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 1772 of 3531

510(k) clearances, page 1772 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984522	Modification of Tsrh Spinal System	Danek Medical, Inc.	MNI	Class II	1999-01-06
K983937	Dual Vial Creatinine Reagent	Intersect Systems, Inc.	CGX	Class II	1999-01-06
K983898	Bioclot Apc Sensitivity	Biopool Intl., Inc.	GGP	Class II	1999-01-06
K983347	Osseotite Dental Implants	ZimVie US Corp LLC	DZE	Class II	1999-01-06
K982988	Precision UV (Vasurfilcon a)	Wesley Jessen Corp.	LPL	Class II	1999-01-06
K982928	Npt7 Series Ph/blood Gas and Co-Oximetry System	Radiometer America, Inc	CHL	Class II	1999-01-06
K983565	System U3 for Nitrofurantoin	Ab Biodisk	JWY	Class II	1999-01-05
K983679	Statim 5000 Cassette Autoclave	Scican Ltd.	FLE	Class II	1999-01-04
K981376	Hewlett-Packard M1205a Viridia 24 CT	Hewlett-Packard Co.	DSI	Class II	1999-01-04
K984458	Depuy Ace Spider Plate	Depuy Ace Medical Co.	HRS	Class II	1998-12-31
K983770	'Rapid Drug Screen' 9-Panel	American Bio Medica Corp.	DKZ	Class II	1998-12-31
K983529	Instatrak 3000	Visualization Technology, Inc.	LLZ	Class II	1998-12-31
K981680	Ultrapure Water Treatment System for Hemodialysis	Dayton Water Systems	FIP	Class II	1998-12-31
K984431	Ultima Airflow Pressure Sensor	Braebon Medical Corp.	BZQ	Class II	1998-12-30
K984414	Xre Collimator with Spectral Filter	Trex Medical Corp.	IZW	Class II	1998-12-30
K984401	Neuromag Vectorview	Philips North America LLC	OLX	Class II	1998-12-30
K984378	Depuy Acromed Moss Spinal System	Depuy, Inc.	MNI	Class II	1998-12-30
K984342	Anterior Cervical Plating System	United States Surgical, A Division of Tyco Healthc	KWQ	Class II	1998-12-30
K983976	Metagen Activelock Wire Cerclage System	Metagen, LLC	JDQ	Class II	1998-12-30
K983873	Syntec-Taichung Non-Sterile Dhs/dcs Plate System	Syntec Scientific Corp.	KTT	Class II	1998-12-30
K983761	Aaron Electrosurgical Handcontrol Pencil, Model Esp5	Apyx Medical Corporation	GEI	Class II	1998-12-30
K983747	Synchron Systems Dat Low and High Urine Calibrators II	Siemens Healthcare Diagnostics Inc.	DKB	Class II	1998-12-30
K983622	Bodyform Thoraco-Lumbar Fixation System	Theken Surgical,Llc	KWQ	Class II	1998-12-30
K983571	System U3 for Tetracycline	Ab Biodisk	JWY	Class II	1998-12-30
K983519	Comfeel Seasorb Dressing	MEDLINE INDUSTRIES, LP - Northfield	KMF	Class I	1998-12-30
K983267	Digora for Windows 2.0	Orion Corporation Soredex	MUH	Class II	1998-12-30
K983055	Rx Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003	Boston Scientific Corporation	LIT	Class II	1998-12-30
K982791	Rocs Tps	Radiation Oncology Computer Systems	MUJ	Class II	1998-12-30
K982549	Radionics Mini Multi-Leaf Collimator, Model Radionics Mmlc	Radionics, Inc.	IYE	Class II	1998-12-30
K982142	Mountable Endoscopic Knife	A.M. Surgical, Inc.	EMF	Class I	1998-12-30
K984164	Jelbond Np	Jelenko Co.	EJH	Class II	1998-12-29
K983990	Vitros Immunodiagnostic Products Cortisol Assay	Ortho-Clinical Diagnostics, Inc.	CGR	Class II	1998-12-29
K983535	The Titanium Miniplating System, the Titanium Microplating System, the Titanium Mediumplating System, Model #'S H12-1010	Hans Hermann GmbH	JEY	Class II	1998-12-29
K982337	Cuprophan and Hemophan Hollow Fiber Dialyzer	Haidylena Medical Egypt	FJI	Class II	1998-12-29
K974332	Variable Pressure Syringe Pump	CareFusion 303, Inc	FRN	Class II	1998-12-29
K984535	Puritan-Bennett 840 Ventilatory System with Bilevel Option	Medtronic, Inc.	CBK	Class II	1998-12-28
K983952	Greiner Vacuette Blood Collection Tube	Greiner Meditech, Inc.	JKA	Class II	1998-12-28
K983921	Autostat II Ena Screen Elisa	Cogent Diagnotics, Ltd.	LLL	Class II	1998-12-28
K983484	Dupel B.l.u.e. Small Iontophoresis Electrode	Empi	EGJ	Class II	1998-12-28
K982562	Bio-Eye Hydroxyapatite Ocular Impland and Conformer	Integrated Orbital Implants Inc	HPZ	Class II	1998-12-28
K980878	Pulmotrack,model 1010	Karmel Medical Acoustic Technologies, Ltd.	BZM	Class II	1998-12-28
K983811	Unipolar Optical Biopsy Forceps	Olympus Winter & Ibe GmbH	KGE	Class II	1998-12-24
K983559	Blood Tubing Accessory with Clave Connector	Abbott Medical	FJK	Class II	1998-12-24
K984500	Cordis Brite Tip Catheter Sheath Introducer System	Cordis US Corp.	DYB	Class II	1998-12-23
K984384	6.8/7.3 Buffer Pack-Model A473-496, Wash Solution Pack-Model A73-497	Thermo Bioanalysis Corp.	CHL	Class II	1998-12-23
K984359	Aia-Pack Troponin I Assay	Tosoh Medics, Inc.	MMI	Class II	1998-12-23
K984211	Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303	Medscand AB	HIB	Class II	1998-12-23
K984145	Olympus Myoglobin Immunoturbidmetric Reagent	Olympus Diagnostica GmbH	DDR	Class II	1998-12-23
K984020	Powdered Latex Examination Glove with Protein Content Labeling Claim (150 Micrograms or Less)	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	1998-12-23
K984019	Powder-Free, Latex Patient Examination Glove with Protein Content Labelling Claim (50 Micrograms or Less)	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	1998-12-23