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 1405 of 3531

510(k) clearances, page 1405 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040355	Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with Gbs Coating	Gish Biomedical, Inc.	DTR	Class II	2004-03-15
K040298	Acist Antiographic Injection System Contrast Management Disposable Kits	Acist Medical Systems, Inc.	DXT	Class II	2004-03-15
K040286	Ethox Surgi-Cuf Adult Disposable Blood Pressure Cuffs	Ethox Corp.	DXQ	Class II	2004-03-15
K040076	Anspach Advanced Micro Saw Attachments	The Anspach Effort, Inc.	HBE	Class II	2004-03-15
K034052	Black Colour Powder-Free Nitrile Rubber Examination Gloves	Latexx Manufacturing Sdn.Bhd.	LZA	Class I	2004-03-15
K033762	Serralapg	Serral, S.A. de C.V.	GAM	Class II	2004-03-15
K032743	Apex Nrg	Medicnrg, Ltd.	LQY	Unclassified	2004-03-15
K021569	Restful Nights, Ist-Appliance	Ottawa Dental Laboratory	LRK	Class II	2004-03-15
K040447	Trapezoid Rx Lithotripter Compatible Basket, Models 1086, 1087, 1088	Boston Scientific Corporation	LQC	Class II	2004-03-12
K040360	Emu128s, Model Ex-Nw-128S	Excel Tech., Ltd.	GWQ	Class II	2004-03-12
K040351	Randox Liquid Crp Controls	Randox Laboratories, Limited	JJX	Class I	2004-03-12
K040346	Modification to Oria Top Clip System	Ortho Tec, LLC	MNI	Class II	2004-03-12
K040320	Sinon Power Wheelchair, Sn-P401	Sinon Corporation	ITI	Class II	2004-03-12
K040295	Applied Laparoscopic Monopolar Scissors	Applied Medical Resources Corp	HET	Class II	2004-03-12
K040112	Trimed Bearing Plate; Trimed Volar Bearing Plate	Tri-Med, Inc.	HRS	Class II	2004-03-12
K040077	Immunicon Celltracks Autoprep System	Immunicon Corp.	GKH	Class I	2004-03-12
K040022	Stryker Leibinger Universal Distal Radius System	Stryker Leibinger	HRS	Class II	2004-03-12
K033944	Stelkast 32Mm Modular Ceramic Femoral Head	Globus Medical, Inc.	LZO	Class II	2004-03-12
K033919	Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs	Alcon Laboratories	LPL	Class II	2004-03-12
K033893	Spectrum Modular System	Depuy Orthopaedics Inc.	LPH	Class II	2004-03-12
K033870	Image Management System	Welch Allyn Inc	HEX	Class II	2004-03-12
K033503	Rfs Vacuum Gauge Scavenging Circuit	Accutron Inc	CBN	Class II	2004-03-12
K032936	Direct Ldl Cholesterol Liquid Color and Stanbio Direct Hdl/ldl Cholesterol Calibrator	Stanbio Laboratory	JIX	Class II	2004-03-12
K031794	Endoflex Tracheal Tube	Merlyn Associates, Inc.	BTR	Class II	2004-03-12
K031064	Invacare Polaris Ex CPAP, Model Isp3000	Invacare GmbH	BZD	Class II	2004-03-12
K040534	Vitalab Amylase Reagent	Clinical Data, Inc.	JFJ	Class II	2004-03-11
K040486	Medipacs	Neobit Co., Ltd.	LLZ	Class II	2004-03-11
K040453	Autopulse Resuscitation System, Model 100	Revivant Corp.	DRM	Class II	2004-03-11
K040370	Wbr-Fhr, Wbr-Fwb	Ultraspect, Ltd.	KPS	Class II	2004-03-11
K040353	Flight Sock	Ssl Americas, Inc.	DWL	Class II	2004-03-11
K040291	El-Ana Profiles: Anti-Chromatin	Theratest Laboratories, Inc.	LJM	Class II	2004-03-11
K040280	Precinorm Proteins in Urine/csf Precipath Proteins in Urine/csr Controls	Roche Diagnostics GmbH	JJY	Class I	2004-03-11
K040106	Bd Phoenix Automated Microbiology System -- Ampicillin -- Gram Positive	Becton Dickinson & Co	LON	Class II	2004-03-11
K040009	Freelite Human Kappa and Lambda Kits	The Binding Site	DFH	Class II	2004-03-11
K034028	Ath Femoral Stem	Wrightmedicaltechnologyinc	JDI	Class II	2004-03-11
K033913	Progreat	Terumo Medical Corp.	KRA	Class II	2004-03-11
K033894	Panasonic Wrist Blood Pressure Monitor, Models Ew 3031 and Ew 3032	Matsushita Electric Works, Ltd.	DXN	Class II	2004-03-11
K033876	Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 and 2422	Dolphin Medical, Inc.	DQA	Class II	2004-03-11
K033846	Kaen Yih Umbilical Cord Clamp	Kaen Yih Enterprise Co., Ltd.	HFW	Class II	2004-03-11
K033668	Navipro Knee Software Module	Kinamed Inc	HAW	Class II	2004-03-11
K033351	Global Resurfacing Unicompartmental (Gru) Knee	Global Orthopaedic Technology, USA, Inc.	HRY	Class II	2004-03-11
K033177	Powergrip Bipolar Coagulation Forceps, Model 824Xxxxx	Gunter Bissinger Medizintechnik GmbH	HET	Class II	2004-03-11
K040473	Oravive Tooth Revitalizing Paste	Novamin Technology, Inc.	LBH	Class II	2004-03-10
K040471	Olympus Ldl Cholesterol Reagent, Osr6196/osr6296; Olympus Ldl Cholesterol Calibrator, Odc0024	OLYMPUS Corporation of the Americas	JIT	Class II	2004-03-10
K040435	Roche Diagnostics Tina-Quant Iga Gen.2	Roche Diagnostics GmbH	CZP	Class II	2004-03-10
K040434	Roche Diagnostics Tina-Quant Igg Gen.2	Roche Diagnostics GmbH	DEW	Class II	2004-03-10
K040431	Roche Diagnostics Tina-Quant Igm Gen.2	Roche Diagnostics GmbH	DAO	Class II	2004-03-10
K040277	Liquichek Cardiac Marker Control Lt	Bio-Rad Laboratories Inc.	JJY	Class I	2004-03-10
K040086	Health Buddy with Buddylink	Health Hero Network, Inc.	DXN	Class II	2004-03-10
K034048	R&d Glu-Line Hematology Control	R & D Systems, Inc.	JJX	Class I	2004-03-10