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 1390 of 3531

510(k) clearances, page 1390 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040391	Total Bilirubin Reagent Set	Horiba Instruments Incorporated	CIG	Class II	2004-06-02
K033859	Barcoview Mgd 521M Digital Mammography Display	Barco NV Barcoview	LLZ	Class II	2004-06-02
K033489	Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known	Zimmer GmbH	MBH	Class II	2004-06-02
K041199	Medi-Pump Aspirator, Model 1615	Thomas Industries	BTA	Class II	2004-06-01
K041198	Nic36 Amplifier	EB Neuro S.p.A.	GWL	Class II	2004-06-01
K041188	Grand Work Plastics Products Co., Ltd., Synthetic Vinyl Patient Examination Gloves - Powdered	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-06-01
K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	HRX	Class II	2004-06-01
K040869	Export Catheter	Medtronic, Inc.	QEZ	Class II	2004-06-01
K040713	Modification to Braided Guiding Introducer System	Merit Medical Systems, Inc.	DYB	Class II	2004-06-01
K040659	Mccue Plc Energist Ultra Variable Pulsed Light System	Mccue PLC	GEX	Class II	2004-06-01
K040615	Compressar Supercomfort Disc and Strongarm Supercomfort System	Advanced Vascular Dynamics	DXC	Class II	2004-06-01
K040395	Central Telemetry System, Model Wep-4200A Series	Nihon Kohden America Inc	MHX	Class II	2004-06-01
K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2Ms, 740M-2Ms, 740-2Nl, 740M-2Nl, 740-2Nn, 740M-2Nn, 740-3Ms, 740M-3Ms	Cas Medical Systems, Inc.	MHX	Class II	2004-06-01
K032983	Sensitive Skin Antibacterial Bandages	Scivolution, Inc.	FRO	Unclassified	2004-06-01
K041358	Venoject Luer Adapter	Terumo Europe N.V.	JKA	Class II	2004-05-28
K041337	Pro Walker Ml-300 Foldable Wheelchair	Pro Walker, Inc.	IOR	Class I	2004-05-28
K041283	Procera Bridge Zirconia	Nobel Biocare AB	ELL	Class II	2004-05-28
K041217	Modification to Bone Graft Washer	Medtronic Sofamor Danek	KWQ	Class II	2004-05-28
K041118	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2004-05-28
K041117	Panalok Rc Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok Rc Quickanchor Pllus, Models 212132, 212732	DePuy Mitek, Inc.	JDR	Class II	2004-05-28
K041116	Super Quickanchor Plus	DePuy Mitek, Inc.	JDR	Class II	2004-05-28
K041115	Gii Quickanchor Plus	DePuy Mitek, Inc.	JDR	Class II	2004-05-28
K041114	Profemur Tapered Hip Stem	Wrightmedicaltechnologyinc	JDL	Class III	2004-05-28
K040964	Scorpio Total Knee System - Posterior Stabilized Tibial Inserts	Howmedica Osteonics Corp	JWH	Class II	2004-05-28
K040891	Kls Martin Ortho Anchorage System (Plates)	KLS-Martin L.P.	DZE	Class II	2004-05-28
K040758	Mgc Dau Control Sets: Primary, Clinical and Select	Microgenics Corporation	DIF	Class I	2004-05-28
K040664	Omnilight Vl-2004, Pl-2004, Dl-2004, and Wl-2004	Omnilight, Inc.	ILY	Class II	2004-05-28
K040552	Model 3100 Series Sheath Introducer Kits, Models 3110, 3130	Cryocor, Inc.	DYB	Class II	2004-05-28
K040544	Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062 and 1599-21-044 to -062	Depuy, Inc.	LPH	Class II	2004-05-28
K040293	Healthtest Heparin/platelet Factor 4 Antibody Assay	Akers Laboratories, Inc.	LCO	Class II	2004-05-28
K040265	Little Grafter Screw	Biocomposites, Ltd.	HWC	Class II	2004-05-28
K033971	Scorpio Total Knee System with Peri-Apatite Coating	Howmedica Osteonics Corp	MBH	Class II	2004-05-28
K033458	Bd Phoenix Automated Microbiology System - Confirmatory Esbl Test	Becton Dickinson & Co	LON	Class II	2004-05-28
K032644	Kolpexin Sphere	Adamed, Ltd.	HHW	Class II	2004-05-28
K032522	Tecres Spacer-K Temporary Knee Prosthesis	Exactech, Inc.	JWH	Class II	2004-05-28
K032170	Transneb Compressor W/nebulizer, Model 5000	Medical Industries America, Inc.	CAF	Class II	2004-05-28
K030474	Ph Buffering Plastic Applicator Tampon	Rostam, Ltd.	HEB	Class II	2004-05-28
K041275	Procera Abutment Octagon	Nobel Biocare Uas, Inc.	NHA	Class II	2004-05-27
K041270	CT Colonography II	General Electric Medical Systems	LLZ	Class II	2004-05-27
K041267	Cardiq Analysis III	General Electric Medical Systems	JAK	Class II	2004-05-27
K041227	Modification To:roche Diagnostics Precinorm Universal and Precipath Universal Control Sera	Roche Diagnostics GmbH	JJY	Class I	2004-05-27
K041160	Avon Extra-Small Patello-Femoral Replacement	Howmedica Osteonics Corp	KRR	Class II	2004-05-27
K040914	Polyvial/polypak, Contact Lens Case and Storage System Container for Ophthalmics	Exero Products, Inc.	LRX	Class II	2004-05-27
K040672	Porta Reflex	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2004-05-27
K040581	Medvizertm Vitelcare Patient Monitoring System	Vitel Net	DQA	Class II	2004-05-27
K040512	Limited Function Wl/otc-TENS Device, Model Wl-2103A, Wl-2203A, Wl-2203B and Wl-2401	Well-Life Healthcare Limited	GZJ	Class II	2004-05-27
K040411	Dri Oxycodone Assay	Microgenics Corporation	LAS	Class I	2004-05-27
K040090	Comppac 200Hd; Cs12 Power Supply (Aircraft/vechile); Ps11 Power Supply (Mains)	Pneupac, Ltd.	BTL	Class II	2004-05-27
K033704	Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters	Phoenix Biomedical Corp.	JXG	Class II	2004-05-27
K033663	Spinal Concepts Inc. Coda	Spinal Concepts, Inc.	MQP	Class II	2004-05-27