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 2391 of 3531

510(k) clearances, page 2391 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915705	Acid Phosphatase Reagent Set	Tech Intl. Co.	CKE	Class II	1992-02-27
K915644	Cedars-Sinai Quantitative Thallium-201 Analysis	Nuccardiac Software, Inc.	KPS	Class II	1992-02-27
K915552	Instrumentarium Mega4	Instrumentarium Imaging, Inc.	LNH	Class II	1992-02-27
K915535	Forearm Software for Lunar Dpx Series Bone Desitom	Lunar Corp.	KGI	Class II	1992-02-27
K915496	Deseret Guidewire Introducer	BD Becton Dickinson Vacutainer Systems Preanalytic	DQX	Class II	1992-02-27
K915450	In the Ear Hearing Aid	Zenith/Omni Hearing Instruments, Inc.	ESD	Class I	1992-02-27
K915421	Guidewire Introducer Set	B. Braun of America, Inc.	DYB	Class II	1992-02-27
K915253	Ir-192 Implant, Modification	Omnitron Intl., Inc.	IWA	Class II	1992-02-27
K915189	Steriletx Powder Free Latex Examination Gloves	Transcorp	LYY	Class I	1992-02-27
K914954	Spectacle Frames+ Sunglassses(non Presc.)	Jsu Corp.	HQZ	Class I	1992-02-27
K914807	Apex Helix - a	Elscint, Inc.	KPS	Class II	1992-02-27
K914747	Xenon Circuit	Gibeck, Inc.	IYT	Class II	1992-02-27
K914531	Stainless Steel Gen Pur Interventional Guide Wires	Arrow Intl., Inc.	DQX	Class II	1992-02-27
K914444	Xpr Printer Redundancy	Vortech Data, Inc.	LMD	Class I	1992-02-27
K914417	Mediquip I.a. Field Conv Kit/amsco 2080 Ser Table	Med Vac LLC	IXR	Class II	1992-02-27
K914404	Ortho Software Used W/lunar Dpx/dpx-L/dps-@ Desit	Lunar Corp.	KGI	Class II	1992-02-27
K914366	Medrad Pathfinder Hr Roadmapping System	Medrad, Inc.	LLZ	Class II	1992-02-27
K914305	Sytec Dentascan	General Electric Co.	JAK	Class II	1992-02-27
K914259	Touch Talker	Prentke Romich Co.	ILQ	Class II	1992-02-27
K913941	Psg(tm) 20 Guage Doppler Needle	Peripheral Systems Group	ITX	Class II	1992-02-27
K913693	Enzygnost(r) Anti-Cmv/igm	Behring Diagnostics, Inc.	LFZ	Class II	1992-02-27
K912728	Altair	Diagnostic Medical Instruments	DQK	Class II	1992-02-27
K912618	Laser Systems for Percutaneous Lumbar Discectomy	Heraeus Lasersonics, Inc.	GEX	Class II	1992-02-27
K915707	Ammonia Reagent Set	Tech Intl. Co.	JIF	Class I	1992-02-26
K915305	Option U1 for the Dps-Plus System	Philips North America LLC	LLZ	Class II	1992-02-26
K914283	Thayer Expansion Chamber Metered Dose Inhaler	Thayer Medical Corportation	CAF	Class II	1992-02-26
K914219	Airway Thermistor	Synectics-Dantec	BZG	Class II	1992-02-26
K914109	Pikos 01 & Pikos E 01	BIOTRONIK AG	DXY	Class III	1992-02-26
K914105	Cathwriter(tm)	Softheart, Inc.	DQK	Class II	1992-02-26
K913790	Sensormedics Oxyshuttle Ii(tm)	Sensor Medics Corp.	DQA	Class II	1992-02-26
K912685	Mem-4204-4-8, Meb-4204 &4208 Evoke Potent Meas Sys	Nihon Kohden America Inc	GWF	Class II	1992-02-26
K915626	Ez Gold	Ivoclar North America, Inc.	EJT	Class II	1992-02-25
K915619	Ionofil/lonofil Molar	Voco GmbH	EMA	Class II	1992-02-25
K915618	Provicol	Voco GmbH	EMA	Class II	1992-02-25
K915439	Nasogastric Feeding Tube Kits	Sandoz Nutrition	FPD	Class II	1992-02-25
K914849	Excel Model Xlt-One Nd:yag Laser System	Excel Tech., Ltd.	GEX	Class II	1992-02-25
K914492	Gastrointestinal Tube and Accessories	Sandoz Nutrition	FPD	Class II	1992-02-25
K913974	Access Impression Barrel	Centrix, Inc.	EID	Class I	1992-02-25
K913407	Nasojejunal Feeding Tube W/gastric Drainage	Sandoz Nutrition	FPD	Class II	1992-02-25
K905809	Nmc Cycler Machine	National Medical Care, Medical Products Div., Inc.	FKX	Class II	1992-02-25
K915809	Visitec Canalicular Stent	Visitec Co.	LZU	Unclassified	1992-02-24
K915484	Urethralpressure Profile Catheter	Life-Tech Intl., Inc.	FAP	Class II	1992-02-24
K915457	Phaco 20/20 System I	Innovative Medical Systems, Inc.	HQC	Class II	1992-02-24
K915438	Feeding Tube Y-Port Connector	Sandoz Nutrition	FPD	Class II	1992-02-24
K915354	Lateralase	Trimedyne, Inc.	GEX	Class II	1992-02-24
K914580	Drs-4 Dialyzer Reprocessing System	Seratronics, Inc.	LIF	Class II	1992-02-24
K914244	Sterile Custom Surgical Kits	Ulti-Med Intl., Inc.	KDD	Class I	1992-02-24
K914215	Selectacut Biopsy Device	Biomni Medical Systems, Inc.	KNW	Class II	1992-02-24
K914174	Sterile Disposable Wet Skin Scrub Tray	Medical Device Inspection Company	LRO	Class II	1992-02-24
K912888	Uritec Test Strip & Human Urine + & - Test Control	Dynagen, Inc.	MIG	Unclassified	1992-02-24