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 2026-10-26, 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 737 of 3530

510(k) clearances, page 737 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142235	CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter	Abbott Medical	DQY	Class II	2014-12-18
K142049	Multix Fusion Va30 & Va40	Siemens Medical Solutions USA, Inc.	KPR	Class II	2014-12-18
K142043	Insync Zr High Translucency Zirconia	Jensen Industries, Inc.	EIH	Class II	2014-12-18
K141893	Vibrance Kegel Device (Vkd)	Bioinfinity (M) Sdn. Bhd.	HIR	Class II	2014-12-18
K141764	Tristar Bone Graft Fixation System	Impladent, Ltd.	JEY	Class II	2014-12-18
K141727	Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. Cad Series)	Liaoning Upcera Co.,Ltd	EIH	Class II	2014-12-18
K141712	Kimguard One Step Sterilization Wrap	Halyard Health	FRG	Class II	2014-12-18
K141530	Vdrive System/ Vdrive Duo/ Vdrive with V-Cas	Stereotaxis Inc	DXX	Class II	2014-12-18
K141474	Becton Dickinson Intelliport System	Becton Dickinson & Co	PHC	Class II	2014-12-18
K141420	Fastforward	Medshape, Inc.	HTN	Class II	2014-12-18
K141218	Zigiwire Mode2 Guidewire Wire System, Zigiwire Mode3 Guidewire Wire System	Vadiswire Corporation	DQX	Class II	2014-12-18
K141214	Aquapak Nebulizer Adaptors/reservoirs	Teleflexmedical, Inc.	CAF	Class II	2014-12-18
K140978	Osteomed Low Profile Orbital Floor Plate System	Osteomed	JEY	Class II	2014-12-18
K140855	Arthrex Suturetak Suture Anchors	Arthrex GmbH	MAI	Class II	2014-12-18
K140228	Disposable Tracheal Tube	Suzhou Weikang Medical Apparatus Co., Ltd.	BTR	Class II	2014-12-18
K140207	Rapid-I Kit	Vitrolife Sweden AB	MQK	Class II	2014-12-18
K133047	Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral Fluid Controls, Rapidease Oral Flu	Biophor Diagnostics, Inc.	LAF	Class II	2014-12-18
DEN140009	Amigo Remote Catheter System	Catheter Robotics, Inc.	PJB	Class II	2014-12-18
DEN130004	Moerae Surgical Marking Pen	Moerae Matrix, Inc.	PDW	Class II	2014-12-18
K143488	InFill Graft Delivery System	Pinnacle Spine Group, LLC	FMF	Class II	2014-12-17
K142997	RTHawk, HeartVista Workstation with RTHawk	Heartvista, Inc.	LNH	Class II	2014-12-17
K142891	Hepatiq	Hepatiq, LLC	LLZ	Class II	2014-12-17
K142721	cobas MRSA/SA Test	Roche Molecular Systems Inc	NQX	Class II	2014-12-17
K142718	Radlink GPS	Radlink, Inc.	MQB	Class II	2014-12-17
K142571	Powder Free Vinyl Patient Examination Gloves	Ever Light Plastic Products Co., Ltd.	LYZ	Class I	2014-12-17
K142492	Gm60a-32S, Gm60a-40S	Samsung Electronics Co., Ltd.	IZL	Class II	2014-12-17
K142377	The OnControl Bone Marrow Biopsy System by Vidacare	Teleflex Medical	KNW	Class II	2014-12-17
K142164	Manipulator; Manipulator Pro	Gynetech Pty., Ltd.	LKF	Class II	2014-12-17
K142089	Accu-Chek Aviva Expert System	Roche Diagnostics GmbH	LFR	Class II	2014-12-17
K142051	Prelude Plastic Jacketed Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2014-12-17
K141698	Sterizone Chemical Indicator	Tso3, Inc.	JOJ	Class II	2014-12-17
K141691	Gen_3	Free Wheelchair Mission	IOR	Class I	2014-12-17
K141580	Sterizone Self-Contained Biological Indicator	Tso3, Inc.	FRC	Class II	2014-12-17
K141366	Video Bronchoscope System	Schoelly Fiberoptic, GmbH	EOQ	Class II	2014-12-17
K141163	Sterizone Sterilizer	Tso3, Inc.	PJJ	Class II	2014-12-17
K140848	Luminesse Porcelain System	Talladium Inc	EIH	Class II	2014-12-17
K140793	Nanostim Introducer Kit	Abbott Medical	DYB	Class II	2014-12-17
K140592	Ceragem Automatic Thermal Massager	Ceragem International, Inc.	JFB	Class II	2014-12-17
K140536	Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T Guidewire	Lake Region Medical	DQX	Class II	2014-12-17
K140284	Given Pillcam Ugi Capsule Endoscopy System	Given Imaging Ltd.	NEZ	Class II	2014-12-17
K131643	Durex Realfeel Pleasure Gel Personal Lubricant	Reckitt Benckiser LLC	NUC	Class II	2014-12-17
K143296	AIA-PACK C-Peptide Control Set	Tosoh Bioscience Inc	JJX	Class I	2014-12-16
K143284	Elecsys Estradiol III Calcheck	Roche Diagnostics GmbH	JJX	Class I	2014-12-16
K143052	Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens	Yung Sheng Optical Co., Ltd.	LPL	Class II	2014-12-16
K142944	ArthroPlan Digital Templating Software	Arthromeda, Inc.	LLZ	Class II	2014-12-16
K142919	Exa	Viztek, LLC	LLZ	Class II	2014-12-16
K142789	A1c iGear System	Sakae Corporation	LCP	Class II	2014-12-16
K142772	Phlebo Press DVT 603	MEGO AFEK AC Ltd.	JOW	Class II	2014-12-16
K142715	Sensor Medical Family of Vitrectomy Lenses and Products	Sensor Medical Technology, LLC	HJK	Class II	2014-12-16
K142639	StitchKit	ORIGAMI SURGICAL Inc.	GAW	Class II	2014-12-16