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 2213 of 3531

510(k) clearances, page 2213 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940155	Enline Endoscopic Surgical Instruments	Surgigus Instruments, Inc.	GCJ	Class II	1994-03-30
K936120	Labor and Delivery Tray	Cush Medical Products	MLS	Class II	1994-03-30
K935671	2D, 3D Tof Mr Angiography	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-03-30
K935670	Version 3 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-03-30
K935621	Custom ENT Packs	Associated Medical	LRP	Class I	1994-03-30
K935548	Cathejell S Sterile Lubricating Jelly	Pharmazeutische Fabrik Montavit GmbH	FHX	Class II	1994-03-30
K934539	The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability	Intl. Remote Imaging Systems	GKL	Class II	1994-03-30
K933662	Merits Wheelchair	Merits Health Products, Inc.	ITI	Class II	1994-03-30
K933228	Kapton Peel Pouch	American Fluoroseal Corp.	KJA	Class I	1994-03-30
K932060	Martin Cold Light Fountain	Medline	GCJ	Class II	1994-03-30
K931979	Ventana Negative Control Reagent	Ventana Medical Systems Inc	DEM	Class II	1994-03-30
K931966	Dantec Disposable Concentric Needle	Dantec Medical, Inc.	IKT	Class II	1994-03-30
K931922	Diadot(tm) Virus/chlamydia Transport	Viratest Intl., Inc.	JSM	Class I	1994-03-30
K931118	Assess(tm) High Abnormal Control	Instrumentation Laboratory Co.	GJS	Class II	1994-03-30
K931117	Assess(tm) Low Abnormal Control	Instrumentation Laboratory Co.	GJS	Class II	1994-03-30
K926515	Card Guard Model Cg-8000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1994-03-30
K925907	Aquassager Wm110/w210 & Wm120 Body Basics Massager	Pollenex Corp.	ISA	Class I	1994-03-30
K925654	Cd Home Dialyservice Hemodialysis Tray	Cd Medical, Inc.	KOC	Class II	1994-03-30
K925122	Pace Saver Little Jr	Burke Mobility Products	INI	Class II	1994-03-30
K922247	Kinamed Reality Total Hip System	Kinamed Inc	LZO	Class II	1994-03-30
K922005	Granulyte Dialysate Concentrate	Fresenius USA, Inc.	KPO	Class II	1994-03-30
K921686	Endomed Laparoscopy Instruments	Buckman Co., Inc.	KNF	Class II	1994-03-30
K940856	Aurium G13 (High Gold Crown and Bridge Alloy)	Argen Precious Metals, Inc.	EJT	Class II	1994-03-29
K940789	Aurium C	Argen Precious Metals, Inc.	EJT	Class II	1994-03-29
K940587	Flex-I-Port	Access Surgical Intl., Inc.	GCJ	Class II	1994-03-29
K940300	Magellan	GE Healthcare	KPS	Class II	1994-03-29
K940063	Medtronic Interventional Vascular Y-Adapter, Tri-Adapter, Tri-Adapter & Accessory Packs	Medtronics Interventional Vascular	LIT	Class II	1994-03-29
K935752	Cp Flexible Coils/ Lp Circular Flex Coils	Siemens Medical Solutions USA, Inc.	LNH	Class II	1994-03-29
K935627	Cp Body Array/ Cp Spine Array Coil	Siemens Medical Solutions USA, Inc.	LNH	Class II	1994-03-29
K935566	Sensi-Cal Amco Aepa-1	Radiometer America, Inc	LIE	Class II	1994-03-29
K934543	Universal Controller, Model 100	Metamed, Inc.	LDR	Class II	1994-03-29
K934232	Commuter (Manual/power Wheelclhair)	Fortress Lite-Style Wheelchairs, Inc.	ITI	Class II	1994-03-29
K933926	Llcmk2 Culture Cells	Neogenex	KIR	Class I	1994-03-29
K933925	Mrc-5 Culture Cell	Neogenex	KIR	Class I	1994-03-29
K933924	Mccoy Culture Cell	Neogenex	KIR	Class I	1994-03-29
K933923	A549 Culture Cell	Neogenex	KIR	Class I	1994-03-29
K933550	Hydraspun M Sterilization Wrap	Ahlstrom Dexter	FRG	Class II	1994-03-29
K932738	Kappler Pro/vent Boot	Kappler, Inc.	FXP	Class I	1994-03-29
K932701	Cedars-Sinai Quantitive Thallium 201 Analysis	Nuccardiac Software, Inc.	IYX	Class I	1994-03-29
K932694	Kappler Pro/vent Procedure Gown	Kappler, Inc.	FYA	Class II	1994-03-29
K931929	Techmedica Continuum Hip System	Techmedica, Inc.	LZO	Class II	1994-03-29
K931109	Nucleotome E Kit	Surgical Dynamics Ltd	HRX	Class II	1994-03-29
K930972	Intramedullary Systems	Baumer Ortopedia, Ltd.	HSB	Class II	1994-03-29
K930969	Baumer Pins	Baumer Ortopedia, Ltd.	HTY	Class II	1994-03-29
K930297	Fujinon Video Laparoscope, Modified	FUJIFILM Healthcare Americas Corporation	FWF	Class I	1994-03-29
K925724	M100 Powered Wheelchair	Mcnally Industries, Inc.	ITI	Class II	1994-03-29
K924527	Vivus 5000 Infusion System	Halyard Health	FRN	Class II	1994-03-29
K924434	Cidex Activated Dialdehyde Solution	Johnson & Johnson MEDICAL GmbH	LRJ	Class I	1994-03-29
K924334	Cidex Formula 7* Long-Life Activated Dialdehyde	Johnson & Johnson MEDICAL GmbH	MED	Class II	1994-03-29
K923744	Cidex Plus 28 Day Solution	Johnson & Johnson MEDICAL GmbH	LRJ	Class I	1994-03-29