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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1716 of 3533

510(k) clearances, page 1716 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K993490	Quickstrip One Step Opiates Test	Syntron Bioresearch, Inc.	DJG	Class II	1999-10-29
K993287	Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labeling Claim	Pan-Century Rubber Products Sdn. Bhd.	LYY	Class I	1999-10-29
K993093	Health-Plus, Sanitex, Reliance (50 Micrograms)	Pamitex Industries Sdn Bhd	LYY	Class I	1999-10-29
K993091	Palmaz Xl Tanshepatic Biliary Stents	Cordis US Corp.	FGE	Class II	1999-10-29
K992953	Surgeons Glove, Brown Latex Polymer Coated, Powder Free with Protein Label Claim	Ansell Perry	KGO	Class I	1999-10-29
K992841	Tg Medical Powdered Nitrile Blue Examination Gloves	TG Medical Sdn Bhd	LZA	Class I	1999-10-29
K992649	Atd Automatic Bridge Remover	J. Morita USA, Inc.	EIS	Class I	1999-10-29
K992618	Respalert	Harwill Medical (Pty), Ltd.	BZH	Class II	1999-10-29
K992586	Konica Laser Imager, Drypro Model 722	Konica Corp.	LMC	Class II	1999-10-29
K992583	Mass (Micro-Access Spine System)	Omni-Tract Surgical, Div. Minn. Scientific, Inc.	HRX	Class II	1999-10-29
K992574	Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models 1210-Vhp, 1500A	Trimedyne, Inc.	GEX	Class II	1999-10-29
K992560	Maps 10000	Web Link Medical	KPS	Class II	1999-10-29
K991918	Nutrisafe Extension Tube	Vygon Corp.	KNT	Class II	1999-10-29
K990738	Dr. Jahanger's Cutter	M.S. Jahanger, MD	KNA	Class II	1999-10-29
K993354	K-Assay Apo B	Kamiya Biomedical Company, LLC	DER	Class II	1999-10-28
K993266	Prowler Plus Infusion Catheter	Cordis Neurovascular, Inc.	KRA	Class II	1999-10-28
K993245	Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom	Alba Critical Care, Ltd.	DYG	Class II	1999-10-28
K992169	Acs Hi-Torque Cross-It 400Xt Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1999-10-28
K991879	Spring-Wound Epidural Catheter	Micor, Inc.	BSO	Class II	1999-10-28
K991601	Dual Lumen Catheter, Model Dl-35-90	Endologix LLC	DQY	Class II	1999-10-28
K990410	Seraquest Eb Vca Igg	Quest Intl., Inc.	LSE	Class I	1999-10-28
K993433	Virtuoso Lx Smart CPAP System	Respironics, Inc.	BZD	Class II	1999-10-27
K993373	Rotorblade Suture Anchor	Li Medical Technologies, Inc.	MAI	Class II	1999-10-27
K993307	Aria Lx CPAP System	Respironics, Inc.	BZD	Class II	1999-10-27
K993269	Iq Nasal Mask, Model P/n 50160	SleepNet Corporation	BZD	Class II	1999-10-27
K993258	Supergloves, Powder Free Nitrile Examination Gloves	Supermax Sdn Bhd	LZA	Class I	1999-10-27
K993240	Sensi-Pro Disposable Powder Free Vinyl Synthetic Examination Gloves with White Pigment Additives	Shinemound Enterprise, Inc.	LYZ	Class I	1999-10-27
K993231	Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves with White Pigment Additives	Shinemound Enterprise, Inc.	LYZ	Class I	1999-10-27
K993192	Illusion	Bisco Inc	EBF	Class II	1999-10-27
K993097	Health-Plus, Sanitex, Reliance Pre-Powdered Latex Examinatino Gloves, with Protein Content Labeling Claim (100 Microgram	Pamitex Industries Sdn Bhd	LYY	Class I	1999-10-27
K993045	Bariatric Laparoscope, Model 367	Stryker Corp.	GCJ	Class II	1999-10-27
K992830	Safeskin Polymer-Coated Nitrile Examination Gloves, Powder-Free Shieldmaster Nitrile Glove	Safeskin Corp.	LZA	Class I	1999-10-27
K992784	Next Generation Rodding System	United States Surgical, A Division of Tyco Healthc	KWQ	Class II	1999-10-27
K992667	Zmr Hip System-Revision Taper	Zimmer GmbH	LPH	Class II	1999-10-27
K992653	Shelly Protected Av Fistula Needle	Diasol, Inc	FIE	Class II	1999-10-27
K992643	Model Irc 1001 Aerosol Compressor	Invacare GmbH	CAF	Class II	1999-10-27
K992617	Hex Button	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HTN	Class II	1999-10-27
K992616	Sdb Cerclage System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1999-10-27
K992601	Temp Teller - Digital Thermometer, Models Dt-101, Dt-102, Dt-103, Dt-201, Dt-202, Dt-203	Oriental System Technology, Inc.	FLL	Class II	1999-10-27
K992551	Alpha Infusion Pump	Advanced Infusion, Inc.	MEB	Class II	1999-10-27
K992542	Tubular Electrode Device	Conway Stuart Medical, Inc.	GEI	Class II	1999-10-27
K992421	Guardian Low Pressure Alarm Accessory, Model 34076	Accutron Inc	BSZ	Class II	1999-10-27
K992266	IV Administration Set	New Alliance of Independent Medical Distributors	FPA	Class II	1999-10-27
K992156	Synsation Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves	Ansell Perry	LYZ	Class I	1999-10-27
K992070	Cook Ultra Quiet Vacuum Pump & Regulator	Cook Incorporated	MQG	Class II	1999-10-27
K991281	Electric Mobility Cavalier Scooters	Electric Mobility	INI	Class II	1999-10-27
K990233	St-302 Infrarex	Skylark Device Co., Ltd.	ILY	Class II	1999-10-27
K984465	Oxyconalpha with Option ECG	Erich Jaeger, Inc.	LOS		1999-10-27
K983613	Pre-Powdered Non-Sterile Vinyl Examination Gloves	Shanghai Jiatai Plastic Products Co., Ltd.	LYZ	Class I	1999-10-27
K983000	Cricothyrotomy Tube	Polamedco, Inc.	BTO	Class II	1999-10-27