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 1707 of 3531

510(k) clearances, page 1707 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993474	Deltapal, Alloy No. 5161	Metalor Dental USA Corp.	EJS	Class II	1999-12-02
K993457	Powderfree Latex Examination Gloves (Protein Label Claim) [50 Micrograms or Less]	Sri Johani Sdn. Bhd.	LYY	Class I	1999-12-02
K993271	Quality Latex Powdered Latex Medical Gloves with Protein Content Labeling Claim of 170 Microgram or Less	Quality Latex Corp. Sdn Bhd	LYY	Class I	1999-12-02
K993261	Talon Anchor Snap-Pak	Mitek Products	MBI	Class II	1999-12-02
K993215	Dermagrip Powdered Latex Surgical Glove, Sterile	Wrp Specialty Products Sdn. Bhd.	KGO	Class I	1999-12-02
K993214	Dermagrip Powder-Free Latex Surgical Glove, Sterile (Protein Content Labeling 50 Micrograms or Less)	Wrp Specialty Products Sdn. Bhd.	KGO	Class I	1999-12-02
K993127	Multi-Comfort Nitrile Examination Gloves, (Powder Free)	Glovesworld Industries Sdn. Bhd.	LZA	Class I	1999-12-02
K993104	Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova Co-Oximeter Thb Calibrator	Nova Biomedical Corporation	GLY	Class II	1999-12-02
K993102	Dried Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	LTT	Class II	1999-12-02
K993043	Ms-30 Femoral Stem	Sulzer Orthopedics, Inc.	LZO	Class II	1999-12-02
K992479	Ensite 3000 System	Endocardial Solutions, Inc.	DQK	Class II	1999-12-02
K991656	AED Arthroscope	National Advanced Endoscopy Devices, Inc.	HRX	Class II	1999-12-02
K991492	Lc Composite	Harry J. Bosworth Co.	EFB	Class I	1999-12-02
K984564	Ethyl Chloride Dispenser	Dukal Corp.	MLY	Unclassified	1999-12-02
K993890	Digital Blood Pressure Monitor, Model Ds-181	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1999-12-01
K993577	Cefotaxime/clavulanic, 30/10Ug, Bbl Sensi-Disc and Ceftazidime/clavulanic Acid, 30/10Ug, Bbl Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1999-12-01
K993569	Apr Metasul Acetabular Insert	Sulzermedica	KWA	Class III	1999-12-01
K993388	Allergen Immundocap Modelc5, C6, C73, E201, E213, F50, F51,f54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F	Pharmacia & Upjohn Company LLC	DHB	Class II	1999-12-01
K993317	Acon Hcg One Step Pregnancy Test Device (Urine)	Acon Laboratories, Inc.	JHI	Class II	1999-12-01
K993203	Acon One Step Pregnancy Test Strip (Urine)	Acon Laboratories, Inc.	JHI	Class II	1999-12-01
K993135	Implantable Clip for General Surgery	Applied Medical Resources Corp	FZP	Class II	1999-12-01
K992977	Hewlett Packard Multifunction Pediatric Defib Function, Model M3503a & M3504a	Hewlett-Packard Co.	MKJ	Class III	1999-12-01
K992384	Cpap/pro CPAP Interface	Stevenson Industries, Inc.	BZD	Class II	1999-12-01
K990398	Plateletworks	Array Medical, Inc.	JOZ	Class II	1999-12-01
K974503	Roche Amplicor Ct/ng Test for Neisseria Gonorrhoeae	Roche Molecular Systems Inc	LSL	Class II	1999-12-01
K993825	Para Tech Plus Retics	Streck Laboratories, Inc.	JCN	Class II	1999-11-30
K993642	Elecsys Parathyroid Hormone Calcheck	Roche Diagnostics GmbH	JJX	Class I	1999-11-30
K993546	Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3	Medical Analysis Systems, Inc.	JJY	Class I	1999-11-30
K993537	K-Assay Transferrin	Kamiya Biomedical Company, LLC	DDG	Class II	1999-11-30
K993496	Retic-Quinox	Hematronix, Inc.	JPK	Class II	1999-11-30
K993323	K-Assay Igm	Kamiya Biomedical Company, LLC	CFF	Class II	1999-11-30
K993310	Apolipoprotein Control Serum Chd, Model Ouph	Siemens Healthcare Diagnostics Inc.	JJY	Class I	1999-11-30
K992255	Ckhemo, Model Ckhemo Version 1.0	Csam, Inc.	FKP	Class II	1999-11-30
K992233	Apex Locator Bingo-1020	Dent Corp. Research & Development	LQY	Unclassified	1999-11-30
K993721	Urostym Biofeedback and Stimulation Anal/rectal Probes	Laborie Medical Tech Corp.	KPI	Class II	1999-11-29
K993481	K-Assay C4	Kamiya Biomedical Company, LLC	DBI	Class II	1999-11-29
K993249	Opc Low Wear Opaque Porcelain	Jeneric/Pentron, Inc.	EIH	Class II	1999-11-29
K993013	Sure Bond	Miradent Distributing Co., LLC	KLE	Class II	1999-11-29
K992948	Mac-Lab System	General Electric Medical Systems Information Techn	DQK	Class II	1999-11-29
K992862	Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	LYZ	Class I	1999-11-29
K981485	Hybrid Capture II Gc-Id	Qiagen	LSL	Class II	1999-11-29
K993646	S.m.a.r.t. .018 Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	1999-11-28
K993780	Qsc-300 Shoulder Array Coils	Mri Devices Corp.	MOS	Class II	1999-11-26
K993765	Quantitative Analysis of Left Ventricular Angiograms (Qlv)	Medis Medical Imaging Systems, B.V.	IZI	Class II	1999-11-26
K993763	Quantitative Analysis of Coronary Angiograms (Qca)	Medis Medical Imaging Systems, B.V.	IZI	Class II	1999-11-26
K993740	Mamex	Medical Systems Group	IZH	Class II	1999-11-26
K993728	Medrad Envision CT Injector System	Medrad, Inc.	DXT	Class II	1999-11-26
K993719	Kac-300 Knee Array Coil	Mri Devices Corp.	MOS	Class II	1999-11-26
K993606	K-Assay Apo A1/b Calibrator Set	Kamiya Biomedical Company, LLC	JIX	Class II	1999-11-26
K993589	Varelisa Rnp Antibodies	Pharmacia & Upjohn Company LLC	LKO	Class II	1999-11-26