21
K910809	Dahlberg Model Lb Behind-the-Ear Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1991-03-21
K910799	Landmark Venous Access Device	Menlo Care, Inc.	FOZ	Class II	1991-03-21
K910793	Reconstitution Device	Baxter Healthcare Corporation	LHI	Class II	1991-03-21
K910747	Fortress Aeroedge 3-Wheel Manual Racing Wheelchair	Fortress Litestyle	IOR	Class I	1991-03-21
K910739	Target Amphetamine/methamphetamine-R (Reader Meth)	V-Tech, Inc.	DKZ	Class II	1991-03-21