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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 894 of 3530

510(k) clearances, page 894 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111818	Sonixgps Needle Sensor	Ultrasonix Medical Corporation	IYO	Class II	2012-06-13
K121487	Litecure Therapy Compact	LiteCure, LLC	ILY	Class II	2012-06-12
K121328	Agility	Elekta Limited	IYE	Class II	2012-06-12
K121249	Multiarray Kit	Paramed S.r.l.	MOS	Class II	2012-06-12
K121145	Renu Medical Reprocessed Aircast Venaflow Calf Garments/all Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme	Renu Medical, Inc.	JOW	Class II	2012-06-12
K120833	Discovery Ct750 Hd	GE Healthcare	JAK	Class II	2012-06-12
K120772	Ncb Periprosthetic Trochanter Plates and Screws, Ncb Cable Button for Ncb Oplyaxial Locking Plate	Zimmer GmbH	HRS	Class II	2012-06-12
K120769	Modulth Slk	Karl Storz Endoscopy-America, Inc.	LNS	Class II	2012-06-12
K120695	Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit	Dentist in A Box Pty., Ltd.	EMB	Class I	2012-06-12
K120665	Invent Snoring Device	Ventus Medical, Inc.	LWF	Class I	2012-06-12
K120476	Macrolyte Dispersive Electrode	ConMed Corporation	GEI	Class II	2012-06-12
K120322	Conmed Surefit Dual Dispersive Electrode	ConMed Corporation	GEI	Class II	2012-06-12
K120098	Sterile Disposables for Mer	Alpha Omega Engineering Ltd.	GZL	Class II	2012-06-12
K120045	Emm High Performance Surgical Gown with AAMI Liquid Barrier Level IV	Exact Medical Manufacturing, Inc.	FYA	Class II	2012-06-12
K113658	Amplatzer Vascular Plug 4	Abbott Medical	KRD	Class II	2012-06-12
K113628	Amigo Remote Catheter System (Rcs) & Accessories	Catheter Robotics, Inc.	DXX	Class II	2012-06-12
K121240	Reprocessed Endoscopic Trocars	Sterilmed Inc	NLM	Class II	2012-06-11
K120494	Disposable Adhesive Surface Electrode	Spes Medica S.P.A	GXY	Class II	2012-06-11
K120352	Stryker Quikflap Sterile Procedure Pack	Stryker Corp.	GWO	Class II	2012-06-11
K120174	Deput Delta Xtend Reverse Shoulder	Depuy France	PHX	Class II	2012-06-11
K113868	Eplus Skin Treatment System	Syneron, Ltd.	GEX	Class II	2012-06-11
K113411	Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic Perfusion Cannula	Edwards Lifesciences LLC	DWF	Class II	2012-06-11
K113205	Artisyn Y-Shaped Mesh	Ethicon, Inc	OTO	Class II	2012-06-11
K113022	Puresleep	Sleep Science Partners, Inc.	LRK	Class II	2012-06-11
K112729	Blease700/900 Series Ventilators	GE Healthcare	CBK	Class II	2012-06-11
DEN080015	Nucleus-X Ptv Catheter	Numed Inc	OZT	Class II	2012-06-11
K121554	Q-Flo Closed Male Luer Connector	Us Fusion, LLC. dba Truecare Biomedix-USA	FPA	Class II	2012-06-08
K121545	Bellyboard, Sbrt Accessories	Medtec Inc. dba Civco Medical Solutions	LNH	Class II	2012-06-08
K121412	Pax-Flex3d, Pht-7000	Vatech Co., Ltd.	OAS	Class II	2012-06-08
K121402	Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G	Trireme Medical, Inc.	LIT	Class II	2012-06-08
K121074	Scenium 2.0	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2012-06-08
K121011	Amistem and Quadra - Line Extension	Medacta International SA	LZO	Class II	2012-06-08
K120846	Transport Culture Medium Device	Puritan Medical Products Company, LLC	LIO	Class I	2012-06-08
K120820	Giraffe Blue Spot Pt Lite	Lumitex Medical Devices, Inc.	LBI	Class II	2012-06-08
K120790	Gmk - Line Extension	Medacta International SA	JWH	Class II	2012-06-08
K120784	Tuff-Temp 2.0	Pulpdent Corporation	EBG	Class II	2012-06-08
K120752	Aerodr Stitching System	Konica Minolta Medical & Graphic, Inc.	KPR	Class II	2012-06-08
K120624	Elcam Disposable Integrated Pressure Transducer (Dipt)	Elcam Medical A.C.A.L.	DRS	Class II	2012-06-08
K120551	Simuplan Treatment Planning System	Simuplan S.L.	MUJ	Class II	2012-06-08
K120470	Mipal	WATERMARK MEDICAL Inc	DRG	Class II	2012-06-08
K120465	Earlysense (Everon) System	Earlysense, Ltd.	BZQ	Class II	2012-06-08
K120432	Telio Cs Cem Implant	Ivoclar Vivadent, Inc.	EMA	Class II	2012-06-08
K120334	Viva Eb	Etview, Ltd.	CBI	Class II	2012-06-08
K120214	Tbd	LENSAR, Inc	OOE	Class II	2012-06-08
K120164	Proteus Pta Balloon Catheter with Embolic Capture Feature	Angioslide, Ltd.	LIT	Class II	2012-06-08
K112860	Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	2012-06-08
K111718	Lano-E	UG Global Resources Sdn Bhd	LZA	Class I	2012-06-08
K111604	Lano-E	UG Global Resources Sdn Bhd	LYY	Class I	2012-06-08
K121444	Flat Panel Detector	Canon, Inc. - Medical Equpment Group	OWB	Class II	2012-06-07
K121381	Viewflex Xtra Ice Catheter	Abbott Medical	IYO	Class II	2012-06-07