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 2026-11-02, 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 2398 of 3531

510(k) clearances, page 2398 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915000	Acu-Guard	Acuderm, Inc.	GEX	Class II	1992-01-27
K914976	Opti-Plast 5F Pta Catheters, Modification	Vas-Cath, Inc.	LIT	Class II	1992-01-27
K914861	Evacuation Kit #7-510-14	Northgate Technologies Inc.	GCJ	Class II	1992-01-27
K914815	Il Test(tm) Benzodiazepine	Instrumentation Laboratory Co.	JXM	Class II	1992-01-27
K914809	Mp Mini Photometer	Artel, Inc.	JJX	Class I	1992-01-27
K914570	Disposable Vascular Angioscope	Nobles-Lai	LYK	Class II	1992-01-27
K914311	Chiroflex II Lens Microsert(tm)	Chiron Ophthalmics	HQL	Class III	1992-01-27
K914185	Pacel(tm) Flow Directed Pacing Catheter	Daig Corp.	LDF	Class II	1992-01-27
K914169	Whiteside Ortholoc Mod.tibial Augmentation Comp	Dow Corning Wright	JWH	Class II	1992-01-27
K914159	Glucose Reagent Set	Tech Intl. Co.	CGA	Class II	1992-01-27
K914022	Seriological Test Kit/igm Antibody Vari-Zost Virus	Pharmacia Diagnostics, Inc.	LFY	Class II	1992-01-27
K913799	Lm-90 Esu	Keisegang Medical, Inc.	GEI	Class II	1992-01-27
K913773	Cobe Brat Systems without Reinfusion Protection	LivaNova USA, Inc.	CAC	Class II	1992-01-27
K913708	Venus Hip	Turnkey Intergration USA, Inc.	LWJ	Class II	1992-01-27
K913341	Bard(r) Coude Tip Temperature Sensing Catheter	C.R. Bard Inc	EZC	Class II	1992-01-27
K913094	Disposable Slide Valve Manifold	Professional Medical Services	DQO	Class II	1992-01-27
K920134	Philips 41 Series Rainbow	Philips Int'L B.V.	ESD	Class I	1992-01-24
K920112	Clinitron C-II	Support Systems Intl.	INX	Class II	1992-01-24
K915853	Tangent V	Fischer Imaging Corp.	IXR	Class II	1992-01-24
K915614	Bte Hearing Aid Multifocus	Opticon Corp.	ESD	Class I	1992-01-24
K915542	Qca Plus	Sanders Data Systems, LLC	LLZ	Class II	1992-01-24
K915537	Earbear Otoscope	Earbear Co.	ERA	Class I	1992-01-24
K915472	Electrocardiograph Transmitter	Tz, Inc.	DXH	Class II	1992-01-24
K914907	Quicvage	Autovage	KDH	Class II	1992-01-24
K914855	Multiple Dose Controller	Block Medical, Inc.	FRN	Class II	1992-01-24
K914854	Thumper	Block Medical, Inc.	FRN	Class II	1992-01-24
K914414	Video Fluoroscope	Raymax Medical Corp.	JAA	Class II	1992-01-24
K914251	Model Irc Passport Nebulizer	Invacare GmbH	LAW	Class I	1992-01-24
K913886	Sony Dvr-10 Digital Videocassette Recorder	Sony Medical Electronics Co.	JAA	Class II	1992-01-24
K913210	M. Kurosaka(tm) Fixation Screw	Depuy, Inc.	HWC	Class II	1992-01-24
K912882	Innervision Laparoscope and Accessories	M.D. Engineering, Inc.	HET	Class II	1992-01-24
K920142	Philips M60 Series	Philips Int'L B.V.	ESD	Class I	1992-01-23
K915616	Urihesive Strip	Convatec, A Division of E.R. Squibb & Sons	EXI	Class I	1992-01-23
K915463	Activated Partial Thromboplastin Time	Sigma Diagnostics, Inc.	GGW	Class II	1992-01-23
K915395	Magnetic Resonane Diagnostic Device Accessory	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-01-23
K915298	Suction/irrigation Cannula; Catlog #532.00	Lifeguard Medical Products, Inc.	GCJ	Class II	1992-01-23
K915274	Metal Halide Light Source Model Lm 250	Pentax Precision Instrument Corp.	FST	Class II	1992-01-23
K915223	Metal Enclosed Side Firing Fibers	Trimedyne, Inc.	GEX	Class II	1992-01-23
K915199	Storz Imaging System	Fischer Imaging Corp.	IZI	Class II	1992-01-23
K914896	Friedmann Analyser 3	Clement Clarke, Inc.	HOK	Class I	1992-01-23
K914852	Elisa Toxo Igm	Sclavo, Inc.	LGD	Class II	1992-01-23
K914808	Leksell Gammaplan (Lgp)	Elekta Instruments, Inc.	IWB	Class II	1992-01-23
K914587	Grieshaber Air/fluid Tubing Set	Grieshaber & Co.	KYG	Class I	1992-01-23
K914557	Econoaid	Gromedco	LKY	Class II	1992-01-23
K913769	Syrex Syringe	Special Machinery Co.	EJI	Class II	1992-01-23
K913673	Vectra Magnetic Resonance System	General Electric Co.	LNH	Class II	1992-01-23
K913485	CT Sytec 8000	General Electric Co.	JAK	Class II	1992-01-23
K913374	Cardio Perfect, Cardio Perfect Md	Cardio Control BV	DPS	Class II	1992-01-23
K913314	Candela Retinal Camera	Candela Corporation	HKI	Class II	1992-01-23
K913169	Dantec Ud 5500 Mk2	Dantec Medical, Inc.	FAP	Class II	1992-01-23