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 2026-10-26, 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 670 of 3530

510(k) clearances, page 670 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152512	Half Dome Posterior Lumbar Interbody System	Astura Medical	MAX	Class II	2016-01-28
K152344	Total Bilirubin	Randox Laboratories, Limited	JFM	Class II	2016-01-28
K152188	QUAD Dental Implants and Prostheses	Dentack Impants, Ltd.	DZE	Class II	2016-01-28
K151716	Cable-Ready Cable Grip System: Cable-Ready Bone Plate System	Zimmer GmbH	HRS	Class II	2016-01-28
K151436	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2016-01-28
K153729	8F FlowGate2 Balloon Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2016-01-27
K153500	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip	AtriCure, Inc.	FZP	Class II	2016-01-27
K153290	Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium	William A. Cook Australia Pty, Ltd.	MQL	Class II	2016-01-27
K152986	StatStrip Xpress 2 Glucose Hospital Meter System	Nova Biomedical Corporation	PZI	Class II	2016-01-27
K152233	BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux	Sportarredo Group S.C.	LEJ	Class II	2016-01-27
K151787	Holter System	Edan Instruments, Inc.	DQK	Class II	2016-01-27
K151367	Sydney IVF Hyaluronidase	William A. Cook Australia Pty, Ltd.	MQL	Class II	2016-01-27
K151354	Cervello STIM	Blackrock Neuromed	GYC	Class II	2016-01-27
K150672	VistaCam iX Proof	Durr Dental AG	NBL	Class II	2016-01-27
K153159	Vinyl patient examination glove, Powder Free	Xingyuan Plastic Products Co., Ltd.	LYZ	Class I	2016-01-26
K152456	CenterCross Ultra Catheter	Roxwood Medical, Inc.	DQY	Class II	2016-01-26
K151812	Patient Monitors Various Models	Philips North America LLC	MHX	Class II	2016-01-26
K151701	Tenodesis screw system	Normed Medizin-Technik GmbH	HWC	Class II	2016-01-26
K151405	Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology	Surgical Instrument Services and Savings(Dba Medline Renewal	NLQ	Unclassified	2016-01-26
K151259	Sysmex Automated Blood Coagulation Analyzer CS-2100i	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2016-01-26
K150498	Discovery 24	Brainmaster Technologies, Inc.	GWQ	Class II	2016-01-26
K143615	Antistatic Compact Space Chamber	Medical Developments International	NVP	Class II	2016-01-26
K153386	Perla Posterior Cervico-Thoracic Fixation system	Spineart SA	NKG	Class II	2016-01-25
K153166	Fusion Bx	Focal Healtcare, Inc.	LLZ	Class II	2016-01-25
K152977	Dg Pacs	DICOM Grid (dba Ambra Health)	LLZ	Class II	2016-01-25
K152520	Magicore System	Innobiosurg Co., Ltd.	DZE	Class II	2016-01-25
K152503	ImagenSPECT	Cardiovascular Imaging Technologies, LLC	KPS	Class II	2016-01-25
K152137	FacetBRIDGE System	Ldr Spine USA	MRW	Unclassified	2016-01-25
K151594	Ellipse Supplemental Instrument Trays	Ellipse Technologies, Incorporated	KCT	Class II	2016-01-25
K153679	Stryker Neptune E-SEP Smoke Evacuation Pencil	Stryker Corp.	GEI	Class II	2016-01-22
K153594	MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2016-01-22
K152887	Crosperio RX PTA Balloon Dilatation Catheter	KANEKA Corporation	LIT	Class II	2016-01-22
K152873	Crosstella RX Balloon Dilatation Catheter	KANEKA Corporation	LIT	Class II	2016-01-22
K152820	Ponto Bone Anchored Hearing System	Oticon Medical AB	MAH	Class II	2016-01-22
K152741	Mepiseal Soft Silicone Sealant	Molnlycke Health Care, US LLC	OMP	Class II	2016-01-22
K152676	Fd TENS 2090, Fd TENS 2095	FUJI Dynamics Limited	GZJ	Class II	2016-01-22
K152670	DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables	Medos International SARL	GWM	Class II	2016-01-22
K152497	PW Guidewires	Tatara Vascular, LLC	DQX	Class II	2016-01-22
K152447	ASAHI Caravel	Asahi Intecc Co., Ltd.	DQY	Class II	2016-01-22
K152400	General & Plastic Surgery Instruments	Sontec Instruments, Inc.	GCJ	Class II	2016-01-22
K152149	VersaOne Bladed Trocar 5mm	Medtronic, Inc.	GCJ	Class II	2016-01-22
K152100	Evogue Dental Unit	Takara Belmont Corporation	EIA	Class I	2016-01-22
K151996	Taurus C1	Shinhung Co. Ltd.	EIA	Class I	2016-01-22
K151617	Livewire Electrophysiology Catheter	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	NLH	Class II	2016-01-22
K151072	Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit	Solo-Dex	BSP	Class II	2016-01-22
K151048	CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set	Bracco Injeneering S.A.	IZQ	Class II	2016-01-22
K143042	SonarMed AirWave, Airway Monitoring System	Sonarmed, Inc.	OQU	Class II	2016-01-22
K142541	Pocket Neb	Microvaper Devices	CAF	Class II	2016-01-22
K153735	Release Laminoplasty Fixation System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	NQW	Class II	2016-01-21
K153695	Biomet Spine Fusion System	Highridge Medical, LLC	MAX	Class II	2016-01-21