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 809 of 3530

510(k) clearances, page 809 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132995	Dlp Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Line, Dlp Retrograde Coronary Sinus Perfusio	Medtronic, Inc.	DWF	Class II	2013-10-31
K132924	Medtronic External Pulse Generator (Epg)	Medtronic, Inc.	DTE	Class II	2013-10-31
K132705	Unique	Varian Medical Systems, Inc.	IYE	Class II	2013-10-31
K132586	Paxerapacs	Paxeramed	LLZ	Class II	2013-10-31
K132280	Altus Spine Pedicle Screw System	Altus Partners	MNI	Class II	2013-10-31
K132209	Ips E.max Cad Abutment Solutions	Ivoclar Vivadent, Inc.	NHA	Class II	2013-10-31
K132014	Gsb Global Spinal Balance System	NuVasive Inc	NKB	Class II	2013-10-31
K131914	Offroad Re-Entry Catheter System	Boston Scientific Corporation	PDU	Class II	2013-10-31
K131894	Nidek Green Laser Photocoagultor Model Gyc-1000 Connected with the Endophotocoagulation Delivery Unit	Nidek Co., Ltd.	GEX	Class II	2013-10-31
K131748	Osseofuse Dental Implant System	Osseofuse, Inc.	DZE	Class II	2013-10-31
K131222	Ampcare Esp Therapy System	Ampcare, LLC	IPF	Class II	2013-10-31
K130827	Firmap Catheter	Topera, Inc.	MTD	Class II	2013-10-31
K123155	Luna Dental Implant System	Shinhung MST Co., Ltd.	DZE	Class II	2013-10-31
K122040	Invotec Laryngeal Electrode	Invotec International, Inc.	ETN	Class II	2013-10-31
K133122	Immulite 2000; 3Gallergy Specific Ige Control Verification Material (Cvm), Total Ige Control Verification Material (Cvm)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-10-30
K132796	Suntouch Eye Spear	HuiZhou Foryou Medical Devices Co., Ltd.	HOZ	Class II	2013-10-30
K132357	Smith & Nephew Ultratape	Smith & Nephew, Inc.	GAT	Class II	2013-10-30
K132316	Multiview	Hologic, Inc.	LLZ	Class II	2013-10-30
K132305	Stentboost Rel. 4	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-10-30
K132248	Flower Bone Screw Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HWC	Class II	2013-10-30
K132166	Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with Softline Coating, Vacuum-Tight	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2013-10-30
K132025	Meso Bilayer Surgical Mesh	Kensey Nash Corporation dba Dsm Biomedical	FTM	Class II	2013-10-30
K131893	Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical Lights	Ajw Technology Consultants, Inc.	FSY	Class II	2013-10-30
K131719	Ophthalmoscopes Diagnostic Instrument Kits	Medical Devices (Pvt) Ltd.	HLJ	Class II	2013-10-30
K131116	U2 Total Knee System - Psa Type, Offset Stem Adapter	United Orthopedic Corp.	JWH	Class II	2013-10-30
K130784	Spirotel	Mir Medical Intl. Research SRL	BZG	Class II	2013-10-30
K130675	Arthrex Univers II Ca Heads	Arthrex GmbH	HSD	Class II	2013-10-30
K130534	Diplomat	Diplomat Dental s.r.o.	EIA	Class I	2013-10-30
K122783	Plasmafit Acetabular Cup and Vitelene Insert	Aesculap Implant System, Inc.	OQG	Class II	2013-10-30
K132325	Guidor Bioresorbable Matrix Barrier	Sunstar Americas, Inc.	NPK	Class II	2013-10-29
K131867	2.5Mm Inline Fusion Plate	Zimmer GmbH	HRS	Class II	2013-10-29
K131190	Mypatch	dms-service LLC	DSH	Class II	2013-10-29
K130274	Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System	Elite Surgical Supplies (Pty) Ltd	MAX	Class II	2013-10-29
K130178	Inspiration Ventilator System 5I/7i	Event Medical Ltd	CBK	Class II	2013-10-29
K130117	Network Eye Spears, Points, Drains, Wicks and Shields	Network Medical Products, Ltd.	HOZ	Class II	2013-10-29
K130048	Reverse Shoulder Prosthesis Monoblock	Encore Medical, LP	KWS	Class II	2013-10-29
K123910	Woundwash Saline Spray	Neilmed Pharmaceuticals Inc	FRO	Unclassified	2013-10-29
K132972	Affinity Fusion Cardiotomy/venous Reservoir with Balance Biosurface	Medtronic, Inc.	DTN	Class II	2013-10-28
K132866	Nautilus Spinal System	Life Spine	NKB	Class II	2013-10-28
K132651	Itclamp 50	Innovative Trauma Care Inc	DXC	Class II	2013-10-28
K132462	S Test Reagent Cartridge Bun and S Test Reagent Cartridge Cre	Canon Medical Diagnostics USA, Inc.	CDN	Class II	2013-10-28
K132126	Spectrum Spine Fenestrated Facet Screw System	Spectrum Spine Inc	MRW	Unclassified	2013-10-28
K132083	Azur Pure Peripheral Coil Systems, Pushable 35	Terumo Cardiovascular Systems Corporation	KRD	Class II	2013-10-28
K131446	Integra Jarit Heparin Cannulas, Injectors, and Needles	Integra LifeSciences Corporation	DQR	Class II	2013-10-28
K131336	Tx Wheelchair Chassis	Jcm Seating Solutions, Ltd.	IOR	Class I	2013-10-28
K123958	Jiajian Pointoselect Digital	Wuxi Jiajian Medical Instrument Co., Ltd	GZJ	Class II	2013-10-28
K133124	Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total Tbg Calibra	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-10-25
K132900	Marauder Cervical-Thoracic Spinal Fixation System	Intelligent Implant Systems, LLC	KWP	Class II	2013-10-25
K132809	Instinct Endoscopic Hemoclip	Wilson-Cook Medical Inc.	PKL	Class II	2013-10-25
K132227	Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium Control-Level I, Liquichek Immunoassay	Bio-Rad Laboratories Inc.	JJY	Class I	2013-10-25