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 2870 of 3529

510(k) clearances, page 2870 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863379	Dermatec Burn Pads	Dermatec, Inc.	NAD	Class I	1986-09-26
K863367	Formalens 2000	Cogentix Medical, Inc.	HQG	Class I	1986-09-26
K863329	Aca(r) C-Reactive Protein (Crp) Calibrator	E.I. Dupont de Nemours & Co., Inc.	DCK	Class II	1986-09-26
K863328	Aca(r) C-Reactive Protein (Crp) Analytical Test	E.I. Dupont de Nemours & Co., Inc.	DCK	Class II	1986-09-26
K863301	Demand Total Protein	Cooper Biomedical, Inc.	CEK	Class II	1986-09-26
K863259	Glucose Hk Procedure	Data Medical Associates, Inc.	CFR	Class II	1986-09-26
K863257	Ast/got Procedure	Data Medical Associates, Inc.	CIT	Class II	1986-09-26
K863256	Calcium Procedure	Data Medical Associates, Inc.	CIC	Class II	1986-09-26
K863254	Triglyceride (Trinder) Procedure	Data Medical Associates, Inc.	CDT	Class I	1986-09-26
K863251	Uric Acid Procedure	Data Medical Associates, Inc.	KNK	Class I	1986-09-26
K863095	Ace II (Tri-Level)	Medical Analysis Systems, Inc.	JIX	Class II	1986-09-26
K863075	Triglycerides-E	J. D. Assoc.	CDT	Class I	1986-09-26
K863059	Calciometer	J. D. Assoc.	CIA	Class II	1986-09-26
K863057	Bilirubin Total Direct	J. D. Assoc.	CIG	Class II	1986-09-26
K863010	Eurocart Sr-4, Eurocart M-IV, Isocart III	Sds Dental, Inc.	EIA	Class I	1986-09-26
K862617	Sensormedics Oxyshuttle(tm)	Sensor Medics Corp.	DQA	Class II	1986-09-26
K862596	Dr-2C (Modification)	General Devices	DSF	Class I	1986-09-26
K862498	Alkaline Phosphatase Test	King Diagnostics, Inc.	CJE	Class II	1986-09-26
K862430	Siegen Headphones	Siegen Corp.	GWJ	Class II	1986-09-26
K862377	Qmed Self Adhering Electrode	Qmed, Inc.	GXY	Class II	1986-09-26
K862312	Enzlipase, Enzymatic Lipase Kit	Nuclear Diagnostics, Inc.	CHI	Class I	1986-09-26
K862224	The Woog and the Woog D. Powered Toothbrushes	Xouth, Inc.	JEQ	Class I	1986-09-26
K861929	Pulmonary Function Test Laboratory, System 1070	Medical Graphics Corp.	BZM	Class II	1986-09-26
K861039	Omnivac (Vacuum Electrode System)	Physio Technology, Inc.	LIH	Class II	1986-09-26
K860680	Protex, Tahiti Condom	U. C. Import & Co.	HIS	Class II	1986-09-26
K863665	The Ultimate	Myocure, Inc.	HNN	Class I	1986-09-25
K863664	Ophthalmic Surgical Speculum	Myocure, Inc.	HNC	Class I	1986-09-25
K863645	Schulman Double Umbilical Cord Clamp No. 1000	United Medical Systems, Inc.	HFW	Class II	1986-09-25
K863616	Knife Maker	Surgipath Medical Industries, Inc.	IDL	Class I	1986-09-25
K863597	American Edwards 4.0 Mm Arthroscope	American Edwards Laboratories	HRX	Class II	1986-09-25
K863592	Disscap 80E, 110E, 140E, 160E	Hospal Medical Corp.	FJI	Class II	1986-09-25
K863545	Easy-Test Lactic Dehydrogenase (Ldh) # 67527/95	Em Diagnostic Systems, Inc.	CFJ	Class II	1986-09-25
K863514	Promedicor	Terra Marketing Assoc.	FMI	Class II	1986-09-25
K863511	Immobilizing Vacuum Matress (Ivm)	Omnium Services Partners, Inc.	FPP	Class I	1986-09-25
K863297	Modification's to Toray's B-2 Series	National Medical Care, Medical Products Div., Inc.	FJT	Class II	1986-09-25
K863235	Surgical Iop Monitor	Ameritek, Inc.	HKX	Class II	1986-09-25
K863188	Hpl Ria Kit	Biotecx Laboratories, Inc.	JMX	Class I	1986-09-25
K863157	Restodent Posterior	Lee Pharmaceuticals	EBF	Class II	1986-09-25
K863133	Prophy Care Paste	Imd, Inc.	EJR	Class I	1986-09-25
K863117	High Performance Cannabinoid Controls	Rapid Diagnostic Laboratories, Inc.	LAS	Class I	1986-09-25
K863088	Abbott Spectrum Phosphorus Reagent	Abbott Medical	CEO	Class I	1986-09-25
K863065	Hdl Cholesterol-E	J. D. Assoc.			1986-09-25
K863062	Cholesterol-E (Total)	J. D. Assoc.	CHH	Class I	1986-09-25
K863024	Seringa Triplice S.l.	Sds Dental, Inc.	ECB	Class I	1986-09-25
K863023	Cabinet II Auxiliary Unit	Sds Dental, Inc.	EIA	Class I	1986-09-25
K863018	Dentatus-S / L / Ls / (Gnatus)	Sds Dental, Inc.			1986-09-25
K863017	Isolax (Gnatus)/isolax Pedal/minilax	Sds Dental, Inc.			1986-09-25
K863009	Gnatus Articulator 4.300/4.300Gp 8.600 & Ortoflex	Sds Dental, Inc.	EJP	Class I	1986-09-25
K862968	Free T3 Radioimmunoassay Kit	Bioclinical Group	KHQ	Class II	1986-09-25
K862959	Merivaara Patient Trolley - Model #416	Global Medical Prods, Inc.	FPO	Class II	1986-09-25