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 701 of 3530

510(k) clearances, page 701 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K150587	Cortex Laser System	Cynosure, Inc. dba Ellman	GEX	Class II	2015-07-21
K150537	MiNi Internal Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2015-07-21
K150365	Cloud9 System	Insleep Technologies, LLC	BZD	Class II	2015-07-21
K150350	Flexi-Seal Signal Fecal Management System	ConvaTec Limited	KNT	Class II	2015-07-21
K143650	CooperSurgical Advincula Delineator Uterine Manipulator	CooperSurgical, Inc.	HEW	Class II	2015-07-21
K143356	NovoStitch Plus Meniscal Repair System	Ceterix Orthopaedics, Inc.	GAT	Class II	2015-07-21
K143268	TENS and Powered Muscle Stimulator	Shenzhen As-Tec Technology Co., Ltd.	NUH	Class II	2015-07-21
K143033	Dentca Denture Base	Dentca, Inc.	EBI	Class II	2015-07-21
K151696	Caiman Seal and Cut Technology	Aesculap Inc	GEI	Class II	2015-07-20
K150886	Trojan Riviera Personal Lubricant	Church & Dwight Co., Inc.	NUC	Class II	2015-07-20
K150756	Micro well group culture dish, 9-well; Micro well group culture dish, 16-well	Hertart	MQK	Class II	2015-07-20
K150088	Evacore Fully Disposable Vacuum Assist Biopsy Device	Pin-Point Care Corp.	KNW	Class II	2015-07-20
K150066	Exactech Alteon Monobloc Revision Stem	Exactech, Inc.	LZO	Class II	2015-07-20
K143322	Medline Natural Lubricating Liquid	MEDLINE INDUSTRIES, LP - Northfield	NUC	Class II	2015-07-20
K142827	Visi Mobile Monitoring System, Visi Mobile Chest Sensor	Sotera Wireless	MHX	Class II	2015-07-20
K141777	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	DZE	Class II	2015-07-20
K151707	EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i	Rayence Co., Ltd.	MUH	Class II	2015-07-19
K151709	Hi-Light Diagnostic Ultrasound Systems	Qingdao Hisense Medical Equipment Co.,Ltd.	IYO	Class II	2015-07-17
K151685	Gua60a, Gu60a-65	Samsung Electronics Co., Ltd.	KPR	Class II	2015-07-17
K151681	IntelliVue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	DSI	Class II	2015-07-17
K151659	ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks	Medtronic, Inc.	GDW	Class II	2015-07-17
K151654	Prow Fusion	Nlt Spine, Ltd.	MAX	Class II	2015-07-17
K151505	Coronis Uniti	Barco N.V.	PGY	Class II	2015-07-17
K151486	Biograph mCT and mCT Flow PET/CT Scanners	Siemens Medical Solutions USA, Inc.	KPS	Class II	2015-07-17
K151198	A-CIFT SoloFuse	SPINEFRONTIER, Inc. dba LESspine Innovations	OVE	Class II	2015-07-17
K151101	Lotus Series 4 Ultrasonic Surgical System & Accessories	SRA Developments Ltd	LFL	Unclassified	2015-07-17
K151046	illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10	Meridian Bioscience Inc	PGI	Class II	2015-07-17
K150909	INTEGO Family and Accesories	Sirona Dental Systems GmbH	EIA	Class I	2015-07-17
K150866	SURGISEAL Topical Skin Adhesvie	Adhezion Biomedical, LLC	MPN	Class II	2015-07-17
K150839	3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90	Varian Medical Systems, Inc.	JAQ	Class II	2015-07-17
K150776	Medrobotics Flex System	Medrobotics Corporation	EOB	Class II	2015-07-17
K150380	ProMIS Fixation System	Premia Spine Ltd.	NKB	Class II	2015-07-17
K150272	Capnostream 35 Portable Respiratory Monitor	Oridion Medical 1987 Ltd.	CCK	Class II	2015-07-17
K150245	CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX	GE Healthcare Finland Oy	CCK	Class II	2015-07-17
K143687	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2015-07-17
K143176	UltraLinq	Ultralinq Healthcare Solutions, Inc.	LLZ	Class II	2015-07-17
K142651	The Moses Express appliance	Allen J. Moses, Dds, Ltd.	LRK	Class II	2015-07-17
K151690	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	Alere Scarborough, Inc.	OOI	Class II	2015-07-16
K151660	MultiFIX S Knotless Fixation System	ArthroCare Corporation	MBI	Class II	2015-07-16
K151557	EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine	Nantong Egens Biotech Co., Ltd.	DNK	Class II	2015-07-16
K151523	Uncoated Tubing and Connector Components	Medtronic, Inc.	DWF	Class II	2015-07-16
K151377	ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare	Medical Compression System (Dbn), Ltd.	JOW	Class II	2015-07-16
K151326	RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device	Smith & Nephew, Inc.	OMP	Class II	2015-07-16
K150953	Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC	Bio Compression Systems, Inc.	JOW	Class II	2015-07-16
K150850	Refobacin Bone Cement R	Zimmer GmbH	MBB	Class II	2015-07-16
K150128	GC Ortho Connect, GC Ortho Etching Gel	GC Orthodontics America Inc.	DYH	Class II	2015-07-16
K143103	PROPENCIL Smoke Pencil	Bio Protech, Inc.	GEI	Class II	2015-07-16
K143011	2014 InterActive/SwishActive System	Implant Direct Sybron Manufacturing LLC	DZE	Class II	2015-07-16
K142965	Virtuoso System for IHC PR (1E2) using iScan HT	Ventana Medical Systems Inc	OEO	Class II	2015-07-16
K151677	LnK Cervical Interbody Fusion Cage System	L&K Biomed Co.,Ltd.	ODP	Class II	2015-07-15