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 1406 of 3531

510(k) clearances, page 1406 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K034046	Rnk Telephonic Stethoscope, Model Tr-1	Rnk Products, Inc.	DQD	Class II	2004-03-10
K034000	Vitalab Triglycerides Reagent and Vitalab Calibrator	Clinical Data, Inc.	CDT	Class I	2004-03-10
K033921	Ammonia-L3k Assay, Catalogue Number 233-10	Sekisui Diagnostics P.E.I. Inc.	JIF	Class I	2004-03-10
K033880	Electro-Lube	Mectra Labs, Inc.	GEI	Class II	2004-03-10
K033841	Resmed S8 Prime CPAP System	ResMed Corp	BZD	Class II	2004-03-10
K033549	Starlux Pulsed Light System	Palomar Medical Products, Inc.	GEX	Class II	2004-03-10
K033518	Lotus Pulmonary Function Filter, Models Cpf 101, Cpf 102, Cpf 103	Custom Plastic Products	BZG	Class II	2004-03-10
K033080	Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter	Abbott Medical	CAZ	Class II	2004-03-10
K032932	Direct Hdl-Cholesterol Liquid Color; Direct Hdl/ldl-Cholesterol Calibrator	Stanbio Laboratory	LBS	Class I	2004-03-10
K032885	Vidaport Intraosseous Infusion System	Teleflex Medical	FMI	Class II	2004-03-10
K032803	Datex-Ohmeda S/5 Avance Anesthesia System	GE Healthcare	BSZ	Class II	2004-03-10
K030920	Pogs 33	On Site Gas Systems Inc.	CAW	Class II	2004-03-10
K030797	S7 Elite CPAP System with Somnotraxx System; Autoset Spirit CPAP System with Somnotraxx System	ResMed Corp	BZD	Class II	2004-03-10
K040502	Sonoline Ebisu Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYO	Class II	2004-03-09
K040456	Fleboset Multiple	Laboratorios Grifols, S.A.	LHI	Class II	2004-03-09
K040349	Modification to Hrw-127 Wrist Array Coil	Mri Devices Corp.	MOS	Class II	2004-03-09
K040348	Modification to Hnc-127-Int Neurovascular Array Coil	Mri Devices Corp.	MOS	Class II	2004-03-09
K040347	Siremobil ISO-C 3D	Siemens Medical Solutions USA, Inc.	OXO	Class II	2004-03-09
K040302	Versapoint Resectoscopic System	Gynecare, A Div. of Ethicon, Inc.	HIH	Class II	2004-03-09
K040134	Therilink Bone Void Filler	Therics, Inc.	MQV	Class II	2004-03-09
K040001	Steerable Stylet	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	DRB	Class II	2004-03-09
K034059	Sectra Angiography Package and Sectra Cardiology Package	Sectra AB	LLZ	Class II	2004-03-09
K034057	Lacrytest	Adiatec SA	DGC	Class II	2004-03-09
K033967	Telethermographic Camera, Series a, E, S and P	Flir Systems	LHQ	Class I	2004-03-09
K033892	Ultraflex Infusion Set	Disetronic Medical Systems	FPA	Class II	2004-03-09
K033861	Bd Probetec Et Legionella Pneumophila (Lp) Amplified DNA Assay	Becton Dickinson & Co	LQH	Class II	2004-03-09
K033807	Infinityedical Information Bus (Mib/mib II and Mib Duo) Protocol Converter	Draeger Medical Systems, Inc.	DRQ	Class II	2004-03-09
K033496	Midas Touch Blue Latex Examination Gloves - Powder Free for Chemotherapy Use	Industrial Clothings, Ltd.	LYY	Class I	2004-03-09
K033258	Bonesave Bone Void Filler	Howmedica Osteonics Corp	MQV	Class II	2004-03-09
K033191	Sohniks	Sohniks Endoscopy, Inc.	FAJ	Class II	2004-03-09
K032560	Arrowhead Spinal System	Medtronic Sofamor Danek	NKB	Class II	2004-03-09
K032459	Profile 1320 Laser System	Sciton, Inc.	GEX	Class II	2004-03-09
K040508	Vitalab Magnesium Reagent	Clinical Data, Inc.	JGJ	Class I	2004-03-08
K040467	Vitalab Uric Acid Reagent	Clinical Data, Inc.	KNK	Class I	2004-03-08
K040341	Clearblue Easy Earliest Results Pregnancy Test	Unipath, Ltd.	LCX	Class II	2004-03-08
K040329	Modification to E.p.t. Pregnancy Test	Unipath, Ltd.	LCX	Class II	2004-03-08
K040325	Panoret, Model Pnm 60	Medibell Medical Vision Technologies, Ltd.	HKI	Class II	2004-03-08
K040160	Quanta Plex Sle Profile 8	Inova Diagnostics, Inc.	LLL	Class II	2004-03-08
K040092	Ameditech Immu Test Drug Screen Panel	Ameditech, Inc.	DKZ	Class II	2004-03-08
K034067	Zti Implants System, Drm Implants	Drm Research Laboratories, Inc.	DZE	Class II	2004-03-08
K032091	Smart Klamp Various by Size	Emergogroup, Inc.	HFX	Class II	2004-03-08
K040455	Linical Uric Acid Calibration Verifiers Levels a - E for Olympus Au Systems	Cliniqa Corporation	JJX	Class I	2004-03-05
K040446	Angiodynamics, Inc. Morpheus Picc and Procedure Kit	Boston Scientific Corporation	LJS	Class II	2004-03-05
K040436	Simidur Superior	Wieland Dental + Technik GmbH & Co. KG	EJS	Class II	2004-03-05
K040405	Cem-Ostetic Putty Injection Kit, Model Pik-Xx, Pik-Xx-Yy	Berkeley Advanced Biomaterials	MQV	Class II	2004-03-05
K040288	Qsc-127-Int Shoulder Array Coil Set	Mri Devices Corp.	MOS	Class II	2004-03-05
K040260	Integral Hemodialysis Catheter	Arrow Intl., Inc.	MSD	Class II	2004-03-05
K040198	Labone Cocaine Metabolite Micro-Plate Eia	Labone, Inc.	DIO	Class II	2004-03-05
K040095	Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/igg Elisa	Immco Diagnostics, Inc.	MVM	Class II	2004-03-05
K034029	Ti Clip Applier	Gyrx, LLC	NJC	Class II	2004-03-05