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 2549 of 3530

510(k) clearances, page 2549 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K901305	Model 2121-21, Tmj Surface Coil	Medical Advances, Inc.	LNH	Class II	1990-04-26
K901276	Hemacon-Doa(tm) Drugs of Abuse Whole Blood Control	Siemens Healthcare Diagnostics Inc.	DIT	Class II	1990-04-26
K901242	Model 2121-64; Tmj Surface Coil	Medical Advances, Inc.	LNH	Class II	1990-04-26
K901227	Surgilase CO2 Surgical Laser Systems Model Sl120	Surgilase, Inc.	GEX	Class II	1990-04-26
K901211	Surgilase Sl50 Surgical Laser System	Surgilase, Inc.	GEX	Class II	1990-04-26
K900943	Modified Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	DEW	Class II	1990-04-26
K900921	Hycor Accupinch Phencyclidine Test	Hycor Biomedical	LCM	Unclassified	1990-04-26
K900826	'Apnea-Electrode'	Medical Science Products, Inc.	BZQ	Class II	1990-04-26
K900755	Digital Cuff Pv Gauge	International Medical Products, Inc.	BSK	Class II	1990-04-26
K900743	Cmv-Igm Ifa Test System	Zeus Scientific LLC	LKQ	Class II	1990-04-26
K900717	Technicon Testpoint(tm) Ligand Control	Technicon Instruments Corp.	JJY	Class I	1990-04-26
K900686	Maxi Compressors	Medical Industries America, Inc.	BTI	Class II	1990-04-26
K900622	Modified Model 5401B Test Cable	Medtronic, Inc.	DXY	Class III	1990-04-26
K900598	Tramscope System	Marquette Electronics, Inc.	DPS	Class II	1990-04-26
K897029	Model Ecg100 Simulator	Dynatech/Nevada, Inc.	DPS	Class II	1990-04-26
K896620	Neurotens	Henley Intl.	GZJ	Class II	1990-04-26
K896555	Cts Computed Tomography (CT) Attachment	W. L. Systems, Inc.	KPQ	Class II	1990-04-26
K895538	Angioscope W/the Optiscope-2 Integrated Angioscopy	Trimedyne, Inc.	LYK	Class II	1990-04-26
K895402	Endocoagulator 2001 Kli	Cabot Medical Corp.	HGI	Class II	1990-04-26
K891927	Telemetry Power Pack Model 2	Lucas & Rhea Mfg.	FCP	Class I	1990-04-26
K901702	Nad Reduction, Alt/spgt Codes 7722,7723,7422,7522	American Research Products Co.	CKA	Class I	1990-04-25
K901693	Technicon Chem 1 Clinical Analyzer for Urine Uric	Technicon Instruments Corp.	KNK	Class I	1990-04-25
K901323	Hydra View Imaging System	Mallinckrodt Group, Inc.	JAA	Class II	1990-04-25
K901298	Creatinine Reagent for Au5000 Clin Lab Anal-Modify	Olympus Corp.	CGX	Class II	1990-04-25
K901266	Coulter Total Bilirubin Reagent	Coulter Corp.	CIG	Class II	1990-04-25
K901257	Wirontom Clasp Wire	Ivoclar North America, Inc.	EJW	Class I	1990-04-25
K901241	Thoracic/lumbar Spine 8 Racetrack Coil, 3080-64	Medical Advances, Inc.	LNH	Class II	1990-04-25
K901116	Sterile Latex Patient Examination Gloves	Medi Tex, Inc.	LYY	Class I	1990-04-25
K901099	Protocol (Alloy)	Ivoclar North America, Inc.	EJS	Class II	1990-04-25
K901097	Fillock Reamer	Ivoclar North America, Inc.	DZA	Class I	1990-04-25
K901024	Stainless Steel Dental Wires and Clasps	Ivoclar North America, Inc.	EJF	Class I	1990-04-25
K900940	Tdx Phencyclidine II Assay	Abbott Medical	LCM	Unclassified	1990-04-25
K900819	Blood Gas Calibration Standard	Cryogenic Rare Gas Laboratories, Inc.	LCH	Class I	1990-04-25
K900803	Dual Lumen Sub-Clavian Catheters Dlsc 600S & 800S	Akcess Medical Products, Inc.	LFJ	Class II	1990-04-25
K900781	Working Channel Valve	Applied Urology, Inc.	FFY	Class I	1990-04-25
K900643	Fluid Soakershield	Infection Control Products, Inc.	KME	Class I	1990-04-25
K900618	Huntleigh Fetal Doppler, Fd-1 & Dopcord, D140	Huntleigh Technology, Inc.	KNG	Class II	1990-04-25
K900363	Neophor-Mc	L.S. Scientific	EGJ	Class II	1990-04-25
K896881	Latex Dental & Examination Gloves	American Intl. Health Industries P.R., Inc.	LYY	Class I	1990-04-25
K896598	Strato Indwelling Catheter	Strato Medical Corp.	LJS	Class II	1990-04-25
K896407	Haemotronic Blood Line Set	Healthcare Suppliers, Inc.	FJK	Class II	1990-04-25
K896357	Safe Aid Device Impotence Device	Dr. John P. March	LKY	Class II	1990-04-25
K894935	S-70 Portable Dental X-Ray System	Lorad Medical Systems, Inc.	EHD	Class II	1990-04-25
K894883	Phycon All Silicone Balloon Catheter	Vitaid, Ltd.	EZL	Class II	1990-04-25
K894184	Biedermann Motech Universal Spinal System	Biedermann Motech GmbH	JDN	Class II	1990-04-25
K881681	Cybex Back Testing and Rehabilitation System	Cybex	IKK	Class II	1990-04-25
K881676	Linear Lift Device	Cybex	IKK	Class II	1990-04-25
K901677	Carapace Portable Cast Saw, Swiss-Ex Cast Cutter	Buckman Co., Inc.	LGH	Class I	1990-04-23
K901525	K-Cape Orthopedic Wires and Pins	Westcon Orthopedics, Inc.	KTT	Class II	1990-04-23
K901272	Orion Blade Plate for Tibial Osteotomy	Med-Tek Corp.	KTT	Class II	1990-04-23