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 1223 of 3531

510(k) clearances, page 1223 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062755	Ikoniscope Oncofish Bladder Test System	Ikonisys, Inc.	JOY	Class II	2007-01-04
K062675	Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series	Gemore Technology Co., Ltd.	GXY	Class II	2007-01-04
K061782	Gambro Posiclear	Gambro Services, Inc.	FIP	Class II	2007-01-04
K063843	Apexnrg Xfr	Medicnrg, Ltd.	LQY	Unclassified	2007-01-03
K063058	Arthrex Anatoemic Phalangeal Prosthesis	Arthrex GmbH	KWD	Class II	2007-01-03
K062968	Lapman Laparoscope Manipulator and Accessories, Model 900-200 Series	Medsys, S.A.	GCJ	Class II	2007-01-03
K062896	V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; Vs3000, Vp0600, Vd0600	Sanarus Medical, Inc.	GEH	Class II	2007-01-03
K062544	Ar1000 Ultrasonic Wound Therapy System	Arobella Medical, LLC	LFL	Unclassified	2007-01-03
K062318	Biotop Hooksafe U-100 Insulin Syringe, Models 0.5Cc/ml and 1Cc/ml	Biotop Technology Co., Ltd.	MEG	Class II	2007-01-03
K062289	Bonart Art-L3 LED Curing Light	Bonart Co. Ltd.	EBZ	Class II	2007-01-03
K061208	Lifecell Dural Substitute Matrix	LifeCell Corp	GXQ	Class II	2007-01-03
K063612	Modification to Health Buddy Appliance	Health Hero Network, Inc.	DRG	Class II	2006-12-29
K063140	Rainbow Adhesive Co-Oximetry Sensors	Masimo Corporation	DQA	Class II	2006-12-29
K062905	Nio Fusion 4Mp; Mdnc 4130	Barco N.V.	LLZ	Class II	2006-12-29
K062787	Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01	Phadia AB	MVM	Class II	2006-12-29
K063276	Clinitek Advantus, Model 1420	Medrad, Inc.	JIL	Class II	2006-12-28
K063206	Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High	Siemens Healthcare Diagnostics Inc.	LPS	Class II	2006-12-28
K063164	Vitros Chemistry Products Thc Reagent, Calibrator Kit 30, Fs Calibrator 1, and Dat Performance Verifiers I, II, III, IV	Ortho-Clinical Diagnostics, Inc.	LDJ	Class II	2006-12-28
K062788	Collimator, Model M-38	Umi International	KPW	Class II	2006-12-28
K062652	Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor	Tanita Corporation of America	MNW	Class II	2006-12-28
K053218	Dbx Demineralized Bone Matrix Putty/paste/mix	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2006-12-28
K063643	Modification to Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program and Total Ghb Program	Bio-Rad Laboratories Inc., Clinical Systems Divisi	LCP	Class II	2006-12-27
K063244	Arc Surgical Bone Reduction Screw	Arc Surgical, LLC	HWC	Class II	2006-12-27
K063225	Metaizeau Nailing System	Howmedica Osteonics Corp	HSB	Class II	2006-12-27
K063074	Candela 3630 Laser System	Candela Corporation	GEX	Class II	2006-12-27
K063017	Aesculap Sternumfix Sternal Closure System	Aesculap Inc	JDQ	Class II	2006-12-27
K063009	Flexigrip Sternal Closure System, Model Fg0200 Through Fg0400 (None Sizes)	Praesidia S.r.l.	HRS	Class II	2006-12-27
K062555	Ebsensor Blood Glucose Monitoring System, Model Eb-G	Visgeneer, Inc.	NBW	Class II	2006-12-27
K062355	Ena Cem	Micerium S.p.A.	EMA	Class II	2006-12-27
K062115	Carbon Dioxide Monitor, Model Olg-2800A	Nihon Kohden America Inc	CCK	Class II	2006-12-27
K061676	Rigidometer, Model Dir-4U	Uroan 21	LIL	Unclassified	2006-12-27
K063628	Centricity Radiology Ra600, Cardiology Ca1000 and Digital Hardcopy	GE Healthcare	LLZ	Class II	2006-12-26
K063613	Modification to Terumo Syringe With/without Needle	Terumo Medical Corp.	FMF	Class II	2006-12-26
K063459	Cranex Novus	Soredex Palodex Group Oy	MUH	Class II	2006-12-26
K063382	Hdr CT Compatible Split Ring Applicator	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2006-12-26
K063262	Amx4-50 and Amx4-31 Mobile Digital Diagnostic Radiographic Systems	Virtual Imaging, Inc.	IZL	Class II	2006-12-26
K063143	Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators	Ortho-Clinical Diagnostics, Inc.	LFX	Class II	2006-12-26
K062924	Stratus Cs Acute Care Cardiophase Hscrp Testpak	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2006-12-26
K062785	Ltd Polyaxial Fixation System	Us Spine	KWP	Class II	2006-12-26
K062583	Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01	Phadia AB	MVM	Class II	2006-12-26
K062265	CT Expres III Contrast Media Delivery System	Swiss Medical Care S.A.	IZQ	Class II	2006-12-26
K061578	Ssp Vertebral Body Replacement	Specialty Spine Products, LLC	MQP	Class II	2006-12-26
K060852	Mooncup	Mooncup Limited	HHE	Class II	2006-12-26
K060416	Obelisc Vertebral Body Replacement Device	Ulrich GmbH & Co. KG	MQP	Class II	2006-12-26
K063551	Aequalis Humeral Plate	TORNIER Inc.	KTT	Class II	2006-12-22
K063543	Cobas Integra Bilirubin Special and Roche/hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226	Roche Diagnostics GmbH	CIG	Class II	2006-12-22
K063484	Patient Data Handler & Devices (Pdh&d)	Intermed Advisors, Inc.	DRG	Class II	2006-12-22
K063474	Electric Powered Wheelchair Model-Mini (P14)	Imc-Heart Way LLC	ITI	Class II	2006-12-22
K063395	O&p Bivalve Cranial Molding Helmet	Orthotic & Prosthetic Lab, Inc.	MVA	Class II	2006-12-22
K063381	CT Compatible F/s/d Applicators	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2006-12-22