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 671 of 3530

510(k) clearances, page 671 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K153421	Hi Vision Ascendus, Hv Ascendus, Ascendus	Hitachi Aloka Medical America, Inc.	IYN	Class II	2016-01-21
K153402	Discovery NM/CT 670 CZT	GE Healthcare	KPS	Class II	2016-01-21
K153381	Corin Metafix Hip Stem	Corin USA	LZO	Class II	2016-01-21
K153034	aap LOQTEQ VA Radius Set 2.5	AAP Implantate AG	HRS	Class II	2016-01-21
K152926	AQUACEL Ag Surgical SP Dressing	ConvaTec Limited	FRO	Unclassified	2016-01-21
K152833	Pruitt F3-S Polyurethane Carotid Shunt	LeMaitre Vascular Inc.	MJN	Class II	2016-01-21
K152810	DeVilbiss DV6WM Wireless Modem	Sunrise Medical, Inc.	BZD	Class II	2016-01-21
K152802	Grasping Forceps	Micro-Tech (Nanjing) Co., Ltd.	OCZ	Class II	2016-01-21
K152672	Cajun Commando 4x4	Lil Critter, LLC	ITI	Class II	2016-01-21
K151570	Carestation 620/650/650C	GE Healthcare	BSZ	Class II	2016-01-21
K151303	AirLife Infant Heated Wire Circuit	Care Fusion	BZE	Class II	2016-01-21
K150888	Shape-HF Cardiopulmonary Testing System	Shape Medical Systems, Inc	BTY	Class II	2016-01-21
K153681	PleuraFlow System	Clearflow, Inc	OTK	Class II	2016-01-20
K153672	basixTOUCH40 Inflation Syringe	Merit Medical Systems, Inc.	MAV	Class II	2016-01-20
K153643	Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives	Alcon Laboratories	LPL	Class II	2016-01-20
K153642	DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal	Alcon Laboratories	LPL	Class II	2016-01-20
K153626	SonoSite Edge II Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2016-01-20
K152790	Venus Versa System	Venus Concept Inc.	ONF	Class II	2016-01-20
K152584	Stroke VCAR	GE Medical Systems SCS	JAK	Class II	2016-01-20
K152473	CAS-One IR	Cascination	JAK	Class II	2016-01-20
K152463	SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant	Poriferous, LLC	FWP	Class II	2016-01-20
K152352	Stereo 3D option for Vision Applications	GE Medical Systems SCS	LLZ	Class II	2016-01-20
K152311	Pentacam AXL	Oculus Optikgerate GmbH	MXK	Class II	2016-01-20
K152241	Medtronic Transportation/Sterilization Cassettes	Medtronic Sofamor Danek USA Inc	KCT	Class II	2016-01-20
K151959	AirLife Infant Single Limb Heated Wire Circuit	CareFusion 303, Inc	BZE	Class II	2016-01-20
K151726	AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer	Stryker Corp.	MAX	Class II	2016-01-20
K151620	Firefly Peritoneal Dialysis Connector Disinfection System	Puracath Medical, Inc.	KDJ	Class II	2016-01-20
K151558	Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System	Neurotherapies Reset GmbH	KLW	Class II	2016-01-20
K153669	MultiFIX S Ultra Knotless Fixation System	Arthocare Corporation	MBI	Class II	2016-01-19
K153664	M.U.S.T. Pedicle Screw System	Medacta International SA	NKB	Class II	2016-01-19
K153618	Capillus202	Capillus, LLC	OAP	Class II	2016-01-19
K153373	CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device	Medtronic Sofamor Danek	ODP	Class II	2016-01-19
K153333	Epic Extremity Cannulated Screw System	Epic Extremity, LLC	HWC	Class II	2016-01-19
K152980	Flo Trac sensor, Volume View sensor	Edwards Lifesciences LLC	DRS	Class II	2016-01-19
K152793	Unison-C Anterior Cervical Fixation System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	OVE	Class II	2016-01-19
K152613	True Flow Valvuloplasty Perfusion Catheter	C.R. Bard Inc	OZT	Class II	2016-01-19
K152215	Dentalos Plus Mono, Dentalos Plus Multicolor	Dentalplus GmbH	EBG	Class II	2016-01-19
K151969	Hospira Extension Sets	Abbott Medical	FPA	Class II	2016-01-19
K151029	Phadia Prime	Phadia AB	DHB	Class II	2016-01-19
K143713	Lustre PRO Light System	Ambicare Health, Ltd.	GEX	Class II	2016-01-19
K153675	Paragon T2 Wand with Integrated Cable	ArthroCare Corporation	GEI	Class II	2016-01-15
K153598	Medtronic Bio-Medicus Adult Cannula Kit	Medtronic, Inc.	DWF	Class II	2016-01-15
K153289	Healthmyne	Healthmyne, Inc.	LLZ	Class II	2016-01-15
K152777	Bovie Disposable Bipolar Ablator	Apyx Medical Corporation	GEI	Class II	2016-01-15
K152697	Infx-8000C, V6.20	Toshibamedical Systems Corporation	OWB	Class II	2016-01-15
K152690	Disposable Thermometer Probe Sheaths	Pinghu Sama Medical Packing Co., Ltd.	FLL	Class II	2016-01-15
K152669	PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)	Pms Tip Teknolojileri Sanayi ve Ticaret Limited Std	FRG	Class II	2016-01-15
K152620	Spine Wave Gen II Expandable Interbody System	Spine Wave Inc	MAX	Class II	2016-01-15
K152531	InstaClear Lens Cleaner	Gyrus ACMI, Inc.	EOB	Class II	2016-01-15
K152522	ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes	Microtek Medical LLC	LHC	Class I	2016-01-15