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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 794 of 3530

510(k) clearances, page 794 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133184	Ardis Interbody System	Zimmer Spine, Inc.	MAX	Class II	2014-01-30
K132770	Dome S10	NDS Surgical Imaging, LLC	LLZ	Class II	2014-01-30
K132758	Digital Electrocardiograph	Shenzhen Biocare Bio-Medical Equipment Co., Ltd.	DPS	Class II	2014-01-30
K132746	Nobelprocera Angulated Screw Channel Abutment Conical Connection	Nobel Biocare USA LLC	NHA	Class II	2014-01-30
K132643	UV Phototherapy	Xuzhou Kernel Medical Equipment Co Ltd	FTC	Class II	2014-01-30
K132474	Cardiovascular Pressure Measurement (Cpm) System, Navvus Catheter	Acist Medical Systems, Inc.	DXO	Class II	2014-01-30
K131833	Centurion Poct System	Orthofix SRL	KWP	Class II	2014-01-30
K131344	Powder Free Yellow Synthetic Vinyl Patient Examination Gloves	Shijiazhuang Wally Plastics Co., Ltd.	LYZ	Class I	2014-01-30
K130872	Cardiocel	Celxcel Pty, Ltd.	DXZ	Class II	2014-01-30
K133355	Cadwell Flex Eeg/psg	Cadwell Industries Inc	GWQ	Class II	2014-01-29
K133236	Tandemheart Femoral Venous Cannula Set	Cardiacassist, Inc.	DWF	Class II	2014-01-29
K133176	Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal	Alcon Laboratories	LPL	Class II	2014-01-29
K132721	Spiway Endonasal Access Guide	SPIWay, LLC	LYA	Class I	2014-01-29
K132163	Moorldls-Bi Laser Doppler Burns Imager	Moor Instruments Ltd.	DPT	Class II	2014-01-29
K131444	Ua-Cellular Complete	Streck LLC	JJW	Class I	2014-01-29
K131204	Advance Cs Coronary Sinus Infusion Catheter	Cook Inc.	DQY	Class II	2014-01-29
DEN120023	Given Pillcam Colon 2 Capsule Endoscopy System	Given Imaging Ltd.	PGD	Class II	2014-01-29
K133723	OTC Patch	Well-Life Healthcare Limited	NUH	Class II	2014-01-28
K133541	Emerge Medical Small and Large Non-Locking Fragment Plate System	Emerge Medical	HRS	Class II	2014-01-28
K131413	Xtrafix Small External Fixation System	Zimmer GmbH	KTT	Class II	2014-01-28
K131330	Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit	Gold Standard Diagnostics, LLC	LJM	Class II	2014-01-28
DEN130036	Prostate Immobilizer Rectal Balloon	Radiadyne	PCT	Class II	2014-01-28
K133986	1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible Array	Resonance Innovations, LLC	MOS	Class II	2014-01-27
K133785	Tritium Sternal Cable Plate System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	2014-01-27
K133354	Peri-Prosthetic Cable System	Zimmer GmbH	JDQ	Class II	2014-01-27
K133331	4D Integrated Treatment Console	Varian Medical Systems, Inc.	MUJ	Class II	2014-01-27
K133103	Aversion Pedicle Screw System	K7, LLC	MNI	Class II	2014-01-27
K132638	Dimension Creatinine (Cre2) Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	CGX	Class II	2014-01-27
K132444	Atama System	Monteris Medical Corp	MOS	Class II	2014-01-27
K131309	Sonopulse Compact 1Mhz, Sonopulse Compact 3Mhz	Ibramed Equipamentos Medicos	IMI	Class II	2014-01-27
K131244	Elecsys Ft4 II Assay, Elecsys Ft4 II Calset	Roche Diagnostics GmbH	CEC	Class II	2014-01-27
K140058	Atricure Cryo Module System	AtriCure, Inc.	GEH	Class II	2014-01-24
K133987	Captivator Ii,single-Use Polypectomy Snares	Boston Scientific Corporation	FDI	Class II	2014-01-24
K133881	Macy Catheter	Hospi Corporation	KNT	Class II	2014-01-24
K133728	Dimension Vista Creatinine (Cre2) Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	CGX	Class II	2014-01-24
K133726	Mega Soft Universal Patient Return Electrode	Megadyne Medical Products, Inc	GEI	Class II	2014-01-24
K133642	Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls, Collector; Rapidfret Integrated Work	Biophor Diagnostics, Inc.	DJG	Class II	2014-01-24
K133602	Add-Vantage Addaptor	Abbott Medical	LHI	Class II	2014-01-24
K133259	Ysio Max	Siemens Medical Solutions USA, Inc.	KPR	Class II	2014-01-24
K133013	Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute	Inventis SRL	ETY	Class II	2014-01-24
K132817	Kiva Vcf Treatment System	Benvenue Medical, Inc.	NDN	Class II	2014-01-24
K132815	Puregraft 50 System	Cytori Therapeutics, Inc.	MUU	Class II	2014-01-24
K132782	Carto3 Ep Navigation System, Version 3.2	Biosense Webster Inc	DQK	Class II	2014-01-24
K132616	Epad	Safeop Surgical, Inc.	GWF	Class II	2014-01-24
K132300	Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip, Epix Electrosurgical Probe J-Hook Tip, Re	Applied Medical Resources Corp	GEI	Class II	2014-01-24
K132057	Dynatron Peltier Thermostim Probe	Dynatronics Corp.	GXY	Class II	2014-01-24
K131910	Mpp	Marc Pro, Inc.	NUH	Class II	2014-01-24
K131500	Yasargil Aneurysm Clips and Clip Appliers	Aesculap Inc	HCH	Class II	2014-01-24
K131457	Fetal Ultrasonic Monitor and Accessories	Shenzhen Jumper Medical Equipment Co.,Ltd.	KNG	Class II	2014-01-24
K131307	Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2014-01-24