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 2026-11-02, 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 1007 of 3531

510(k) clearances, page 1007 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101335	Cell-Chex	Streck LLC	GLQ	Class II	2010-08-23
K101068	Accufit Dental Implant Abutments & Screws	Radiant Express, LLC	NHA	Class II	2010-08-23
K093916	Neobase Non-Derivatized Msms Kit Model 3040-001U	Revvity Health Sciences, Inc.	NQL	Class II	2010-08-23
K093783	Innovia Innoport Laparoscopic Access Port	Innovia, LLC	GCJ	Class II	2010-08-23
K093510	Lumenvu Catheter Guidance System	FUJIFILM SonoSite,Inc.	OMF	Class II	2010-08-23
K093204	Innovative Med Multi Wave Light Therapy System	Innovative Med, Inc.	ILY	Class II	2010-08-23
K101717	Dental Handpieces, Models: Karam Std/mini; Breeze Std/mini: Karam 45; Dexor 45; Karam 4H Coupling	Aerobine, Inc.	EFB	Class I	2010-08-20
K101359	Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 Ml)	Inviro Medical Devices, Inc.	FMF	Class II	2010-08-20
K101342	Osirix Md	Pixmeo SARL	LLZ	Class II	2010-08-20
K101272	Mass Oxygen Distribution System (Mods) Model 10C-0061-3	Essex Industries, Inc	BYJ	Class II	2010-08-20
K100753	Flight 60 Ventilator, Model F-60	Flight Medical Innovations Ltd.	CBK	Class II	2010-08-20
K100512	Nobelprocera Ips E.max Crown	Nobel Biocare AB	EIH	Class II	2010-08-20
K093622	Aem Monitoring System, Models Em2, Emr, Es4007, Es4107, Es9005 and Es9015	Encision, Inc.	GEI	Class II	2010-08-20
K093269	Procedure Rehearsal Studio	Simbionix, Ltd.	LLZ	Class II	2010-08-20
K093043	Zirconia Syringe Needle	Kuo Tai Hospital Managements & Consultant Co., Ltd.	FMI	Class II	2010-08-20
K092767	Bbl Chromagar Mrsa II	Becton Dickinson & Co	JSO	Class II	2010-08-20
K101816	Stn Probe	Summit Doppler Systems, Inc.	ITX	Class II	2010-08-19
K101798	Spi Variomulti Angled Abutment	Thommen Medical AG	NHA	Class II	2010-08-19
K101789	Reprocessed Electrophysiology Diagnostic Catheters	Sterilmed Inc	NLH	Class II	2010-08-19
K101493	Advanced Glass Ionomer (K-130) Restorative	Dentsply International, Inc.	EMA	Class II	2010-08-19
K101329	Synergy CT Picc	Health Line International Corporation	LJS	Class II	2010-08-19
K101213	Grandio Flow	Voco GmbH	EBF	Class II	2010-08-19
K100912	Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side by Side	Kirwan Surgical Products, LLC	GXZ	Class II	2010-08-19
K100841	Boneoptimizer	Curasan AG	MQV	Class II	2010-08-19
K101709	Lambergsleepwell- Smartrusion (Lsw-S)	Steven B. Lamberg, Dds	LRK	Class II	2010-08-18
K101704	Zimmer Dto Pin Press Instrument	Zimmer Spine, Inc.	NQP	Class II	2010-08-18
K101152	Naturalase Diode Laser Family Naturalase Model Nl980, Naturalase Diode Laser Family Naturalase Nl810	Focus Medical, LLC.	GEX	Class II	2010-08-18
K093785	Modular Endoscope	Sialo Technology, Ltd.	GCJ	Class II	2010-08-18
K091424	Osta Maxigro and Regigro	Osta Technologies	NPM	Class II	2010-08-18
K091047	Neonate Array Coils	LMT Medical Systems GmbH	MOS	Class II	2010-08-18
K102167	Lo-50 LED Light Source	Fiberoptics Technology, Inc.	NTN	Class II	2010-08-17
K102148	Curiepacs (Dicom Pacs Software)	Moksha Digital Software Pvt Limited	LLZ	Class II	2010-08-17
K102012	Digital Radiography	Canon Inc. -Medical Equipment Group	MQB	Class II	2010-08-17
K101565	Powder - Free Patient Examination Gloves	Zibio Yingjie Medical Products Co., Ltd.	LYZ	Class I	2010-08-17
K101424	Pharmacaribe Inhaled Saline Solutions	Pharmacaribe LLC	CAF	Class II	2010-08-17
K101325	Stellaris Pc Vision Enhancement System	Bausch & Lomb Incorporated	HQC	Class II	2010-08-17
K101241	Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)	Lil Drug Store Products, Inc.	NUC	Class II	2010-08-17
K101098	Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035	Lil Drug Store Products, Inc.	NUC	Class II	2010-08-17
K101038	Rad II Simulator, Rad II Kv Imager, Dual Rad II Kv Imager	Acceletronics Digital Imaging, LLC	KPQ	Class II	2010-08-17
K100988	Humapen Luxura Hd	Eli Lilly and Company, Pharmaceutical Delivery Systems	FMF	Class II	2010-08-17
K100975	Nitril Exam Glove, Pre-Powered Color White, Nitrile Exam Glove, Pre-Powdered, Color Blue	Jiangsu Sunshine Plastic Products, Co., Ltd.	LZA	Class I	2010-08-17
K100843	Abreu, Model 700	Brain Tunnelgenix Technologies Corporation	FLL	Class II	2010-08-17
K100354	Primal Ok Interspinous Fusion System	Osteomed	KWP	Class II	2010-08-17
K100245	Hs/hg Prosthetic System	OSSTEM Implant Co., Ltd.	NHA	Class II	2010-08-17
K094043	Ligamentotaxor	Arex USA	HTY	Class II	2010-08-17
K101749	Syngo Trued Software	Siemens Medical Solutions	LLZ	Class II	2010-08-16
K101462	Ascend Blue Ac Mesh; Ascend Blue Pc Mesh	Caldera Medical, Inc.	FTL	Class II	2010-08-16
K101364	Lanx Facet Screw System	Lanx, Inc.	MRW	Unclassified	2010-08-16
K101029	Kaifeng/crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/royal Synthetic Polymer Teeth	Huge Dental Material Co., Ltd.	ELM	Class II	2010-08-16
K101004	Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment	Astra Tech, Inc.	NHA	Class II	2010-08-16