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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2965 of 3529

510(k) clearances, page 2965 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852874	5F Electrode(lithotriptor)	Northgate Research, Inc.	FFK	Class II	1985-08-21
K852662	Gouda Frame for Stereotactic Neurosurgery	Neurosurgical Devices, Inc.	HAW	Class II	1985-08-21
K852546	Howmedica Cemented Flanged Acetabular Component Sy	Howmedica Corp.	JDI	Class II	1985-08-21
K852481	Uni Pak 500 Analyzer + Chemistry Reagent Item	Em Diagnostic Systems, Inc.	JJQ	Class I	1985-08-21
K852452	Rionet Hearing Aid Hb-71P	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-08-21
K852451	Rionet Hearing Aid Hb-34Ht	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-08-21
K852441	In Vitro Tests for Phosphatase & Blood Nitrogen	Clinical Data, Inc.	CJE	Class II	1985-08-21
K852324	Ureteral Dilator	American Edwards Laboratories	EZN	Class II	1985-08-21
K852169	Chloride Reagent	Horiba Instruments Incorporated	CHJ	Class II	1985-08-21
K852077	Versa Stim 380, Muscle Stimulator	Electro-Med Health Industries, Inc.	IPF	Class II	1985-08-21
K852023	Cesium 137 Source, Csm-4, Csm-11, Csm-41	Syncor Intl. Corp.	KXK	Class II	1985-08-21
K851646	Vibrector	Multicept, ApS.	LIL	Unclassified	1985-08-21
K851377	Diagnon Monocombo Vitam. B12[57co]/folate[125i] Ra	Diagnon Corp.	CDD	Class II	1985-08-21
K850852	Infrarax Device	Medicon Co., Ltd.	ILY	Class II	1985-08-21
K850815	Radioisotope Calibrator Model 34-062	Victoreen, Inc.	KPT	Class II	1985-08-21
K850433	Cesium 137 Endometrial Source	Syncor Intl. Corp.	KXK	Class II	1985-08-21
K844618	Bio-TENS	Bio-Research Associates, Inc.	GZJ	Class II	1985-08-21
K844595	Orthopedic Custom Surgical Kit	Xanmed Corp.	LXH	Class I	1985-08-21
K844448	Oms/gonvers Retinal Perforator	Optical Micro Systems, Inc.	HNM	Class I	1985-08-21
K853295	Emodren Exchangeable Plastic Bellows	Parexel Intl. Corp.	GCY	Class I	1985-08-20
K853276	Aso Slide Eiken	Syn-Kit, Inc.	GTQ	Class I	1985-08-20
K853199	Integrity Eye Drop Guide(modification)	Integrity Optics, Inc.			1985-08-20
K853185	Cuddle Cushion	The Cuddle Co.	LDQ		1985-08-20
K853070	Cooper Vision System VI u/s Module	CooperVision, Inc.	HQC	Class II	1985-08-20
K852774	Oculab Tonopen	Oculab, Inc.	HKY	Class II	1985-08-20
K852751	Tolvidine Red Unheated Serum Syphillis Card Test	Preco, Inc.	GMQ	Class II	1985-08-20
K852403	Auralite II	Aura Lens Products	HQG	Class I	1985-08-20
K852327	Beta Quik Stat	Pacific Biotech, Inc.	JHI	Class II	1985-08-20
K852208	Phaco-Bac Stop Filter Kit	Staar Surgical AG	HQC	Class II	1985-08-20
K852179	Ceramic Orthodonit Appliance	Gac Intl., Inc.	EJF	Class I	1985-08-20
K852122	Medilaser Mic Model Mel-445C, 15W	Mochida Pharmaceutical Co., Ltd	GEX	Class II	1985-08-20
K852121	Medilaser Mic Model Mel 440-C;30w	Mochida Pharmaceutical Co., Ltd	GEX	Class II	1985-08-20
K852075	Site-Malis Bipolar Coagulator Module	Valley Forge Scientific Corp.	HQO	Class II	1985-08-20
K851936	Staaxl-3 Small Incision System Tm, Phacofragmentat	Staar Surgical AG	HQE	Class II	1985-08-20
K851318	Guibor Microelectrolysis Unit 18	Galvanic Medical Instruments, Inc.	KCW	Class I	1985-08-20
K850945	Huntleigh Flowtron Air Hand Garment, Hg300	Huntleigh Technology, Inc.			1985-08-20
K850910	Huntleigh Flowtron Air, Ac400/2 Air	Huntleigh Technology, Inc.			1985-08-20
K844913	Cordis Pta Catheter-Percutaneous Catheter	Cordis US Corp.	LIT	Class II	1985-08-20
K853425	Cario-Pace Durapulse P101 Coated Pulse Generator	Cardio-Pace Medical, Inc.	DXY	Class III	1985-08-19
K853357	Uric Acid Reagent	Sigma Diagnostics, Inc.	KNK	Class I	1985-08-19
K853335	Blood Agar W/ampicillin, Bap W/ampicillin	Hardy Media	JSJ	Class I	1985-08-19
K853241	Hematology Stain Pack	Fisher Scientific Company L.L.C.	IAF	Class I	1985-08-19
K853238	Apl Mueller Hinton Agar	Apl Medical Supplies	JTZ	Class II	1985-08-19
K853237	Apl Martin Lewis Medium	Apl Medical Supplies	JTY	Class II	1985-08-19
K853236	Apl Tsa with 5% Sheep Blood	Apl Medical Supplies	KZI	Class I	1985-08-19
K853235	Apl Hektoen Enteric Agar	Apl Medical Supplies	JSI	Class I	1985-08-19
K853234	Apl Macconkey Agar	Apl Medical Supplies	JSI	Class I	1985-08-19
K853233	Apl Chocolate Agar	Apl Medical Supplies	KZI	Class I	1985-08-19
K853232	Apl Mannitol Salt Agar	Apl Medical Supplies	JSI	Class I	1985-08-19
K853231	Apl Sabouraud Dextrose Agar	Apl Medical Supplies	JSJ	Class I	1985-08-19