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 1705 of 3531

510(k) clearances, page 1705 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993680	Synthetic Vinyl Medical Examination Powder Free Glove	Top Glove Sdn. Bhd.	LYZ	Class I	1999-12-13
K993572	Ceradium V Non-Precious Ceramic Alloy	Matech, Inc.	EJH	Class II	1999-12-13
K993308	Mentor Evacare Vaginal Pessaries	Mentor	HHW	Class II	1999-12-13
K983250	Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas Monitor	Magnetic Resonance Equipment Corp.	DSK	Class II	1999-12-12
K993914	Premier Toxins A&b, Model 616096	Meridian Diagnostics, Inc.	LLH	Class I	1999-12-10
K993833	Airlife Heated Ventilator and Breathing Circuits	Medtronic, Inc.	BZE	Class II	1999-12-10
K993822	Ebi Spinelink Anterior Cervical Spinal System	Ebi, LLC	KWQ	Class II	1999-12-10
K993799	Cg-7000Dx ECG Recorder/transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-12-10
K993464	Bardex I.c. Pediatric Foley Catheter	C.R. Bard Inc	MJC	Class II	1999-12-10
K993339	Endopearl with Threader	Linvatec Corporation	MAI	Class II	1999-12-10
K993226	Memcath Urology Catheter, Model 101 -000 - 006	Memcath Technologies, LLC	EZD	Class II	1999-12-10
K993103	Endoscopes,10mm Diameter 0 Degrees; Endoscopes, 10Mm Diameter, 30 Degrees; Endoscopes, 10Mm Diameter, 50 Degrees	Richard Wolf Medical Instruments Corp.	GCM	Class II	1999-12-10
K993074	Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525	Bionx Implants, Inc.	MAI	Class II	1999-12-10
K993072	Survivalink Multifunctional Electrode (Svl-9630)	Survivalink Corp.	MKJ	Class III	1999-12-10
K993062	Chest Drainage Tubing	Olson Medical Sales, Inc.	DWE	Class II	1999-12-10
K992943	Vit Enhancer	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1999-12-10
K992209	Custodiol	Dr. Franz Kohler Chemie GmbH	KDN	Class II	1999-12-10
K991878	Luma-Cath Steerable Ep Catheters	Irvine Biomedical. Inc.	DRF	Class II	1999-12-10
K991756	3 Channel Knee Electronic Amplified Stethoscope	Bio-Research Associates, Inc.	DQD	Class II	1999-12-10
K991714	Drg Conventional Electronic Digital Stethoscope, Model Echop 200-00	Doctor'S Research Group, Inc.	DQD	Class II	1999-12-10
K991465	Drug Stop	Texas Immunology, Inc.	MVO	Unclassified	1999-12-10
K990390	Heparin IV Flush Syringe, 10 U/ml \	Rocap Div. of Sabratek Corp.	FOZ	Class II	1999-12-10
K990308	Rocap Heparin IV Flush Syringe, 100U/ml	Rocap Div. of Sabratek Corp.	FOZ	Class II	1999-12-10
K983637	Actifresh 400 Lens	Hydron, Ltd.	LPL	Class II	1999-12-10
K993829	Accu-Chek Simplicity System	Roche Diagnostics GmbH	LFR	Class II	1999-12-09
K993821	Vectorsurge 4 Interferential Therapy Unit	Metron Medical Australia, Pty, Ltd.	IPF	Class II	1999-12-09
K993631	Qualitrol Tumor Marker Control, Levels 1 and 2	Seracare Technology	JJY	Class I	1999-12-09
K993475	Aurofluid M, Alloy No. 5315	Metalor Dental USA Corp.	EJS	Class II	1999-12-09
K993112	Xomed ENT RF System	Xomed, Inc.	GEI	Class II	1999-12-09
K993106	Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)	Smith & Nephew, Inc.	HRS	Class II	1999-12-09
K993095	Frialit-2 Select Components	Friadent GmbH	DZE	Class II	1999-12-09
K993063	Rusch Brillant Silicone Foley	Rusch Intl.	EZL	Class II	1999-12-09
K993054	Ultracision Harmonic Scalpel Coagulating Shears, Models Lcs-C5, Lcs-C1, Cs-23C, Cs-231, Cs-14C, Cs-141	Ethicon Endo-Surgery Inc	LFL	Unclassified	1999-12-09
K992995	Aromatic and Flavored Tongue Depressor	Aga Plastic Ind. Com. Ltda.	FMA	Class I	1999-12-09
K992939	Qualitrol Immunoassay Plus Control, Levels 1,2 and 3	Seracare Technology	JJY	Class I	1999-12-09
K992581	Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands	ArthroCare Corporation	GEI	Class II	1999-12-09
K992368	Lemaitre Embolectomy Catheter	Vascutech, Inc.	DXE	Class II	1999-12-09
K992298	Iriderm, Model Apex 800	Iridex Corporation	GEX	Class II	1999-12-09
K990503	Sulzer Vascutek Gelsoft Vascular Prosthesis	Sulzermedica	DSY	Class II	1999-12-09
K983907	Reliefband Nst Device Models Wb-2,Wb-6,Wb-R	Woodside Biomedical, Inc.	GZJ	Class II	1999-12-09
K983746	Microstrep Plus Panel	Dade Microscan, Inc.	JWY	Class II	1999-12-09
K993766	Helax-Tms V 5.0 Radiation Therapy Treatment Planning System	Helax AB	MUJ	Class II	1999-12-08
K993506	Pagalinor 4 , Alloy No. 5440	Metalor Dental USA Corp.	EJS	Class II	1999-12-08
K993505	V-Delta Special, Alloy No. 5154	Metalor Dental USA Corp.	EJS	Class II	1999-12-08
K992595	Hp Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement, Hp Viridia Cms 24/26, Rev K with	Hewlett-Packard Co.	MHX	Class II	1999-12-08
K991882	Nexflex Total Knee System	Nexmed, Inc.	JWH	Class II	1999-12-08
K993945	Bionike Aq Phencyclidine (Pcp) Test	Bionike Laboratories, Inc.	LCM	Unclassified	1999-12-07
K993774	Acist Angiographic Injection System, Model Cl1ooh	Acist Medical Systems, Inc.	DXT	Class II	1999-12-07
K993299	Sysmex Automated Coagulation Analyzer, Model Ca-1500	Siemens Healthcare Diagnostics Inc.	GKP	Class II	1999-12-07
K991706	Virtuoso-Stereotaxic Planning Software	Stryker Corp.	HAW	Class II	1999-12-07