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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2574 of 3530

510(k) clearances, page 2574 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896926	Directigen 1-2-3 Infectious Mononucleosis Controls	Ortho-Clinical Diagnostics, Inc.	KTN	Class II	1990-01-26
K896897	Ventlab Anesthesia Circuit Ac 6000	Salter Labs	CAI	Class I	1990-01-26
K896809	Medtronic Spectrax Sxt Model 8423M Pulse Generator	Medtronic, Inc.	DXY	Class III	1990-01-26
K896528	Sfa Module	Life Sciences Manufacturing, Inc.	DXG	Class II	1990-01-26
K896506	Porges Endoscopic Dormia Extractors, Dormiatriptor	Porges Corp.	FGE	Class II	1990-01-26
K896504	Porges 2-Way Balloon Extraction Catheter	Porges Corp.	FGE	Class II	1990-01-26
K896424	Porges Sclerotherapy Needles	Porges Corp.	FBK	Class II	1990-01-26
K896304	Olympia Faceplate Module	Olympia Instruments, Inc.	LRB	Class I	1990-01-26
K896298	Jedmed S Chair	JEDMED Instrument Company	ETF	Class I	1990-01-26
K896297	Flexible Nasopharyngoscope	JEDMED Instrument Company	EOB	Class II	1990-01-26
K896274	Tympanoscope	JEDMED Instrument Company	ERA	Class I	1990-01-26
K896273	Systema ENT Cabinet	JEDMED Instrument Company	ETF	Class I	1990-01-26
K896249	Bandtite Glass Ionomer Cement	American Orthodontics	EMA	Class II	1990-01-26
K896064	Ambulatory Cardiac Monitor	Monitech, Inc.	DPS	Class II	1990-01-26
K895970	Powder-Free Latex Examination Gloves	Usamal Latex Products Sdn Bhd	LYY	Class I	1990-01-26
K895906	Abuscreen Ontrak for Phencyclidine (Pcp)	Roche Diagnostic Systems, Inc.	LCM	Unclassified	1990-01-26
K895858	Clp Elevated Lipid Control	Creative Laboratory Products, Inc.	LYY	Class I	1990-01-26
K895795	Hpd Tubing Connectors	Hpd Medical, Inc.	DTL	Class II	1990-01-26
K895732	Jobst Athrombic Pump(r) System 2000	Jobst Institute, Inc.	JOW	Class II	1990-01-26
K895533	Life Defense Plus(tm), Defibrillator/monitor/pacer	Matrix Medica, Inc.	LDD	Class II	1990-01-26
K895525	Matrx Battery Charger/defibrillator Tester	Matrix Medica, Inc.	DRL	Class II	1990-01-26
K895266	Ambulatory (Holter) Recording System - Modified	Biosensor Corp.	DSI	Class II	1990-01-26
K895111	Type 9541 Recorder, Paper Chart	S & W Medico Teknik	DSF	Class I	1990-01-26
K894922	Wr3500 and Wr3600 Series Recorders	Western Graphtec	DSF	Class I	1990-01-26
K894899	Expansion of the Cordis Pta Dilatation Catheter	Cordis US Corp.	LIT	Class II	1990-01-26
K894686	Powder-Free Vinyl Examination Gloves	Dynarex Corp.	LYY	Class I	1990-01-26
K894155	Sleepscan	Biologic Systems Corp.	OLZ	Class II	1990-01-26
K892619	Latechnics Latex Examination Gloves	Ssangyong Corp. (M) Sdn. Bhd.	LYY	Class I	1990-01-26
K891662	Patient Examination Gloves (Latex)	Darchet (USA), Inc.	LYY	Class I	1990-01-26
K882955	Supermon Neonatal Non-Invasive Blood Press. 7283	Kontron Instruments, Inc.	DXN	Class II	1990-01-26
K900150	Hch 9165, 9165 S, 9166, Hfh, Hfh-T Heat Moisture	Icor AB	BYD	Class I	1990-01-25
K900133	Factor II Deficient Plasma	Medical Diagnostic Technologies, Inc.	GJT	Class II	1990-01-25
K900049	Aptt-Ea Reagent, an Ellagic Acid Activated Reagent	Medical Diagnostic Technologies, Inc.	GFO	Class II	1990-01-25
K900019	Rocket Reference Plasma, Cat No. 5188	Helena Laboratories, Corp.	GGN	Class II	1990-01-25
K897048	Clean Hand-Vcl Glove Dispenser	Safety Today, Inc.	LYY	Class I	1990-01-25
K896922	Raichem Tm Hemoglobin Reagent	Reagents Applications, Inc.	GKK	Class II	1990-01-25
K896921	Raichem Tm Hemoglobin Calibrator	Reagents Applications, Inc.	KRZ	Class II	1990-01-25
K896872	Latex Non-Powdered Examination Gloves	Thaisan Industries Co., Ltd.	LYY	Class I	1990-01-25
K896474	Resubmitted Fecatwin Sensitive - Feca-Eia	Labsystems, Inc.	KHE	Class II	1990-01-25
K900175	4/1 Armboard	Infection Control Products, Inc.	BTX	Class I	1990-01-24
K900160	Adaptor: Kaps Cine to Moeller Beamsplitter	JEDMED Instrument Company	KQM	Class I	1990-01-24
K900072	Immunodot Autoimmunity Screening Panel 2	General Biometrics, Inc.	LJM	Class II	1990-01-24
K896976	Modified Sepacell R-500 and R-500A Blood Filters	Asahi Kasei Medical MT Corp. Oita Works	CAK	Class II	1990-01-24
K896906	Latexindo Latex Examination Gloves	P.T. Latexindo Sejahtera	LYY	Class I	1990-01-24
K896847	Sharplan 1030 Sealed CO2 Surgical Laser System	Sharplan Lasers, Inc.	GEX	Class II	1990-01-24
K896722	Piston Syringe	Safe Tech Medical Products, Inc.	FMF	Class II	1990-01-24
K896690	Modified Angiographic Catheter	Best Vascular, Inc.	DQO	Class II	1990-01-24
K896664	Modified Sepacell Pl-Series Leukocyte Removal Filt	Asahi Kasei Medical MT Corp. Oita Works	CAK	Class II	1990-01-24
K896427	Spacelabs' Model 90514, Multigas Analyzer	Spacelabs, Inc.	CCL	Class II	1990-01-24
K896352	Model Ec4542g Miniature	Pace Medical	DTE	Class II	1990-01-24