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 1410 of 3531

510(k) clearances, page 1410 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K034054	Pro Series Couch Software, Model Mt-Pro100	Medtec LLC	JAI	Class II	2004-02-20
K034015	Earloop Procedure Mask	Medipack Medical Packaging Mfg. Co.	FXX	Class II	2004-02-20
K033968	Hansson Pin System	Howmedica Osteonics Corp	HTY	Class II	2004-02-20
K033962	Lad (Epiture Easytouch), Model Lad-08	Norwood Abbey, Ltd.	GEX	Class II	2004-02-20
K033950	Dorc Vitrectomy Lenses, Model 1284 Series	Dutch Ophthalmic Research Center (D.O.R.C.)	HJK	Class II	2004-02-20
K033878	Ace Antegrade Retrograde Humeral Nail System	Depuy Ace	HSB	Class II	2004-02-20
K033821	Kodak Dryview 8900 Laser Imager Mammography Accessory	Eastman Kodak Company	LMC	Class II	2004-02-20
K033809	Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models Df113. Dc49d	Siemens Healthcare Diagnostics Inc.	KLR	Class II	2004-02-20
K033806	Ace Proximal Humeral Nail System	Depuy Ace	HSB	Class II	2004-02-20
K033805	Synthes (USA) 3.5 / 4.5 Mm Lcp Metaphyseal Plates	Synthes (USA) Products LLC	LXT	Class II	2004-02-20
K033731	Axsym Cortisol Assay	Fujirebio Diagnostics, Inc.	JFT	Class II	2004-02-20
K033700	Mammotome Ex Hand Held System	Ethicon Endo-Surgery Inc	KNW	Class II	2004-02-20
K033690	Trophypan and Trophypan C	Trophy Radiologie	EHD	Class II	2004-02-20
K033677	Brain Perfusion Option	Philips North America LLC	JAK	Class II	2004-02-20
K033676	Palindrome 14.5 Fr Chronic Hemodialysis Catheter	Kendall	MSD	Class II	2004-02-20
K033466	Color Lcd Display, Model Radiforce R22	Eizo Nanao Corporation	LLZ	Class II	2004-02-20
K032979	Philips Spo2 Reusable Sensors, Model Nos. M1191t, M1192t, and M1193t	Philips North America LLC	DQA	Class II	2004-02-20
K032443	Digital Angiography System Digitex Safire	Shimadzu Corp.	IZI	Class II	2004-02-20
K032394	Stryker Spine Oasys System	Howmedica Osteonics Corp	MNI	Class II	2004-02-20
K032350	Infrared Sciences Breastscan Ir System	Infrared Sciences Corp.	LHQ	Class I	2004-02-20
K032064	Theken Cpod/lpod Vertebral Body Replacement System	Theken Surgical,Llc	MQP	Class II	2004-02-20
K032056	Bilevel CPAP, Model 9055 Series	Sunrise Medical, Inc.	BZD	Class II	2004-02-20
K031774	Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses	Westcon Contact Lens Co., Inc.	LPL	Class II	2004-02-20
K031051	Smartep-Assr, Model M811007	Intelligent Hearing Systems Corp.	GWJ	Class II	2004-02-20
K040254	Integris 3D-Ra, Release 4.2	Philips North America LLC	LLZ	Class II	2004-02-19
K034010	Gelsoft Plus Ers	Vascutek, Ltd.	DSY	Class II	2004-02-19
K033759	C2 Nasal Mask	Respironics, Inc.	BZD	Class II	2004-02-19
K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V	Masimo Corporation	DQA	Class II	2004-02-19
K032612	Ir Forehead Thermometer, Model Hv-T36	Oriental Inspiration Limited	FLL	Class II	2004-02-19
K032551	Masimo Lnop-Tf-I Resuable Transflectance Sensor	Masimo Corporation	DQA	Class II	2004-02-19
K040167	Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-02-18
K040150	Modification to Medamicus Flowguard Peelable Introducer	Greatbatch Medical	DYB	Class II	2004-02-18
K040139	Endobionics Microsyringe (Usyringe) Infusion Catheter	Endobionics, Inc.	KRA	Class II	2004-02-18
K040113	Sandman Sd20 Amplifier	EB Neuro S.p.A.	GWL	Class II	2004-02-18
K040104	Cobra Adhere Surgical System, Model M00415977c0	Boston Scientific Corporation	GEI	Class II	2004-02-18
K040020	C.t.m. Power Chair, Model Hs-1000	C.T.M. Homecare Product, Inc.	ITI	Class II	2004-02-18
K034039	Sis Plastic Surgery Matrix	Cook Biotech, Inc.	FTM	Class II	2004-02-18
K033978	Adam	Astro-Med, Inc.	GWQ	Class II	2004-02-18
K033633	Vascon Polaris Guiding Catheter	Vascon, LLC	DQY	Class II	2004-02-18
K033517	Spinal Concepts Inc. Cadence and Traxis	Spinal Concepts, Inc.	MQP	Class II	2004-02-18
K033354	Femtec Laser Microkeratome	20/10 Perfect Vision Optische Gerate GmbH	GEX	Class II	2004-02-18
K033223	Zimmer Ortho Guidance Systems- Hip Instruments	Zimmer GmbH	HAW	Class II	2004-02-18
K033205	Manoa Breast Biopsy System	Manoa Medical, Inc.	GEI	Class II	2004-02-18
K031859	Cap Great Toe Resurfacing Hemi-Arthroplasty Implant	Arthrosurface, Inc.	KWD	Class II	2004-02-18
K040248	Modification to Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2004-02-17
K040239	Supraflow Console	Neomedix Corp.	BTA	Class II	2004-02-17
K040227	Qlab Quantification Software	Philips North America LLC	LLZ	Class II	2004-02-17
K033909	Wavemax Balloon-Expandable Transhepatic Biliary Stent System	Abbott Medical	FGE	Class II	2004-02-17
K033768	Altus Medical Optional Infrared Handpiece	Altus Medical, Inc.	ILY	Class II	2004-02-17
K033047	Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device	Acon Laboratories, Inc.	DJG	Class II	2004-02-17