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 1424 of 3531

510(k) clearances, page 1424 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033370	Powered Wheelchair, Model Fr168w	Freerider, Corp.	ITI	Class II	2003-11-28
K032872	Micrus Microcoil System	Micrus Corp.	HCG	Class II	2003-11-28
K032865	Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	FTL	Class II	2003-11-28
K032716	Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)	Abbott Medical	CAH	Class II	2003-11-28
K032383	Multiclear Multiwavelength Targeted Phototherapy System	Curelight, Ltd.	GEX	Class II	2003-11-28
K031826	Triha +	Teknimed SAS	MQV	Class II	2003-11-28
K031374	Besmed Various Models of TENS, Be-550/Be-660	Besmed Health Business Corporation	GZJ	Class II	2003-11-28
K033561	Fuji Computed Radiography (Fcr) Velocity Image Reader	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2003-11-26
K033482	Microscan Synergies Plus Gram Negative Mic/combo Panels with Ampicillin (0.25-128 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2003-11-26
K033442	Reflection Constrained Liner	Smith & Nephew, Inc.	KWZ	Class II	2003-11-26
K033411	Synthes (USA) Sterile Adjustable Distal Radius Fixator (Adrf) with 4.0Mm/3.0mm Self-Drilling Schanz Screws	Synthes (USA) Products LLC	KTT	Class II	2003-11-26
K033386	Nxstage Pureflow Solution	NxStage Medical Inc	KPO	Class II	2003-11-26
K033368	Fossa Ureteral Open Lumen Stent	Fossa Medical, Inc.	EYB	Class II	2003-11-26
K033294	Hemosplit Xk, Hemosplit Xk Catheter, 16Fr X 42 Cm, Kit;16fr X 19 Cm, Kit with Microintroducer	C.R. Bard Inc	MSD	Class II	2003-11-26
K033292	Airis-Elite Rapid Body Coil, Model 554Hi-12	Igc-Medical Advances, Inc.	MOS	Class II	2003-11-26
K033281	Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-Net03 Software	GE Healthcare	MSX	Class II	2003-11-26
K033083	Borrelia Burgdorferi Igg/igm Elisa Test System	Trinity Biotech USA	LSR	Class II	2003-11-26
K033079	Chlamydia Igg Elisa Test System	Trinity Biotech USA	LJC	Class I	2003-11-26
K033070	Borrelia Burgdorferi Igm Elisa Test System	Trinity Biotech USA	LSR	Class II	2003-11-26
K033067	Pylori Igg	Trinity Biotech USA	LYR	Class I	2003-11-26
K033064	Mycoplasma Igg	Trinity Biotech USA	LON	Class II	2003-11-26
K033059	Herpes Group Igg	Trinity Biotech, PLC	LGC	Class II	2003-11-26
K033051	Legionella Pneumophila Igg/igm	Trinity Biotech USA	MJH	Class II	2003-11-26
K032774	Renova Internal Hex Implant System	Lifecore Biomedical LLC	DZE	Class II	2003-11-26
K032685	Cemstop Cement Restrictor	Teknimed SAS	LZN	Class II	2003-11-26
K032230	Rhythm Digital Electronic Stethoscope	Thinklabs, Inc.	DQD	Class II	2003-11-26
K032087	Keeler Wide Angle Ophthalmoscope Model 1130-P-5004	Keeler Instruments, Inc.	HLJ	Class II	2003-11-26
K031524	Gammamed Plus 3/24 Hdr Remote Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	2003-11-26
K031132	Consultiva Case Input Station, Model Cis-1	Eastman Kodak Company	LLZ	Class II	2003-11-26
K030319	Orthosphere Ceramic Spherical Implant	Wrightmedicaltechnologyinc	KWD	Class II	2003-11-26
K014200	Optimesh	Spineology, Inc.	EZX	Class II	2003-11-26
K033597	Atr 5000, Lc 5000, Implant System	Advanced Technology Research (A.T.R.) S.r.l.	EKX	Class I	2003-11-25
K033567	Models Hrk-63-8 Pms and Hrk-127-8 Knee Array Coils	Mri Devices Corp.	MOS	Class II	2003-11-25
K033504	Ge 0.35T Signa Ovation with Excite Mr System	General Electric Co.	LNH	Class II	2003-11-25
K033335	Lithostar Modularis with Shockwave System Cplus	Siemens Medical Solutions USA, Inc.	MMZ	Class II	2003-11-25
K033117	Grandio Flow	Voco GmbH	EBF	Class II	2003-11-25
K033015	Axiom Biolaser Lllt Series-3	Axiom USA., Inc.	NHN	Class II	2003-11-25
K033013	Mdification to Mediprime	Algotec Systems, Ltd.	LLZ	Class II	2003-11-25
K032537	Draeger Micro2+ and Masimo Minisat	Draeger Medical Systems, Inc.	DQA	Class II	2003-11-25
K031997	Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction System	Mallinckrodt Dar S.r.l.	BSY	Class I	2003-11-25
K031722	Jsa Reprocessed Compression Sleeve Devices	Jack Speer and Assoc., Inc.	JOW	Class II	2003-11-25
K031340	Siemens Infinity Modular Monitors, Models Sc 8000, Sc 7000 and Sc 9000Xl, with Scio	Siemens Medical Solutions USA, Inc.	MHX	Class II	2003-11-25
K031153	Monitor, Model Hsm-00200; Probe, Model Hsp-05065; Jacket, Model Hsj-05065	Arrow Intl., Inc.	DPW	Class II	2003-11-25
K030802	Caphosol	Inpharma A.S.	LFD	Unclassified	2003-11-25
K033554	Smart Offset Stapes Piston; Smart Isj Prosthesis	Gyrus Ent LLC	ETB	Class II	2003-11-24
K033548	Roche Diagnostics Urisys 1100 Urine Analyzer	Roche Diagnostics GmbH	KHE	Class II	2003-11-24
K033492	Modification to Mac 5000 ECG Analysis System	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-11-24
K032874	Hba Sperm-Hyaluronan Binding Assay	Biocoat, Inc.	POV	Class II	2003-11-24
K032811	Cedia Vancomycin Assay	Microgenics Corporation	LEH	Class II	2003-11-24
K032713	Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg	Boston Biomedica, Inc.	LSR	Class II	2003-11-24