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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1545 of 3531

510(k) clearances, page 1545 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012520	Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model Gtl-20E	Cardiac Assist Devices, Inc.	DRF	Class II	2002-03-27
K011400	Mrsa-Screen	Denka Seiken'S	MYI	Class II	2002-03-27
K020862	I-Flow Elastomeric Pump	Halyard Health	MEB	Class II	2002-03-26
K020796	Card Iq Analysis II	GE Healthcare	JAK	Class II	2002-03-26
K020479	Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and Accessories	GE Healthcare	DQA	Class II	2002-03-26
K020159	Smith & Nephew Twinfix Ti Quick T	Smith & Nephew, Inc.	HWC	Class II	2002-03-26
K014303	Jostra Retrograde Cardioplegia Cannulae	Jostra AG	DWF	Class II	2002-03-26
K014262	Cosmed Quark C12/quark T12	Cosmed S.r.l.	DPS	Class II	2002-03-26
K014259	Sensititre Heamophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2002-03-26
K014253	Dermachiller 4	Paradigm Trex, LLC	GEX	Class II	2002-03-26
K014251	Ntero Hotrod System	Ntero Surgical, Inc.	GEI	Class II	2002-03-26
K014243	Bone-Lok Bioabsorbable Compression Anchor with Titanium Fixture , Model Bmcd-35-3040, Mbcd-35-4050	Triage Medical, Inc.	HWC	Class II	2002-03-26
K014236	Clinicon Waveguide Platform with Interconnect for Luxar Accessories	Clinicon Corp.	GEX	Class II	2002-03-26
K014030	1,25-Dihydroxyvitamin D125i Ria	Diasorin Inc.	MRG	Class II	2002-03-26
K013426	Moonray Mobile C-Arm	Simad S.r.l.	OXO	Class II	2002-03-26
K012852	Ex-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, Sts Versions	Optonol, Ltd	KYF	Class II	2002-03-26
K012406	Access Sequestration System	Interpore Cross Intl.	CAC	Class II	2002-03-26
K010744	Flowtron Universal, Model Ac600	Huntleigh Healthcare Ltd.	JOW	Class II	2002-03-26
K010131	Phd Personal Hemodialysis Instrument-1M101, Phd Water Pre-Treatment Kit-1W605,phd Hard Plumbing Kit-1W604, Phd Blood Tub	Aksys, Ltd.	KDI	Class II	2002-03-26
K004022	M3 (Mirco-Multileaf Collimator	Brainlab, Inc.	IYE	Class II	2002-03-26
K020870	Vitek 2 Antimicrobial Susceptibility Test Sytem for Sparfloxacin	bioMerieux, Inc.	LON	Class II	2002-03-25
K020256	Unicem	3M Espe AG Dental Products	EMA	Class II	2002-03-25
K011388	Zoll Pad	ZOLL Medical Corporation	MKJ	Class III	2002-03-25
K011378	Joe Lub Helmet Condom	Marketing Sales Concepts, Inc. (Msci)	HIS	Class II	2002-03-25
K011363	Joe Lube Condom	Marketing Sales Concepts, Inc. (Msci)	HIS	Class II	2002-03-25
K004009	3M Attest 290 Auto-Reader	3M Company	FRC	Class II	2002-03-25
K020596	Calibrating Material,cal-Pak, Cal & Slope Standards	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2002-03-23
K020580	X-Series Bi-Metric Hip Femoral Components	Zimmer GmbH	LPH	Class II	2002-03-22
K020037	Dried Gram Negative Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	2002-03-22
K014240	Pronto	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2002-03-22
K020737	Cat Active Wheelchair	Movingpeople.Net	IOR	Class I	2002-03-21
K020733	Pvs 1500 Sds	Precision Vascular Systems, Inc.	KRA	Class II	2002-03-21
K020635	Kodak Directview Cr 800 System, Catalog# 1268622; Kodak Directview Cr 900 System, Catalog# 1170976	Eastman Kodak Company	MQB	Class II	2002-03-21
K020558	Licox Cc1.g2 Brain Oxygen Catheter-Microprobe	Integra NeuroSciences	GWM	Class II	2002-03-21
K020557	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	ArthroCare Corporation	GEI	Class II	2002-03-21
K020522	Modification to Surgical Titanium Mesh System	Depuyacromed	MQP	Class II	2002-03-21
K020450	Validate Chem 8 Calibration Verification Test Set; Model 108	Maine Standards Co.	JJY	Class I	2002-03-21
K020180	Reliefband Device, Models Rb-Dl, Rb-El, Rb-Rl	Woodside Biomedical, Inc.	GZJ	Class II	2002-03-21
K020175	Urs-Ig (Glucose Test)	Teco Diagnostics	JIL	Class II	2002-03-21
K020091	Optilux 501	Kerr Corporation (Danbury)	EBZ	Class II	2002-03-21
K020007	Safyre Sling System	Promedon	OTN	Class II	2002-03-21
K020002	Model P-33, Battery Operated, Three Wheel, Power Scooter , Model P-33	Transworld Mobility Distribution, LLC	INI	Class II	2002-03-21
K020001	Pf-3, Battery Operated, Four Wheel, Power Scooter, Model Pf-3	Transworld Mobility Distribution, LLC	INI	Class II	2002-03-21
K014248	Dnd 202 Manual Urological Digital Needle Driver	Urogyn, Ltd.	KNA	Class II	2002-03-21
K014216	Secca System	Curon Medical, Inc.	GEI	Class II	2002-03-21
K014207	Reposable Instrument System, Models Mf001-Mf083	Aesculap Inc	GEI	Class II	2002-03-21
K014197	Synthes High Tibial Osteotomy Plate	Synthes (USA) Products LLC	HRS	Class II	2002-03-21
K014189	Odi Talon Intramedullary Hip Nail	Orthopedic Designs, Inc.	JDS	Class II	2002-03-21
K014139	Diabetes Assistant Software	Roche Diagnostics GmbH	CGA	Class II	2002-03-21
K012915	Dinamap Pro 1000 Monitor, Model 1000	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2002-03-21