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 934 of 3530

510(k) clearances, page 934 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K103251	Duocentric Reversed	Aston Medical	PHX	Class II	2011-10-28
K103155	Sumo Access and Tissue Resection System	Apollo Endosurgery, Inc.	ODC	Class II	2011-10-28
K112917	Attain Lds 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery System, Attain 6216A and 6218A Guid	Medtronic, Inc.	DQY	Class II	2011-10-27
K112911	Fetal Doppler	Beijing Choice Electronic Technololgy Co., Ltd.	KNG	Class II	2011-10-27
K112849	Fixate Tissue Band	Anulex Technologies, Inc.	GZB	Class II	2011-10-27
K112844	Rehastim 2, Rehamove 2	Hasomed GmbH	GZI	Class II	2011-10-27
K112713	Norfolk Medical-Sportport-Family of Ports	Norfolk Medical Products, Inc.	LJT	Class II	2011-10-27
K112670	Dx-D 600	AGFA Healthcare Corp.	KPR	Class II	2011-10-27
K112631	Vsi Guidewire	Vascular Solutions LLC	DQX	Class II	2011-10-27
K112604	21.3 Inch (54 Cm) Color Lcd Monitor Ccl356i2 (Cl21356)	Totoku Electric Co., Ltd.	LLZ	Class II	2011-10-27
K112529	Td-5000 & Td-6000 Ultrasonic Tabletop Doppler	Advanced Instrumentations, Inc.	KNG	Class II	2011-10-27
K112466	4Mp Color Lcd Monitor, Radiforcerx430	Eizo Nanao Corporation	LLZ	Class II	2011-10-27
K112222	Alcatron and / or Multiple Brand	Alcatron Gloves Factory	LYZ	Class I	2011-10-27
K112178	Jms Apheresis Needle Set Wingeater(r) V2	JMS North America Corp.	FIE	Class II	2011-10-27
K111796	Invizia Anterior Cervical Plate System	Zimmer Spine, Inc.	KWQ	Class II	2011-10-27
K111723	Turbohawk Peripheral Plaque Excision System	Medtronic, Inc.	MCW	Class II	2011-10-27
K111434	Giotto Image 3D, Giotto Image 3D-L	Giotto USA, LLC	MUE	Class II	2011-10-27
K111296	Zoll Rescuenetlink	ZOLL Medical Corporation	MSX	Class II	2011-10-27
K111010	Spiderfx Embolic Protection Device	Medtronic, Inc.	NTE	Class II	2011-10-27
K110655	Mahe Perfect Spine- Pedicle Screw System	Mahe Medical GmbH	NKB	Class II	2011-10-27
K110326	Osram Itos	Osram Sylvania, Inc.	ERA	Class I	2011-10-27
K110206	Aesculap- Meithke Shunt System	Aesculap Inc	JXG	Class II	2011-10-27
K112810	Multi-Analyte Detection Systems	Bio-Rad Laboratories Inc.	NHX	Class II	2011-10-26
K112689	Synthes Sternal Fixation System	Synthes GmbH	HRS	Class II	2011-10-26
K112520	US-101L, US-103S	Ito Co., Ltd.	IMI	Class II	2011-10-26
K112174	Ncb Periprosthetic Femur Polyaxial Locking Plate System	Zimmer GmbH	HRS	Class II	2011-10-26
K112000	Vitek 2 Streptococcus Penicillin	bioMerieux, Inc.	LON	Class II	2011-10-26
K111828	Clearsplint Es	Astron Dental Corporation	MQC	Unclassified	2011-10-26
K111822	Sta(r) - Liquid Anti-Xa, Multi Hep Calibrator, Quality Hnf / Ufh, Quality Hbpm / Lmwh	Diagnostica Stago, Inc.	KFF	Class II	2011-10-26
K111621	Masimo Resposable Spo2 Series Oximetry Sensors, Masimo Lncs / M-Lncs Oximetry Sensors	Masimo Corporation	DQA	Class II	2011-10-26
K111520	Ipc Powerease System	Medtronic Xomed, Inc.	HBE	Class II	2011-10-26
K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis	MAX	Class II	2011-10-26
K110551	Expedium Spine System	Johnson & Johnson	NKB	Class II	2011-10-26
K112842	Ams Elevate Pc	American Medical Systems, Inc.	OTP	Class III	2011-10-25
K112828	Revive Intermediate Catheter (Revive Ic)	Cerenovus, Inc.	DQY	Class II	2011-10-25
K112786	Proseries Bioimplants-Proankle/procuff	Synovis Orthopedic & Woundcare	FTM	Class II	2011-10-25
K112701	Charger Balloon Dilatation Catheter	Boston Scientific Corporation	FGE	Class II	2011-10-25
K112249	Healix Knotless(tm) Anchor	DePuy Mitek, Inc.	MAI	Class II	2011-10-25
K112192	Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens	Bausch & Lomb Incorporated	MVN	Class II	2011-10-25
K111965	Vusion(r) Os	Ortho Development Corp.	MAX	Class II	2011-10-25
K111825	Endo Gia(tm) Staplers, Dst Series(tm) Gia(tm) Staplers, Dst Series(tm) Ta(tm) Staplers	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2011-10-25
K111538	Skaffold Cis	Skeletal Kinetics, LLC	MTJ	Unclassified	2011-10-25
K110998	Affirm (Tm) Vcf System	Algea Therapies	NDN	Class II	2011-10-25
K102454	I-Neb Aad System with Tim; I-Neb Insight Aad System	Respironics Respiratory Drug Delivery (Uk), Ltd.	CAF	Class II	2011-10-25
K112803	Patient Monitor	Guangdong Biolight Meditech Co., Ltd	MHX	Class II	2011-10-24
K112497	Meridian Filter System - Femoral Delivery Kit	C.R. Bard Inc	DTK	Class II	2011-10-24
K112177	Sofia Analyzer and Influenza A+b Fia	Ortho-Clinical Diagnostics, Inc.	PSZ	Class II	2011-10-24
K111993	Framewalker	Quantum Medical Concepts, LLC	KTT	Class II	2011-10-24
K111948	Wingeater V2	JMS North America Corp.	FIE	Class II	2011-10-24
K110783	Venus Interbody Fixation System- Venus Plif/tlif, Alif Peek Cage	L&K Biomed Co.,Ltd.	MAX	Class II	2011-10-24