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 1523 of 3531

510(k) clearances, page 1523 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020968	Livesure Hcg Urinary Pregnancy Test Strip and Test Card	Pan Probe Biotech, Inc.	JHI	Class II	2002-07-15
K013713	Arm Automatic Reprocessing Machine	Alcavis International Incorporated	LIF	Class II	2002-07-15
K012543	Vision Sciences Endosheath System	Cogentix Medical, Inc.	EOB	Class II	2002-07-15
K021582	Bactec Mgit 960 Pza Kit	Becton Dickinson & Co	MJA	Class II	2002-07-13
K021311	Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material	Cp Medical	KXK	Class II	2002-07-13
K021202	Ultraquiet	Sound Technique System, LLC	KLW	Class II	2002-07-13
K021151	Ammonia Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	JIF	Class I	2002-07-13
K020585	Zip Open Forceps with Electrosurgical Cut	Gyrus ACMI, Inc.	GEI	Class II	2002-07-13
K022109	Eizo, Model Fc-2091	Eizo Nanao Corporation	LLZ	Class II	2002-07-12
K022053	Hydragel 7 Lipoprotein(e), Pn 4114 & Hydragel Lipoprotein(e) 15/30 Pn 4134	Sebia	JHO	Class I	2002-07-12
K022001	Mpower, Model 712 Series	Positron	KPS	Class II	2002-07-12
K021998	Horizons Cytology Brush	Horizons Intl. Corp.	FDX	Class II	2002-07-12
K021970	The Trabecular Metal Monoblock Cup, Models 00-7259-0Xx-28 (Zimmer Cat. #) and 02-293-28Xx1 (Implex Part #)	Implex Corp.	LPH	Class II	2002-07-12
K021927	Platelet Concentrate Separation Kit for Celsep Centrifuge System	Zimmer GmbH	LXG	Class I	2002-07-12
K021874	Abbott Q2 Plus S02/continuous Cardiac Output Computer, List Number 56711	Abbott Medical	DXG	Class II	2002-07-12
K021697	Glucose Control Solution for Bd Latitude	Bionostics, Inc.	JJX	Class I	2002-07-12
K021678	Hemaderm Cotaining Hemadex Clotting Beads	Medafor, Inc.	QSY	Unclassified	2002-07-12
K021676	Cypress Medical Products, Lp Disposable Vaginal Speculum, Non-Metal	Cypress Medical Products LLC	HIB	Class II	2002-07-12
K021624	RNA Gl4 Glucose Calibration Verification Control, Model RNA Cvc Gl4	Bionostics, Inc.	JJX	Class I	2002-07-12
K021611	Qab2a Igg Elisa Kit Hrp	Cheshire Diagnostics, Ltd.	MSV	Class II	2002-07-12
K021610	Qab2a Igm Elisa Kit Hrp	Cheshire Diagnostics, Ltd.	MSV	Class II	2002-07-12
K021581	Hemosorb	On Site Gas Systems Inc.	QSY	Unclassified	2002-07-12
K021525	Topcut	H.S. Hospital Service S.p.A.	FCG	Class II	2002-07-12
K021385	Atac Pak Bun Reagent	Elan Diagnostics	CDQ	Class II	2002-07-12
K021224	Endocervical Block Needle	CooperSurgical, Inc.	HEE	Class II	2002-07-12
K021199	Primechair	Dalton Medical Corp.	ITI	Class II	2002-07-12
K021191	Autoalign	Cortechs Labs, Inc.	LLZ	Class II	2002-07-12
K021185	Nervus Monitor	Taugagreining HF	OLV	Class II	2002-07-12
K021075	Mechanical Daily Use Wheelchair	First World Services, Inc.	IOR	Class I	2002-07-12
K020926	Extension Set, Models 1911-512	Epimed International, Inc.	FPA	Class II	2002-07-12
K020735	Sof-Pach Reusable Neurostimulation Electrodes	Cathay International, Ltd.	GXY	Class II	2002-07-12
K020704	Roche Online Gentamicin	Roche Diagnostics GmbH	LCD	Class II	2002-07-12
K020114	3D Knee	Encore Orthopedics, Inc.	JWH	Class II	2002-07-12
K020073	Medical Administrator	Barco N.V.	LLZ	Class II	2002-07-12
K020017	Medx 1000 Series	Medx Electronics, Inc.	ILY	Class II	2002-07-12
K022087	Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color	Shanghai PT Plastics Enterprise Company, Ltd.	LYZ	Class I	2002-07-11
K021959	Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100	Dolphin Medical, Inc.	DQA	Class II	2002-07-11
K021882	Crpex-Hs Crp Calibrator Set, Catalog No: 1510	Good Biotech Corp.	DCN	Class II	2002-07-11
K021817	Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical Generator, 240V	Apyx Medical Corporation	GEI	Class II	2002-07-11
K021616	Delight Dental Er: Yag Laser System	Continuum Electro-Optics, Inc.	GEX	Class II	2002-07-11
K021335	Monarch Spine System	Depuyacromed	MNH	Class II	2002-07-11
K021243	Ilt Torquer, Model 114Tr1	Intra Luminal Therapeutics, Inc.	DQX	Class II	2002-07-11
K020921	No-Pokes Needle Safety Device	Bemis Mfg. Co.	FMI	Class II	2002-07-11
K020794	Salicylate Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	DKJ	Class II	2002-07-11
K020792	Acetaminophen Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	LDP	Class II	2002-07-11
K020433	Ft101 Forehead Thermometer; Ft101 Infrared Digital Thermometer	Idt Technology Limited	FLL	Class II	2002-07-11
K014020	Nt Meditens Plus, Type 290	Bio-Medical Research, Ltd.	GZJ	Class II	2002-07-11
K014019	Neurotech Medistim Plus, Type 291	Bio-Medical Research, Ltd.	IPF	Class II	2002-07-11
K013892	Lutz Needle	Ballard Medical Products	BSP	Class II	2002-07-11
K013873	Cobra Cardiac Electrosurgical System	Boston Scientific Corporation	GEI	Class II	2002-07-11