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 2887 of 3529

510(k) clearances, page 2887 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853332	Hdc Chemo-Port (Vascular)	Hdc Corp.	LJT	Class II	1986-07-17
K862681	Ultramark 1 Ultrasound System	Advanced Technology Laboratories, Inc.	IYO	Class II	1986-07-16
K862554	Immpulse Phenytoin Assay Reagent	Sclavo, Inc.	LGR	Class II	1986-07-16
K862545	Hearing Aid (All-in-Ear)	Vibrasonic, Inc.	ESD	Class I	1986-07-16
K862528	Immpulse Phenobarbital Assay Reagents	Sclavo, Inc.	LGQ	Class II	1986-07-16
K862507	Fast Cholesterol (Total Cholesterol Test)	Sclavo, Inc.	CHH	Class I	1986-07-16
K862487	Ms-139 Electronic Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1986-07-16
K862486	Ms-159 Electronic Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1986-07-16
K862485	Ms-179 Electronic Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1986-07-16
K862457	Lynx El Microscopy Tissue Processor	Australian Biomedical Corporation, Ltd.	IDZ	Class I	1986-07-16
K862438	Surgical Drapes and Drape Accessories	Avery Intl.	KKX	Class II	1986-07-16
K862326	Porous Coated Hip Femoral Prosthesis	Johnson & Johnson Professionals, Inc.	LPH	Class II	1986-07-16
K862222	Inearset Ies Hearing Aid	Inearset, Inc.	ESD	Class I	1986-07-16
K862140	Microdilution Panels	American Micro Scan	JWY	Class II	1986-07-16
K862139	Imtech Fixation Systems	Imtech Corp.	JEY	Class II	1986-07-16
K862116	Stockert-Shiley Double Head Pump Module	Shiley, Inc.	DWB	Class II	1986-07-16
K862086	In Situ Ear Gain Audio Test Stat Type 2118/Wh 1823	A/S Bruel & Kjaer	ETW	Class II	1986-07-16
K862029	Siemens Radiotherm 706, Microwave Therapy Unit	Elmed, Inc.	IOA	Class II	1986-07-16
K861714	Stockert-Shiley Multiflow Roller Pump Module	Shiley, Inc.	DWB	Class II	1986-07-16
K861379	Monabrite Respir Syncytial Virus(rsv) Test Kit	Serono Diagnostics, Inc.	LKT	Class I	1986-07-16
K861238	Angiomedics Cath Sheath Introduc W/hemostasis Valv	Angiomedics, Inc.	DYB	Class II	1986-07-16
K860585	Astra T2, T3, T4 & T6 Multiprogram Pulse Generator	Cardiac Pacemakers, Inc.	DXY	Class III	1986-07-16
K860498	Gen-Probe Legionella Rapid Diagnostic System	Hologic, Inc.	LQH	Class II	1986-07-16
K862576	Ps2 Brand Facial Symmetry Guide (Lee Design)	Professional Services for Surgeons, Ltd.	FTY	Class I	1986-07-15
K862563	Tracheostomy Cleansing Solution	Clinipad Corp.	EPE	Class I	1986-07-15
K862559	Carbostat, CO2 Analyzer	Elm Street Designs	CCK	Class II	1986-07-15
K862549	Arterial Blood Filter Holder Model No. Af-He	American Bentley	KRI	Class I	1986-07-15
K862543	Dynex Co2/2000, CO2 Analyzer	Analytical Products, Inc.	CCK	Class II	1986-07-15
K862529	Hall Sterile Bur	Hall Surgical, Division of Zimmer, Inc.	HTT	Class I	1986-07-15
K862405	Runaround	Everest & Jennings, Inc.	ITI	Class II	1986-07-15
K862314	Hip Continuous Passive Motion Machine	Richards Medical Co., Inc.	BXB	Class I	1986-07-15
K862147	Bomdal Standard Lift	Bomdal Medical Equipment, Inc.	FNG	Class II	1986-07-15
K862146	Bomdal Travelmaster Lift	Bomdal Medical Equipment, Inc.	FNG	Class II	1986-07-15
K862096	Static Strength Tester	Lowcountry Orthopaedic Assoc., P.A.	IKK	Class II	1986-07-15
K861977	Biomedical Dynamics Disposable Pressure Infusor	Biomedical Dynamics, Inc.	KZD	Class I	1986-07-15
K861830	Empi Model Gls 450, TENS	Empi	GZJ	Class II	1986-07-15
K861781	Delivery Room Warmer	Air-Shields, Inc.	FMT	Class II	1986-07-15
K861618	Travasorb Feeding Tubes - (2L8014) and (2L8024)	Travenol Laboratories, S.A.	KNT	Class II	1986-07-15
K861608	Unicare Breast Shells	Unicare Medical Products, Inc.	HFS	Class I	1986-07-15
K860528	The Keymed Fiberscope Sterilization Case	Keymed, Inc.	KCT	Class II	1986-07-15
K855096	Siemens Sirecust Models 403P,403-2P & 403N	Analogic Corp.	DPS	Class II	1986-07-15
K853771	Pinnacle Multi-Programmable Pacing Sys	Cardio-Pace Medical, Inc.	DXY	Class III	1986-07-15
K862575	Universal Stand for Film Changer	Canon Medical Components U.S.A., Inc.	KPX	Class II	1986-07-14
K862497	Microtek Septal Button	Microtek Medical LLC	LFB	Unclassified	1986-07-14
K862496	Microtek Intranasal Splint	Microtek Medical LLC	EPP	Class I	1986-07-14
K862178	Isopure Lc System	Revvity Health Sciences, Inc.	LDM	Class I	1986-07-14
K862171	Mp-500 Electronic Nebulizer	The Timeter Group	KFZ	Class I	1986-07-14
K862136	Modified Whiteside Posterior Stabilized Total Knee	Dow Corning Wright	HSX	Class II	1986-07-14
K862131	Saltzman Ear(tm) Endotracheal Ascultation Receptor	K & S Medicorp	BZT	Class II	1986-07-14
K862031	Hawkins Mini-E.b.a.	Pb Sales C/O Geller & Bozeman	IPF	Class II	1986-07-14