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 1306 of 3531

510(k) clearances, page 1306 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051857	Veo Multigas Monitor for Pocket Pc, Model 400221	Weissburg Associates	CCK	Class II	2005-09-15
K051718	Nuvasive Neurovision Jjb System	NuVasive Inc	ETN	Class II	2005-09-15
K051461	3I Osseotite Dental Implants	ZimVie US Corp LLC	DZE	Class II	2005-09-15
K051313	Bi-Naps Nasal Airflow and Snore Transducer	Salter Labs	MNR	Class II	2005-09-15
K051260	Schuco Mist and Schuco Deluxe Mist	Allied Medical LLC	CAF	Class II	2005-09-15
K052454	The Emboshield Embolic Protection System	Abbott Vascular	NTE	Class II	2005-09-14
K052355	Automated Breast Ultrasound System, Model Abus	U-Systems, Inc.	IYO	Class II	2005-09-14
K052345	Advantage Sim Md	GE Healthcare	KPQ	Class II	2005-09-14
K052344	Color Lcd Monitor, Model Radioforce R31 & R31-C	Eizo Nanao Corporation	LLZ	Class II	2005-09-14
K052325	Cyberknife System for Stereotactic Radiosurgery/radiotherapy	Accuray Incorporated	MUJ	Class II	2005-09-14
K052324	Polaris Lv, Lva Applicator	Syneron Medical, Ltd.	GEX	Class II	2005-09-14
K052248	Dorsal Nail Plate, Anatomical	Hand Innovations, Inc.	HRS	Class II	2005-09-14
K052247	Nex-Link Spinal Fixation System Variable Crosslink, Model 721-Xx	Spinal Concepts, Inc.	KWP	Class II	2005-09-14
K052211	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	GXQ	Class II	2005-09-14
K052084	Endo-Ease Endoscopic Overtube	Spirus Medical, LLC	FED	Class II	2005-09-14
K051922	Asa 'M Family' Diode Laser, Model Mi, Mix5, M6	Cynosure, LLC	ILY	Class II	2005-09-14
K051852	Single Amplifier for Botox	Allergan	GWL	Class II	2005-09-14
K051366	Piconibp Oem Module	Philips Medizin Systeme Boeblingen GmbH	DXN	Class II	2005-09-14
K050729	Alcon Multi-Purpose Disinfecting Solution	Alcon Laboratories	LPN	Class II	2005-09-14
K050524	Ez-IV Medical Pad Warming Unit, Model 1000	Marda Medical, Inc.	IRQ	Class I	2005-09-14
K050382	Affinity Qs Q-Switched Nd:yag Laser System	Cynosure, LLC	GEX	Class II	2005-09-14
K050085	Osteopal V	Kulzer GmbH	LOD	Class II	2005-09-14
K052219	Crono Go.	Cane S.r.l.	FRN	Class II	2005-09-13
K052217	Crono Super Pid	Cane S.r.l.	FRN	Class II	2005-09-13
K052214	Pre-Powdered Sterile Exam Gloves	Kanam Latex Industries Pvt. Ltd.	LYY	Class I	2005-09-13
K052152	B-Bop Plate	New Deal, S.A.	HRS	Class II	2005-09-13
K052048	Accordion	Percutaneous Systems, Incorporated	FFL	Class II	2005-09-13
K052030	Surgeon's Glove, Powder Free	Shun Thai Rubber Gloves Industry Public Co., Ltd.	KGO	Class I	2005-09-13
K051899	Bd Pen Needle	Becton Dickinson & Co	FMI	Class II	2005-09-13
K051749	Cobra Surgical System	Estech, Inc.	GEI	Class II	2005-09-13
K050760	Accu-Chek Pocket Compass Diabetes Management Software	Roche Diagnostics GmbH	LZG	Class II	2005-09-13
K052302	Hemashield Platinum Woven Double Velour Taaa Graft Configuration	Boston Scientific Corporation	MAL	Class II	2005-09-12
K052224	Bd Probe Tec Urine Preservative Transport	Becton Dickinson & Co	LSL	Class II	2005-09-12
K052205	Capiox Af125x Arterial Filter	Terumo Cardiovascular Systems Corporation	DTM	Class II	2005-09-12
K052031	Powdered Latex Surgeon's Glove	Shun Thai Rubber Gloves Industry Public Co., Ltd.	KGO	Class I	2005-09-12
K052015	Dimension Extended Range Cyclosporine Calibrator, Catalog # Dc108	Siemens Healthcare Diagnostics Inc.	DLJ	Class II	2005-09-12
K051825	Cognitrace	Eemagine Medical Imaging Solutions GmbH	GWQ	Class II	2005-09-12
K051655	Angiodynamics, Inc., Micro Access Kits	Boston Scientific Corporation	DQR	Class II	2005-09-12
K051565	Proton Digital Blood Pressure Monitor, Models Ph168a, Ph168e, Ph168w, Phc888ja, Ph888ha	Proton Healthcare, Ltd.	DXN	Class II	2005-09-12
K052389	I-Port	Patton Medical Devices	FOZ	Class II	2005-09-09
K052375	Alilife Stand Up Powered Wheelchair, Hc-300	Alilife Technological Co., Ltd.	IPL	Class II	2005-09-09
K052362	Bis EEG Monitor, Model a-3000	Aspect Medical Systems, Inc.	OLW	Class II	2005-09-09
K052353	Z-Chair	Pride Mobility Products Corp	ITI	Class II	2005-09-09
K052330	Tru-Swab Stocock	Medegen Medical Manufacturing Services	FMG	Class II	2005-09-09
K052117	I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)	Halyard Health	MEB	Class II	2005-09-09
K051904	All Purpose Cuff, Model 222Apc	Suntech Medical, Inc.	DXQ	Class II	2005-09-09
K051876	Multiwave Xr	Pacific Quantum Instruments, Inc.	GEX	Class II	2005-09-09
K051810	Whole Pth (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3Kg014	Scantibodies Laboratory Inc.	CEW	Class II	2005-09-09
K051665	Synthes Vectra-T System	Synthes GmbH	KWQ	Class II	2005-09-09
K051614	Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics	Lifecore Biomedical LLC	DZE	Class II	2005-09-09