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 1353 of 3531

510(k) clearances, page 1353 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043307	Cranex D	Soredex Palodex Group Oy	EHD	Class II	2004-12-17
K043293	Mini-Gamma Camera, Models Mgc500-101U and Mgc500-301U	Acrorad Co., Ltd.	KPS	Class II	2004-12-17
K043181	Modification to Vertebron Scp Cervical Plate System	Vertebron, Inc.	KWQ	Class II	2004-12-17
K043177	Cleafil Dc Core Automix	Kuraray Medical, Inc.	EBF	Class II	2004-12-17
K043119	Amelogen Plus	Ultradent Products Inc.	EBF	Class II	2004-12-17
K043077	Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System	TORNIER Inc.	KWS	Class II	2004-12-17
K042943	Nouvag Ag - Vacuson 40 and Vacuson 60	Nouvag AG	BTA	Class II	2004-12-17
K042923	Md-6W Wireless Critical Data Viewer	The Microoptical Corporation	GCJ	Class II	2004-12-17
K042878	Flexitime Xtreme	Kulzer GmbH	ELW	Class II	2004-12-17
K042847	Systemp.cem	Ivoclar Vivadent, Inc.	EMA	Class II	2004-12-17
K042787	Is 40 Micromotor	Satelec	EFB	Class I	2004-12-17
K042783	Anspach Minimal Access Spinal Attachment (Masa) System	The Anspach Effort, Inc.	HBE	Class II	2004-12-17
K042734	Sjm Rigid Saddle Ring Model Rsar-(Size)	Abbott Medical	KRH	Class II	2004-12-17
K042676	Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay	Nichols Institute Diagnostics	DHA	Class II	2004-12-17
K042654	Protection Plus Earloop Procedure Mask	Safety-Med Products, Inc.	FXX	Class II	2004-12-17
K042638	Radiance Porcelain	Aurident, Inc.	EIH	Class II	2004-12-17
K042530	Conserve Plus Ha Acetabular Shells	Wrightmedicaltechnologyinc	KWA	Class III	2004-12-17
K042399	Modification to Short Introducer Sheath	Rex Medical LP	DYB	Class II	2004-12-17
K042385	Doc Band-Postop	Cranial Technologies, Inc.	MVA	Class II	2004-12-17
K042370	Torayguide Guidewire	Toray Industries (America), Inc.	DQX	Class II	2004-12-17
K042248	Kronus, Inc.'s Acetylcholine Receptor Antibody (Achrab) Assay Kit	Kronus Market Development Associates, Inc.	NST	Class II	2004-12-17
K042057	Infinity Electrotherapy System	Empi	LIH	Class II	2004-12-17
K041987	Cortrak	Viasys Medsystems	KNT	Class II	2004-12-17
K041619	Bio Check Whole Blood/plasma/sermon Model #801116	BioCheck Inc	MMI	Class II	2004-12-17
K040592	Cordis Steer-It Deflecting Tip Guidewire	Cordis US Corp.	DQX	Class II	2004-12-17
K040426	Trans1 Axial Fixation System	TranS1	KWQ	Class II	2004-12-17
K040049	The Reliance Endoscope Processing System	STERIS Corporation	NZA	Class II	2004-12-17
K040047	Polygraft Bgs; Bone Graft Substitute	Osteobiologics, Inc.	MQV	Class II	2004-12-17
K043258	Modified Tfx Medical Safety Needle with Introducer, Part No. T4634-02	Teleflex Medical	KNT	Class II	2004-12-16
K042805	Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile	Perusahaan Getah Asas Sdn. Bhd.	LZC	Class I	2004-12-16
K042349	EMG Model Sua01 Suction Unit	EMG Technology Co., Ltd.	JCX	Class II	2004-12-16
K042239	Flexiskin Powder Free Nitrile Examination Gloves, Non Sterile	Pt. Mandiri Inti Buana	LZA	Class I	2004-12-16
K041679	Cold Light; Cold Light Md; Gossamer Dermlight	Onyx Medical LLC	ILY	Class II	2004-12-16
K040270	Opusduo; Opusduo E; Opusduo Ec; Opus 20; Opus Spectrum	Lumenis Ltd	GEX	Class II	2004-12-16
K033266	Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools	Medical Imaging Applications, LLC	DQK	Class II	2004-12-16
K043350	Mistar, Model V3.2	Apollo Medical Imaging Technology Pty., Ltd.	LLZ	Class II	2004-12-15
K043333	Vitrea2, Version 3.7 Medical Image Processing System	Canon Medical Informatics, Inc.	LLZ	Class II	2004-12-15
K043153	Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments, Models Is1200 & Is1000	Intuitive Surgical, Inc.	NAY	Class II	2004-12-15
K043131	Torpicalgin	Zhermack S.p.A.	ELW	Class II	2004-12-15
K043098	Gerber Double Electric Breast Pump	Gerber Products Co.	HGX	Class II	2004-12-15
K043087	Somatom Care Contrast CT	Siemens Medical Solutions USA, Inc.	JAK	Class II	2004-12-15
K042863	Scenium	Siemens Molecular Imaging, Ltd.	KPS	Class II	2004-12-15
K042386	Direct Digitizer, Regius Model 190	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2004-12-15
K042379	Anemiapro Self-Screener	Biosafe Laboratories, Inc.	KHG	Class II	2004-12-15
K041406	Newport C250 Air Compressor Model C250	Newport Medical Instruments, Inc.	BTI	Class II	2004-12-15
K031425	Gentlewaves LED Photomodulation Device	Light Bioscience, LLC	GEX	Class II	2004-12-15
K043337	Arthrex Bio-Corkscrew Ft Suture Anchor	Arthrex GmbH	HWC	Class II	2004-12-14
K043190	Scalloped Endopore Endosseous Dental Implant System	Innova Life Sciences Corp.	NHA	Class II	2004-12-14
K042962	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2004-12-14
K042820	Systemp.c&b Plus	Ivoclar Vivadent, Inc.	EBG	Class II	2004-12-14