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 1421 of 3531

510(k) clearances, page 1421 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032909	Thai Nippon Extra Strength Male Latex Condom	Thai Nippon Rubber Industry Co., Ltd.	HIS	Class II	2003-12-16
K032741	Epochxp Neurological Workstation,epochxp Lite Neurological Workstation	Axon Systems, Inc.	GWF	Class II	2003-12-16
K032469	Aeskulisa Ana 8Pro	Aesku, Inc.	LLL	Class II	2003-12-16
K032424	Lotus	SRA Developments Ltd	LFL	Unclassified	2003-12-16
K033748	Trident Resection Ablator	Linvatec Corporation	GEI	Class II	2003-12-15
K033740	Lorenz Sternal Closure System	Biomet Microfixation	HWC	Class II	2003-12-15
K033701	Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact Lenses	Alcon Laboratories	MVN	Class II	2003-12-15
K033631	Modification to Coatest Factor VIII	Instrumentation Laboratory Co.	GGP	Class II	2003-12-15
K033624	Pacs Software Solution 2003	Canon Medical Components U.S.A., Inc.	LLZ	Class II	2003-12-15
K033604	Tringa Ultrasound Imaging System, Model 50L	Pie Medical	IYO	Class II	2003-12-15
K033348	Zilver 518 Biliary Stent	Cook Inc.	FGE	Class II	2003-12-15
K033322	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNH	Class II	2003-12-15
K033306	Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators	Roche Diagnostics GmbH	DKB	Class II	2003-12-15
K032955	Automove, Model Am800	Danmeter A/S	IPF	Class II	2003-12-15
K032902	Subtalar Arthrorisis Implant	Nexa Orthopedics, Inc.	HWC	Class II	2003-12-15
K032679	Aequalis Shoulder Fracture System	TORNIER Inc.	KWS	Class II	2003-12-15
K032422	Eusol-C	Al.chi.mi.a. SRL	LYX	Unclassified	2003-12-15
K032171	Accusoft	Direx Systems Corp.	IYE	Class II	2003-12-15
K033752	Bruno Electra-Ride Stairway Elevator System. Model Sre-1540	Bruno Independent Living Aids, Inc.	ILK	Class II	2003-12-12
K033735	Vantage Pro Attenuation Correction Device	Philips North America LLC	KPS	Class II	2003-12-12
K033640	Siroson L and Sirosonic L Ultrasonic Scalers	Sirona Dental Systems GmbH	ELC	Class II	2003-12-12
K033583	Progreat	Terumo Medical Corp.	DQO	Class II	2003-12-12
K033562	Fastrac Gastric Access Port Kit	C.R. Bard Inc	KNT	Class II	2003-12-12
K033404	Liquichek Urine Toxicology Control (Confirmatory Series)	Bio-Rad	DIF	Class I	2003-12-12
K033398	Laryngeal Augmentation Implant	Bioform, Inc.	MIX	Class II	2003-12-12
K033366	Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455	Bio-Rad	DIF	Class I	2003-12-12
K033299	Acon Mamp One Step Methamphetamine Test Strip and Test Device	Acon Laboratories, Inc.	LAF	Class II	2003-12-12
K033298	Spo2.com Oximetry Sensors, Multiple Models	Masimo Corporation	DQA	Class II	2003-12-12
K033234	Immulite 2500 Automated Immunoassay Analyzer	Siemens Healthcare Diagnostics Inc.	DHA	Class II	2003-12-12
K033230	Tracers Ta Bone Cement Opacifier, Model Tcr-Ta	Parallax Medical, Inc.	MYU	Class II	2003-12-12
K033166	Kacey Insulin Syringe	Kacey, Inc.	FMF	Class II	2003-12-12
K033063	Mission Controls	DIAMOND DIAGNOSTICS Inc	JJS	Class I	2003-12-12
K032952	Aiact Kit	Sienco, Inc.	JBP	Class II	2003-12-12
K032866	Clarity Pet	Shared P.E.T. Imaging, LLC	KPS	Class II	2003-12-12
K032104	Amniolens	Bio-Tissue, Inc.	NQB	Class II	2003-12-12
K032102	Vertelink Kobra Spinal Fixation System	Vertelink Corporation	KWQ	Class II	2003-12-12
K031812	Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03	Vascular Control Systems, Inc.	DXC	Class II	2003-12-12
K031169	Motility Visualization System	Sierra Scientific Instruments, Inc.	FFX	Class II	2003-12-12
K033714	Mvr 1200 Pc: Sorin Monolyth Venous Reservoir 1200 Pc with Phosphorylcholine Coating	Dideco S.p.A.	DTN	Class II	2003-12-11
K033708	Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System	Intra Luminal Therapeutics, Inc.	DQX	Class II	2003-12-11
K033681	Glidesheath	Terumo Corp.	DYB	Class II	2003-12-11
K033680	M2376a Philips Device Link System	Philips North America LLC	MWI	Class II	2003-12-11
K033641	Smarxt Vvr4000i Plus Filtered Hardshell Venous Reservoir, Model 439914800	LivaNova USA, Inc.	DTN	Class II	2003-12-11
K033600	Infinity Gammaxl	Draeger Medical Systems, Inc.	MHX	Class II	2003-12-11
K033424	Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models Hvt100, Adt1001, Adt1002	Transonic Systems Inc	DPW	Class II	2003-12-11
K032846	Spectra Pulsed Diode Laser, Model Dr-1	Spectragenics, Inc.	GEX	Class II	2003-12-11
K032835	H/s Catheter Set	Biomerics	LKF	Class II	2003-12-11
K032268	Mbcp	Biomatlante	MQV	Class II	2003-12-11
K032205	Radiancy Acne System with Cleartouch Light Unit Assembly	Radiancy (Israel), Ltd.	GEX	Class II	2003-12-11
K031612	Alt Laser, Model Vtr 75	Avicenna Laser Technology, Inc.	ILY	Class II	2003-12-11