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 1370 of 3531

510(k) clearances, page 1370 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042251	Bayer Advia 2120 Hematology Analyzer with Autoslide System	Medrad, Inc.	GKZ	Class II	2004-09-17
K042235	Orion Anterior Cervical Plating System	Medtronic Sofamor Danek	KWQ	Class II	2004-09-17
K042146	Robocouch Patient Support System	Accuray Incorporated	JAI	Class II	2004-09-17
K042145	Ready-Heat Blanket	Techtrade LLC	KME	Class I	2004-09-17
K042085	Crono F	Cane S.r.l.	FRN	Class II	2004-09-17
K042041	Xplorer 1600	Imaging Dynamics Company, Ltd.	MQB	Class II	2004-09-17
K041894	Orthofiber	Cp Medical	GAT	Class II	2004-09-17
K041074	Bd Facscanto with Bd Facsanto Software	Becton, Dickinson and Company, BD Biosciences	GKZ	Class II	2004-09-17
K040533	Ez Huber Safety Infusion Set	PFM Medical GmbH	FPA	Class II	2004-09-17
K033543	Narcotrend, Model Compact 4.0	Mt Monitortechnik GmbH & Co. KG	OLW	Class II	2004-09-17
K042429	The Prodigy System Dental Implants	BioHorizons Implant Systems Inc	DZE	Class II	2004-09-16
K042338	Coronary Peripheral and Renal Steerable Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2004-09-16
K042326	Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner	Ultrasonix Medical Corporation	IYN	Class II	2004-09-16
K042310	Ortho-Pro Cannulated Bone Screws	Ortho-Pro, LLC	HWC	Class II	2004-09-16
K042295	Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020	Linvatec Biomaterials, Ltd.	HWC	Class II	2004-09-16
K042281	Modification to Access Hypersensitive Htsh Assay	Siemens Healthcare Diagnostics Inc.	JLW	Class II	2004-09-16
K042244	Bone-Lok Mvp Cortical-Cancellous Compression Device	Triage Medical, Inc.	HWC	Class II	2004-09-16
K042238	Cashmere Polymer Coated Powder Free Nitrile Examination Gloves	Seal Polymer Industries Bhd.	LZA	Class I	2004-09-16
K042237	Ebi Periarticular Plating System	Ebi, LLC	HRS	Class II	2004-09-16
K042223	Xltek Connex Ip Headbox, Model 1054	Excel Tech., Ltd.	OMB	Class II	2004-09-16
K042195	Synchron Systems Hdl Cholesterol (Hdl), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/a16747	Siemens Healthcare Diagnostics Inc.	LBS	Class I	2004-09-16
K042072	Callos Cmf Bone Void Filler	Skeletal Kinetics, LLC	GXP	Class II	2004-09-16
K042030	Hyprocure Subtalar Implant System	Graham Medical Technologies, LLC	HWC	Class II	2004-09-16
K041991	Aspirex - Bone Marrow Aspirate Kit	IsoTis OrthoBiologics, Inc.	FMF	Class II	2004-09-16
K041989	Sintea Biotech Anterior Plate System, Model Acp.xx.t5.x	Sintea Biotech, Inc.	KWQ	Class II	2004-09-16
K041822	Acon Amp 300 One Step Amphetamine Test Strip and Device	Acon Laboratories, Inc.	DKZ	Class II	2004-09-16
K041751	Compression Anastomosis Clip (Cac)	Niti Medical Technologies, Ltd.	FZP	Class II	2004-09-16
K041663	Allomatrix Tcp, Allomatrix W/caso4 Filled Tcp, and Allomatrix Plus Cbm	Wrightmedicaltechnologyinc	MQV	Class II	2004-09-16
K041592	Coral Spinal System	Theken Surgical,Llc	KWP	Class II	2004-09-16
K041535	Lsc Lifestand Compact	Lifestand	IPL	Class II	2004-09-16
K041437	Maxitex Latex Neuro Pf Surgical Glove Powderfree	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	2004-09-16
K041021	RF Introduction Cannula	Epimed International, Inc.	GXI	Class II	2004-09-16
K040904	Philips Heartstart Home Defibrillator, Model M5068a	Philips North America LLC	NSA	Class III	2004-09-16
K040591	Duet System	Bioview	JOY	Class II	2004-09-16
K040377	Rii Infrared Ear Thermometer, Models Thxxn Series	Radiant Innovation Inc.	FLL	Class II	2004-09-16
K033599	Onsi -56 (Onsifocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens	The Lagado Corp.	HQD	Class II	2004-09-16
K033570	Medcomp T-3	Medcomp	NIE	Class II	2004-09-16
K042289	Mdi Ortho	Imtec Corp.	DZE	Class II	2004-09-15
K042249	Cls Spotorno Stem	Centerpulse Orthopedics, Inc.	LZO	Class II	2004-09-15
K042242	Alden Hp (Hioxifilcon B) Sphere & Toric Soft Contact Lenses	Alden Optical Labs., Inc.	LPL	Class II	2004-09-15
K042214	Powder-Free Non-Sterile Vinyl Examination Gloves	Shandong Perfect Plastic Co., Ltd.	LYZ	Class I	2004-09-15
K042194	Attain Select 6238Tel Guide Catheter Set for Left-Heart Delivery	Medtronic, Inc.	DQY	Class II	2004-09-15
K042020	Spectra Tissue Spectrometer System (Inspectra)	Hutchinson Technology, Inc.	MUD	Class II	2004-09-15
K041954	Disposable Monitoring Electrodes	Shanghai Intco Electrode Manufacturing Co Ltd	DRX	Class II	2004-09-15
K041862	Cd Horizon Spinal System	Medtronic Sofamor Danek	KWP	Class II	2004-09-15
K041206	Epitome System	Gebauer Medizintechnik GmbH	HNO	Class I	2004-09-15
K040942	Vst3	Biowatch Medical, Inc.	DXH	Class II	2004-09-15
K033634	Epsilon Metasul 32Mm Acetabular Inserts, Standard and Hooded	Centerpulse Orthopedics, Inc.	KWA	Class III	2004-09-15
K042389	Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera	Roche Diagnostics GmbH	JJY	Class I	2004-09-14
K042328	Somatom Spirit	Siemens Medical Solutions USA, Inc.	JAK	Class II	2004-09-14