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 2981 of 3529

510(k) clearances, page 2981 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851401	Venuos Reservoir Bag Bmr-1900	American Bentley	DTN	Class II	1985-06-25
K851376	Venous Reservoir Bag Bmr-1600	American Bentley	DTN	Class II	1985-06-25
K850938	Cholesterol	Dilab, Inc.	CGO	Class I	1985-06-25
K850936	Total Proteins	Dilab, Inc.	CEK	Class II	1985-06-25
K850934	Phosphorus	Dilab, Inc.	CEO	Class I	1985-06-25
K850933	Uric Acid	Dilab, Inc.	CDH	Class I	1985-06-25
K850932	Creatinine	Dilab, Inc.	CGX	Class II	1985-06-25
K850907	Ck 1-3, Ld 1-5 Isoenzyme Control Human Levels 1/2/	Cala Diagnostics	JJT	Class I	1985-06-25
K850851	G5 Apparatus T, K1, K3 & the President Model's	Physio Technology, Inc.	ISA	Class I	1985-06-25
K850727	Bhcg-Roche Eia	Hoffmann-La Roche, Inc.	JHI	Class II	1985-06-25
K844894	Photometer Various One for Microtiterplates	Slt Labinstruments, Inc.	JJQ	Class I	1985-06-25
K852515	Accessory Ventillary(breathing) Frequency Monitor	Alternative Design Systems, Inc.	BZQ	Class II	1985-06-24
K852308	St-460 Spiro Analyzer Spirometer	Futuremed Div. of Future Impex Corp.	BZG	Class II	1985-06-24
K852298	TENS-Aid Sterile Electrodes for Post-Op TENS	Staodynamics, Inc.	GXY	Class II	1985-06-24
K852209	Devo/mc29 Oxygen Concentrator Mc29d	The Devilbiss Co.	CAW	Class II	1985-06-24
K852049	Medical Toilet Seat	Pedro Aleman	ILS	Class I	1985-06-24
K851840	Stomahesive Skin Barrier Sterile	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1985-06-24
K851682	Safeseal Reusable Urinal System	Dbt Medical, Ltd.	EXJ	Class I	1985-06-24
K851652	Papillotome	Microvasive	KNS	Class II	1985-06-24
K851169	Electra 800 Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	KQG	Class II	1985-06-24
K851152	Mc-4000 Surgical Instruments Cardiovascular	Cryomedics LLC	DWS	Class I	1985-06-24
K851057	Laserflo Blood Perfusion Monitor 403	Tsi, Inc.	DPW	Class II	1985-06-24
K850504	Corometrics 500 Infant Monitor	GE Medical Systems Information Technologies, Inc.	BZQ	Class II	1985-06-24
K844895	Oms Silicone Oil Injector	Optical Micro Systems, Inc.	LWL	Class III	1985-06-24
K852290	Privatan Home Tanning Center	Privatan, Inc.	FTC	Class II	1985-06-21
K852033	Ss-A(ro) & Ss-B(la) Antibody Assay	Meloy Laboratories, Inc.	DHN	Class II	1985-06-21
K851912	Laser Prealbumin Test	Behring Diagnostics, Inc.	JZJ	Class I	1985-06-21
K851839	Manan Madayag Ptc Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-06-21
K851838	Manan Chiba Ptc Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-06-21
K851836	Manan Menghini Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-06-21
K851622	Timentin 85 Mcg. Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1985-06-21
K851420	Multicor S, Models 330A/331a	Cordis US Corp.	DXY	Class III	1985-06-21
K851403	Ventrezyme Allergen Data Reduction System	Ventrex Laboratories, Inc.	JQW	Class I	1985-06-21
K851378	Virtran Viral Tranporter	Diagnon Corp.	LIO	Class I	1985-06-21
K851275	Gibco Mycotect 189-5670	Gibco Laboratories Life Technologies, Inc.	KIW	Class I	1985-06-21
K851218	Penox Lift Chair	Penox Technologies, Inc.	INO	Class II	1985-06-21
K851033	Syncortech Chlamydia Direct Speciman Kit	Syncor Intl. Corp.	LJP	Class I	1985-06-21
K851007	Gravity Traction Table	William F. Trinkaus	INQ	Class I	1985-06-21
K850664	Endo-Tube	Biosearch Medical Products, Inc.	KNT	Class II	1985-06-21
K845037	Percutaneous Angiographic Needles	Mallinckrodt Critical Care	DYB	Class II	1985-06-21
K844593	Cardiovascular Custom Surgical Kit	Xanmed Corp.	DYB	Class II	1985-06-21
K844068	Trochanter Cable Grip System	Howmedica Corp.	KTT	Class II	1985-06-21
K843077	Elisa for Herpes Simplex Virus	Scientific Research	LGC	Class II	1985-06-21
K834059	Fukuda Denshi Eh-11	Fukuda Denshi USA, Inc.	DXG	Class II	1985-06-21
K852378	Light Reflection Rheography	Hemodynamics, Inc.	DSB	Class II	1985-06-20
K852345	Sea-Long Neckseal & Hood	Safety Sea Systems, Inc.	BYL	Class I	1985-06-20
K852300	Inox IV Stand	Broadwest Corp.	FOX	Class I	1985-06-20
K852275	Vascular Tech # 100123 Polarographic Oxgyen Sensor	Vascular Technology Incorporated	CCL	Class II	1985-06-20
K852196	Zionomer Cement	Den-Mat Corp.	EMA	Class II	1985-06-20
K851971	Series 7000/Holter Recorder	Pfizer Inc	DSH	Class II	1985-06-20