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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3406 of 3526

510(k) clearances, page 3406 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790794	Siemens Cardiostat 701	Elmed, Inc.	DPS	Class II	1979-05-31
K790672	Aspergillus Fumigatus, Aspergillus Flavu	Diagnostica, Inc.	JWT	Class I	1979-05-31
K790671	Dermatophytin O	Diagnostica, Inc.	JXB	Class I	1979-05-31
K790601	Dental Handpiece	Venture Technology, Inc.	EFB	Class I	1979-05-31
K790513	Hla-2000	Bdt Ent.	DRM	Class II	1979-05-31
K790860	Rt-Hood	Plastics Supplies & Products	FOG	Class I	1979-05-29
K790856	Proctoscope #501	C. Intl.	GCF	Class II	1979-05-29
K790689	Revised Battery Charger	Vickers America Medical Corp.	FPL	Class II	1979-05-29
K790582	Intravascular Administration Set	Y	FPA	Class II	1979-05-29
K790532	Fever Tester	Maddak, Inc.	KPD	Class II	1979-05-29
K790085	Kager Trapdust	Kager Intl.	LDQ		1979-05-29
K790868	Generator, 16 Series, Modified Top Cap	Telectronics, Inc.	DXY	Class III	1979-05-25
K790847	Egs Model 300	Alfred V. Greco	IPF	Class II	1979-05-25
K790810	Disposa-Cuf	Crest Medical Equipment	DXQ	Class II	1979-05-25
K790804	Purge Line Unit	Surgikos, Inc.	DTL	Class II	1979-05-25
K790790	Pisces-Selector X	Medtronic, Inc.	GZB	Class II	1979-05-25
K790766	Medtronic Models 6907/6901	Medtronic, Inc.	DTB	Class III	1979-05-25
K790686	Emit Cfa Thyroxine Assay	Syva Co.	KLI	Class II	1979-05-25
K790638	Accutron Pollution Reducer	Parker Laboratories, Inc.	BSJ	Class I	1979-05-25
K790580	Ria Kit, Prostatic Acid	Monitor Science Corp.	JFH	Class II	1979-05-25
K790460	Txocell-Iha Reagent System	Calbiochem-Behring Corp.	GMM	Class II	1979-05-25
K790295	Test Kit, Iif-Ama	Medica Corp.	DBM	Class II	1979-05-25
K790105	Terumo Imugard	Terumo America, Inc.	GKT	Class II	1979-05-24
K790941	D.t.t. Lock Screw Inserter	Depuy, Inc.	KWQ	Class II	1979-05-23
K790899	Bactec	BD Becton Dickinson Vacutainer Systems Preanalytic	KLP	Class II	1979-05-23
K790877	Biovac: Lfa Laser Fume (Smoke) Evacuatio	Stackhouse Assoc.	JDY	Class I	1979-05-23
K790872	Enteric Tube Guide	Biosearch Medical Products, Inc.	FZX	Class I	1979-05-23
K790776	Dade Low Ionic Strength Soluition (Liss)	Dade, Baxter Travenol Diagnostics, Inc.	KSG	Class II	1979-05-23
K790768	Wako Cholesterol Test	Wako Intl., Inc.	CHH	Class I	1979-05-23
K790767	Immu-Tek Automatic Centrifuge	Dade, Baxter Travenol Diagnostics, Inc.	KSN	Class II	1979-05-23
K790760	Reagent System #350Hdl, Sigma Procedure	Sigma Chemical Co.	CHH	Class I	1979-05-23
K790724	Enzymatic Determination	Sigma Chemical Co.	CHH	Class I	1979-05-23
K790679	Estradiol Ria Kit	Serono Laboratories, Inc.	CHP	Class I	1979-05-23
K790668	Venous Pressure Monitor, Mf 35 Lf	Deco Medical, Inc.	KRK	Class II	1979-05-23
K790646	Helena Quiplate System	Helena Laboratories, Corp.	JZQ	Class I	1979-05-23
K790643	Centrifichem Filter Calibration Set	Union Carbide Corp.	JIW	Class II	1979-05-23
K790570	Stimulator, Nic-106 Visual	Nicolet Biomedical Instruments	GWE	Class II	1979-05-23
K790542	Electrodes, Staoderm Sterile	Staodynamics, Inc.	GXY	Class II	1979-05-23
K790524	Data-Zyme Acia Phosphatase Procedure	Data Medical Associates, Inc.	CKE	Class II	1979-05-23
K790397	Concep-7-B-Hcg	Leeco Diagnostics, Inc.	JHI	Class II	1979-05-23
K790360	Quantazyme Toxoplasma	Bio-Rad	GLZ	Class II	1979-05-22
K790934	Oxygen Barb M-552	Mem Medical, Inc.	BYG	Class I	1979-05-21
K790933	Mouthpiece M-187	Mem Medical, Inc.	BYP	Class I	1979-05-21
K790932	Aerosol Mouthpiece No. M-091	Mem Medical, Inc.	BYP	Class I	1979-05-21
K790931	Corrugated Tube with Mouthpiece	Mem Medical, Inc.	BYP	Class I	1979-05-21
K790929	Drainage Bag	Mem Medical, Inc.	BYH	Class I	1979-05-21
K790928	3-Way T 22Mm Male	Mem Medical, Inc.	BYX	Class I	1979-05-21
K790927	Oxygenerator No. M-049	Mem Medical, Inc.	BTR	Class II	1979-05-21
K790926	Nebulizer with Mouthpiece and Tee	Mem Medical, Inc.	CAF	Class II	1979-05-21
K790925	Nebulizer with 4-Way T No M-174	Mem Medical, Inc.	CAF	Class II	1979-05-21