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 2597 of 3530

510(k) clearances, page 2597 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895681	Contrast Background Material	Applied Medical Technologies	GAB	Class I	1989-10-24
K895616	L.t.c. Feeding Tube	Intl. Medical Marketing, Inc.	KNT	Class II	1989-10-24
K895565	Pemaco Economy Base Plate Wax-Medium Hard	Pemaco, Inc.	EGD	Class I	1989-10-24
K895392	Antimicrobial Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1989-10-24
K895346	Dr. Dry	Intellitech	KPN	Class II	1989-10-24
K895323	Model Dt-Bal, Balance Saver	Spectramed, LLC	KXO	Class II	1989-10-24
K895299	Lasermedic 1200 Ruby Laser System	Lasermetrics, Inc.	GEX	Class II	1989-10-24
K895222	Curay-Form	Scientific Pharmaceuticals, Inc.	EBI	Class II	1989-10-24
K895187	Fdl, Inc.'s Transport System	Fairleigh Dickinson Laboratories, Inc.	JTW	Class I	1989-10-24
K895182	Asi Cystoscope Sheath, Grasping Forceps & For.body	Advanced Surgical Intervention, Inc.	FAJ	Class II	1989-10-24
K895134	3M Instant Fit Custom Earmold	3M Company	ESD	Class I	1989-10-24
K894994	Dentin Bonding System	Cosmedent, Inc.	KLE	Class II	1989-10-24
K894951	Modified Hemoglobin Reagent Set	Macomb Biotechnology, Inc.	GKK	Class II	1989-10-24
K894839	Os-1 Occlusion System - 1	Medical, Inc.	BZC	Class II	1989-10-24
K894831	Portable Air Compressor Model Number 8125	Equi-Tron Mfg., Inc.	BTI	Class II	1989-10-24
K894622	Varicella Zoster Virus	Bion Ent., Ltd.	GQW	Class II	1989-10-24
K894486	Quantex Aso Plus (Latex,buffer Standard,control)	Biokit USA, Inc.	GTQ	Class I	1989-10-24
K894428	Hearing Aid (in-the-Ear)	Hearing Aid Express	ESD	Class I	1989-10-24
K894380	Dumon Tracheobronchial Stent	Bryan Corp.	NWA	Class II	1989-10-24
K894154	Metabolic Systems	Cybex	ISD	Class II	1989-10-24
K892710	Aristee (Temporary Crown & Bridge Resin)	Prometex, Inc.	EBG	Class II	1989-10-24
K891486	Ar-800Pa Respiration Module	Nihon Kohden America Inc	BZQ	Class II	1989-10-24
K890107	Gent-L-Kare(tm) Sterile, Pressure Sore Manage Kit	Premium Plastics, Inc.	FRO	Unclassified	1989-10-24
K890039	Kleen Test Basin Set	Kleen Test Products Corporation	JOL	Class II	1989-10-24
K883811	Electronic Pain Relievers	Jetco of America	GZJ	Class II	1989-10-24
K883418	De-Bond 200	Scheu-Dental GmbH	EKS	Class I	1989-10-24
K895665	Uric Acid Pap	Boehringer Mannheim Corp.	KNK	Class I	1989-10-23
K895596	Fortress 1000Fs Add-on Power Unit	Fortress Scientific, Ltd.	ITI	Class II	1989-10-23
K895135	Hi Chem Calibrator a+	Hichem Diagnostics	JIX	Class II	1989-10-23
K895108	Follicle Stimulating Hormone Mab Solid Phase Com.	BD Becton Dickinson Vacutainer Systems Preanalytic	CGJ	Class I	1989-10-23
K895086	Gauze Sponge	Keilei Intl., Inc.	EFQ	Unclassified	1989-10-23
K895022	Systemate Creatinine Test (Crea) #65413	Em Diagnostic Systems, Inc.	CGX	Class II	1989-10-23
K895006	Milenia(tm) Cortisol (Mkco1,5)	Siemens Healthcare Diagnostics Inc.	CGR	Class II	1989-10-23
K894680	Rs232 Flow Sensor and Software Package	Tamarac Systems Corp.	BZG	Class II	1989-10-23
K894627	Bt-338N Electronic Clinical Thermometer	Integrated Display Technology, Ltd.	FCI	Class II	1989-10-23
K894400	Micro-Plate Reader, Mdx-1	Medix Biotech, Inc.	JJX	Class I	1989-10-23
K893453	Glycaben	Exocell, Inc.	LCP	Class II	1989-10-23
K895591	Silicone Instrument Shods	Key Surgical, LLC	GDJ	Class I	1989-10-20
K895567	Primidone (Fpia) Kit	Tudor Laboratories, Inc.	LFT	Class II	1989-10-20
K895559	Modified Endoguide	Luxar Corp.	GEX	Class II	1989-10-20
K895409	Remington Tanfastic Countertop Facial Tanner	Remington Products Company LLC	LEJ	Class II	1989-10-20
K895348	Microruptor III System, Cw Argon Laser Component	Lasag Medical Lasers	GEX	Class II	1989-10-20
K895263	Illumina Model 25, 40 and 55 CO2 Laser Systems	Heraeus Lasersonics, Inc.	GEX	Class II	1989-10-20
K894721	Traumafuse Perfusion Pressure Relief Valve	The Traumafuse Co.	DWE	Class II	1989-10-20
K894719	Cypress Medical Bone Screw & Plates	Cypress Medical Mfg., Inc.	HWC	Class II	1989-10-20
K894668	Modified Shiley Therapeutic Autotransfusion System	Shiley, Inc.	CAC	Class II	1989-10-20
K894658	Kinemax Total Knee System Femoral Spacers	Howmedica Corp.	JWH	Class II	1989-10-20
K894644	Crown and Bridge Dental Restorative Composite Syst	Jeneric/Pentron, Inc.	EBF	Class II	1989-10-20
K894639	Skyrock and Light Superbond	Dent Zar, Inc.	DYH	Class II	1989-10-20
K894630	Shiley Plexus(tm) Adult Hollow Fiber Oxygenator	Shiley, Inc.	DTZ	Class II	1989-10-20