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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 500 of 3529

510(k) clearances, page 500 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182072	VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides	Ortho-Clinical Diagnostics, Inc.	CGZ	Class II	2018-10-30
K182066	O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set	Cook Incorporated	KOB	Class II	2018-10-30
K182063	VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System	Ortho-Clinical Diagnostics, Inc.	JFY	Class II	2018-10-30
K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	Sysmex America, Inc.	JOY	Class II	2018-10-30
K181550	Cios Spin	Siemens Medical Solutions USA, Inc.	OWB	Class II	2018-10-30
K181488	LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier	Ethicon Endo-Surgery Inc	FZP	Class II	2018-10-30
K180718	Orthodontic Plastic Brackets and Accessories	Tomy, Inc.	DYW	Class II	2018-10-30
K180354	UroGen Ureteral Catheter	Urogen Pharma Ltd.	KOD	Class II	2018-10-30
K182914	MC3 Vascular Access Kit 21030	Mc3 Incorporated	DRE	Class II	2018-10-29
K182215	ClearLink Controlled Phototherapy Equipment	The Daavlin Distributing Co.	FTC	Class II	2018-10-29
K181239	Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer	Joytech Healthcare Co., Ltd.	FLL	Class II	2018-10-29
K180559	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	ELITechGroup Inc	PGI	Class II	2018-10-29
K180020	HemoScreen Hematology Analyzer	Pixcell Medical Technologies, Ltd.	GKZ	Class II	2018-10-29
K181458	Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter	Innovative Health, LLC.	NLH	Class II	2018-10-27
K180980	ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System	Camber Spine Technologies	NKB	Class II	2018-10-27
K182767	V2 OTC Pain Relief TENS	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2018-10-26
K182753	A6 OTC Pain Relief TENS	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2018-10-26
K182501	Hair Laser Headband	Pulsaderm, LLC	OAP	Class II	2018-10-26
K182299	MAGNETOM Aera	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-10-26
K182177	Accipiolx	Maxq AL, Ltd.	QAS	Class II	2018-10-26
K182041	Dexcom G6 Glucose Program Continuous Glucose Monitoring System	Dexcom, Inc.	QDK	Class II	2018-10-26
K181898	Two-Step Implant System	Trilliant Surgical LLC	HWC	Class II	2018-10-26
K181739	Invisalign System with Mandibular Advancement Feature	Align Technology, Inc.	NXC	Class II	2018-10-26
K181031	TSI Transseptal Introducer	Pressure Products Medical Device Manufacturing LLC	DYB	Class II	2018-10-26
K180487	Peak.me	Breathe Me, Ltd.	BZH	Class II	2018-10-26
K180300	Margolin HSG Cannula, Goldstein Sonohysterography Catheter	Cook Incorporated	LKF	Class II	2018-10-26
K180291	Cook Silicone Balloon HSG Catheter	Cook Incorporated	LKF	Class II	2018-10-26
K180286	Polyethylene Catheter	Cook Incorporated	DQO	Class II	2018-10-26
K180285	PENTAX Medical Video Colonoscope EC34-i10T Series	Pentax Medical of America, Inc.	FDF	Class II	2018-10-26
K173965	Implant Planning Software	Inteware Co., Ltd	LLZ	Class II	2018-10-26
K170732	Biomate Dental Implant System	Biomate Medical Devices Technology Co., Ltd.	DZE	Class II	2018-10-26
K182706	External upper limb tremor stimulator	Cala Health, Inc.	QBC	Class II	2018-10-25
K182464	PeekMed	Peek Health, S.A.	LLZ	Class II	2018-10-25
K182171	SMV Scientific K-Wire and Pins	Summit Medventures	JDW	Class II	2018-10-25
K181947	Persona Revision Knee System	Zimmer GmbH	JWH	Class II	2018-10-25
K181936	DyeVert PLUS EZ Contrast Reduction System	Osprey Medical, Inc.	DXT	Class II	2018-10-25
K181902	Codman Certas Plus Electronic Tool Kit	Integra LifeSciences Corporation	JXG	Class II	2018-10-25
K181685	Vivid E80, Vivid E90, Vivid E95	GE Healthcare	IYN	Class II	2018-10-25
K181468	Hybrid3D	Hermes Medical Solutions AB	KPS	Class II	2018-10-25
K181354	074 Zenith Flex System	Inneuroco, Inc.	NRY	Class II	2018-10-25
K181186	Solitare Platinum Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	POL	Class II	2018-10-25
K181116	Convivo	Carl Zeiss Meditec Inc	GWG	Class II	2018-10-25
K180688	SLENDERTONE CoreFit Abs 8, Type 734	Bio-Medical Research, Ltd.	NGX	Class II	2018-10-25
K180258	SpeediCath Standard	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2018-10-25
K173944	Endocular Viewing Lenses and Silicone Ring	Phakos	HJK	Class II	2018-10-25
K170723	Swaive Thermometer SWT1A	E-Care Technology Corporation	FLL	Class II	2018-10-25
K182647	Gc70	Samsung Electronics Co., Ltd.	KPR	Class II	2018-10-24
K182365	TempSure System	Cynosure, LLC	GEI	Class II	2018-10-24
K182322	Duo Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2018-10-24
K182318	Retina Workplace	Carl Zeiss Meditec Inc	NFJ	Class II	2018-10-24