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 2026-10-29, 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 780 of 3530

510(k) clearances, page 780 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133522	Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),rightest New Adapters-3,Ge Diabetes Managem	Bionime Coporation	NBW	Class II	2014-04-17
K133421	Straumann Magellan(tm) Abutment,protective Cap,titanium Copings,gold Chopings,basal Screw	Straumann USA, LLC	NHA	Class II	2014-04-17
K133270	Speed Arc	Biomedical Enterprises, Inc.	JDR	Class II	2014-04-17
K133006	Neov Diode Laser Family	G.N.S Neolaser Ltd.	GEX	Class II	2014-04-17
K132976	Advatx	AdvaLight ApS	GEX	Class II	2014-04-17
K132789	Flip Introducer Access Kit	Vascular Solutions LLC	DYB	Class II	2014-04-17
K132724	Iconn Answer Suture Anchor	Iconn Orthopedics, LLC	MBI	Class II	2014-04-17
K132547	Endo Tool Glucose Management System (Egms)	Monarch Medical Technologies	NDC	Class II	2014-04-17
K131962	Da Vinci Sp Surgical System, Endowrist Sp Instruments, and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2014-04-17
K131852	Hc-1 and Hc-1 Classic	Transcendencias Comerciales SL Transcom	KPL	Class II	2014-04-17
K131660	Smart (Smart-D, Smart-Dx)	Bts S.p.A.	LXJ	Class II	2014-04-17
K131189	Unicel Dxc Synchron Systems Glucose Reagent (Gluh)	Siemens Healthcare Diagnostics Inc.	CFR	Class II	2014-04-17
K140673	Insertion Tool	Boston Scientific Corporation	DQX	Class II	2014-04-16
K140664	Human Alpha2-Macroglobulin Kit for Use on Spaplus	The Binding Site Group Ltd.	DEB	Class II	2014-04-16
K140639	Prosound F75 Diagnostic Ultrasound System	Hitachi Aloka Medical, Ltd.	IYN	Class II	2014-04-16
K140475	Rotating Adapters	Merit Medical Systems, Inc.	DTL	Class II	2014-04-16
K140396	Freelite Human Lambda Free Kit	The Binding Site Group Ltd.	DEH	Class II	2014-04-16
K140288	Truepath Cto Device	Boston Scientific Corporation	PDU	Class II	2014-04-16
K140092	Currie Medical Reprocessed Alp Calf/thigh/foot Compression Sleeve (All Sizes)	Currie Medical Specialties, Inc.	JOW	Class II	2014-04-16
K133815	Intess Cervical Cage System	Kalitec Direct, LLC	ODP	Class II	2014-04-16
K133791	Ora 0.4Mm [S], Ora 1.0Mm [S], Ora 2.0Mm [S], Ora 3.0Mm [S], Ora 4.0Mm [S]	Sterngold Dental LLC	NHA	Class II	2014-04-16
K133783	Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization	AmeriWater LLC.	FIP	Class II	2014-04-16
K133707	Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements	CooperSurgical, Inc.	MQL	Class II	2014-04-16
K133524	Pvmed Ddr 2430T	Portavision Medical, LLC	MQB	Class II	2014-04-16
K132620	Inter V Kyphoplasty Catheter (Balloon Length: 0 Mm), Interv Kyphoplasty Catheter (Balloon Lenght: 15 Mm), Interv Kyphopl	Pan Medical, Ltd.	NDN	Class II	2014-04-16
DEN140005	Lyra Direct Strep Assay	Ortho-Clinical Diagnostics, Inc.	PGX	Class II	2014-04-16
K140831	Maxzero Extension Set with Needless Connector	Care Fusion	FPA	Class II	2014-04-15
K140503	Flexiva Sf Side-Firing Single-Use Laser Fiber	Boston Scientific Corporation	GEX	Class II	2014-04-15
K133905	6200 / 6250 Ultrasound System	Esaote S.p.A.	IYN	Class II	2014-04-15
K133389	Em40 Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	NBW	Class II	2014-04-15
K132738	Cogent Med-Lif	Cogent Spine, LLC	MAX	Class II	2014-04-15
K140219	Picasso II Mis Spinal System	Accel Spine	NKB	Class II	2014-04-14
K140194	Namic Rcs Syringe	Boston Scientific Corporation	FMF	Class II	2014-04-14
K140191	Elisio-H Hemodialyzer	Nipro Medical Corporation	KDI	Class II	2014-04-14
K134010	Cabochon System	Cabochon Aesthetics, Inc.	OUP	Class II	2014-04-14
K133957	Disposable Adjustable PEEP Valve Mr Conditional Use	Galemed Corp.	BYE	Class II	2014-04-14
K132999	Cervical Stand Alone System	Orthofix SRL	OVE	Class II	2014-04-14
K132940	Erchonia Allay	Erchonia Medical, Inc.	NHN	Class II	2014-04-14
K132930	Myhealthpoint Telehealth Manager	Entra Health Systems	DRG	Class II	2014-04-14
K130852	Avance® Foam Abdominal Dressing Kit	Molnlycke Health Care	OXJ	Class II	2014-04-14
K130778	Discoscopes, Cervical Endoscopes	RZ Medizintechnik GmbH	HRX	Class II	2014-04-14
K140646	Digital Flat Panel X-Ray Detector / 1717G, Xmaru1717g	Rayence Co., Ltd.	MQB	Class II	2014-04-11
K140645	Gibralt Rod-to-Rod Cross Connectors	Exactech Sarasota	KWP	Class II	2014-04-11
K134047	Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical Forceps	Integra LifeSciences Corporation	HCZ	Class II	2014-04-11
K134039	Daytona Icg (P200ticg)	Optos PLC.	MYC	Class II	2014-04-11
K134015	M-Pm-Disc	Merz Dental GmbH	MQC	Unclassified	2014-04-11
K133932	Inion Freedompin	Inion Oy	HTY	Class II	2014-04-11
K133923	Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet	Reflectance Medical, Inc.	MUD	Class II	2014-04-11
K133781	Declipsespect Laparoscopy	Surgiceye GmbH	IZD	Class I	2014-04-11
K133705	Revolution CT	GE Healthcare	JAK	Class II	2014-04-11