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 1382 of 3531

510(k) clearances, page 1382 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041575	Fenzian Treatment System	Eumedic Limited	GZJ	Class II	2004-07-16
K041564	Q-Cap Needle-Free Reconstitution 13Mm Vial Adapter, Model 6100-01	Bioject Medical Technologies, Inc.	LHI	Class II	2004-07-16
K041354	Varelisa Gliadin Iga Antibodies Model #19848/19896	Sweden Diagnostics (Germany) GmbH	MST	Class II	2004-07-16
K041344	Open Bore Syringe	Isotis NV	FMF	Class II	2004-07-16
K041178	Empower Transfer Set, (Cat. No. 7725)	E-Z-EM, Inc	FPK	Class II	2004-07-16
K041111	Magnetom C! Mr System	Siemens Medical Solutions USA, Inc.	LNH	Class II	2004-07-16
K041042	Split Septum Injection Sites	Fresenius Medical Care Renal Therapies Group, LLC	FPA	Class II	2004-07-16
K040896	Modification to Encompass	Heartlab, Inc.	LLZ	Class II	2004-07-16
K040851	Medpor Attractor Magnetic Coupling System	Porex Surgical, Inc.	HPZ	Class II	2004-07-16
K040554	Actigraph, Model Am7164-2.2 and Actigraph with Extended Memory, Model Am71256	Manufacturing Technology, Inc.	GWQ	Class II	2004-07-16
K040466	Bindazyme Human Anti Tissue Transglutaminase Iga and Igg Eia Diagnostic Test Kits	The Binding Site	MVM	Class II	2004-07-16
K031395	Merlin Resuscitator	Merlin Medical Limited	BTM	Class II	2004-07-16
K041789	Noninvasive Blood Pressure Monitor, Models Md-880B and Md-900T	Meditec Co., Ltd.	DXN	Class II	2004-07-15
K041773	Oxygen Medicels, Citicels	City Technology Limited	CCL	Class II	2004-07-15
K041745	Vinyl Examination Gloves, Powder Free, Green Color	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	2004-07-15
K041473	Var-Plus (Vortran Automatic Resuscitator), Model Pcm	Vortran Medical Technology 1, Inc	BTL	Class II	2004-07-15
K041362	Resmed Hospital Full Face Mask	ResMed Corp	BZD	Class II	2004-07-15
K041225	Synthetic (Yellow) Vinyl Patient Examination Gloves-Powered	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-07-15
K041148	Pocone Infrared Spectrophotometer	Otsuka Pharmaceutical Co., Ltd.	MSQ	Class I	2004-07-15
K041084	Clip-on Spacer 20%; 40%; 50%	Serono, Inc.	FMF	Class II	2004-07-15
K040649	Kendall Scd Express Kambia Thigh Length Tearaway Sleeve	Tyco Healthcare	JOW	Class II	2004-07-15
K041753	Aeskulisa Ena 6 S	Aesku Diagnostics	LLL	Class II	2004-07-14
K041014	Tsh-Ctk-3 Irma	Diasorin Inc.	JLW	Class II	2004-07-14
K040980	Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix Dr Putty, Ignite Scaffold, Models 860C, 86Xc, 86Dr, 860D, 860T	Wrightmedicaltechnologyinc	MQV	Class II	2004-07-14
K040756	The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx	Implex Corp.	FTM	Class II	2004-07-14
K040678	Eusure Blood Glucose Monitoring System	Eumed Biotechnology Co., Ltd.	NBW	Class II	2004-07-14
K041763	Shimadzu Mobile X-Ray System Mux-100D Series	Shimadzu Corp.	IZL	Class II	2004-07-13
K041761	Rapidiacolon	Infinitt Co., Ltd.	LLZ	Class II	2004-07-13
K041737	5M Monochrome Digital Mammography Lcd Monitor Me511l (Mdl2105a)	Totoku Electric Co., Ltd.	LLZ	Class II	2004-07-13
K041348	Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra	Abbott Medical	JOH	Class II	2004-07-13
K041221	Accu-Stat Home Drug Test Cup for Maijuanna (Thc), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Mamp), Ecstasy	Accu-Stat Diagnostics, Inc.	LDJ	Class II	2004-07-13
K040782	N-Vivo Calcium Score on Ia Chassis Release, Model Release X.xx	Image Analysis, Inc.	JAK	Class II	2004-07-13
K040382	Cranex Basex D or Cranex Excel D	Soredex Palodex Group Oy	EHD	Class II	2004-07-13
K040231	Inteliport Occluding Device	Alcon, Inc.	LZU	Unclassified	2004-07-13
K033106	Captia Hsv 2 Igg Type Specific Elisa Kit	Trinity Biotech USA	MYF	Class II	2004-07-13
K033105	Captia Hsv 1 Igg Type Specific Elisa Kit	Trinity Biotech USA	MXJ	Class II	2004-07-13
K031431	Bawmed Rescue Mask	Bawmed UK	CBP	Class II	2004-07-13
K041574	Cpi Lead Adapters, Models 6017, 6018 and 6020	Boston Scientific Corporation	DTD	Class II	2004-07-12
K041413	Xps 3000 System	Medtronic Xomed, Inc.	ERL	Class II	2004-07-12
K041153	Sharpsaway II Locking Disposable Cup	Arrow Intl., Inc.	FMI	Class II	2004-07-12
K040362	Diapharma Factor X Kit	Diapharma Group, Inc.	GJT	Class II	2004-07-12
K033858	Temporary Bipolar Myocardial Pacing Wire	Alto Development Corp	LDF	Class II	2004-07-12
K033739	Physician Industries' Durameter Syringe	Physician Industries, Inc.	FMF	Class II	2004-07-12
K033448	Electro-Optical Air Sterilizer with Ionizer	John Mfg., Ltd.	FRA	Class II	2004-07-12
K041738	Baxter Infusor Sv (Small Volume); Baxter Infusor Lv (Large Volume)	Baxter Healthcare Corporation	FRN	Class II	2004-07-09
K041645	Dds-Zr	Charles Scharf	EIH	Class II	2004-07-09
K041586	Profemur S Hip Stem	Wrightmedicaltechnologyinc	JDL	Class III	2004-07-09
K041454	Kyphx Xpander Inflatable Bone Tamps Model#ko8a,ko9a,k13a	Medtronic, Inc.	HRX	Class II	2004-07-09
K041391	Freeform Blue Powder-Free Nitrile Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	2004-07-09
K041321	Veroscope Optical Veress Cannula & Dilation Tube System	Richard Wolf Medical Instruments Corp.	HET	Class II	2004-07-09