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 719 of 3530

510(k) clearances, page 719 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142740	Ziehm Vision RFD 3D	Ziehm Imaging GmbH	OWB	Class II	2015-04-06
K141913	Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse Me!	pjur group Luxembourg S.A.	NUC	Class II	2015-04-06
K141619	Luofucon Silver Foam Dressing	HuiZhou Foryou Medical Devices Co., Ltd.	FRO	Unclassified	2015-04-06
K140233	Ultrasonic Scaler	Nanning Baolai Medical Instrument Co., Ltd	ELC	Class II	2015-04-06
K150507	Santis Pedicle Screw System	Lanterna Medical Technologies	NKB	Class II	2015-04-03
K150343	V8 Transluminal BAV Catheter	Intervalve, Inc.	OZT	Class II	2015-04-03
K150262	Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular	Volcano Corporation	DTK	Class II	2015-04-03
K150206	InFill Interbody Fusion Devices	Pinnacle Spine Group, LLC	MAX	Class II	2015-04-03
K150164	Monobond Etch & Prime	Ivoclar Vivadent, Inc.	KLE	Class II	2015-04-03
K150106	2MP Color LCD Monitor, RadiForce RS240	Eizo Corporation	PGY	Class II	2015-04-03
K150027	Cyma	Whitecap Technologies, LLC	GEX	Class II	2015-04-03
K143749	Arthrex Distal Radius System	Arthrex GmbH	HRS	Class II	2015-04-03
K143733	Digital Automatic Wrist Blood Pressure Monitor MD2400	Grandway Technology (Shenzhen) Limited	DXN	Class II	2015-04-03
K143654	Valleylab LS10 Generator	Medtronic, Inc.	GEI	Class II	2015-04-03
K143575	Accu-Dent XD Tray, Accu-Dent XD Syringe	Ivoclar Vivadent, Inc.	ELW	Class II	2015-04-03
K143475	VAPR Tripolar Suction Electrode	DePuy Mitek, Inc.	GEI	Class II	2015-04-03
K143360	LnK Cervical Interbody Fusion Cage System	L&K Biomed Co.,Ltd.	ODP	Class II	2015-04-03
K143053	KIMGUARD ONE-STEP Sterilization Wrap	Kimberly-Clark Health Care	FRG	Class II	2015-04-03
K142761	Corin TaperFit Hip Stem	Corin USA	JDI	Class II	2015-04-03
K142569	Aptis Medical Distal Radio Ulnar Joint Implant	Aptis Medical, LLC.	KXE	Class II	2015-04-03
K142454	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	Advanced Sterilization Products	MLR	Class II	2015-04-03
K141683	Electronic Blood Pressure Monitor	Shenzhen Urion Technology Co., Ltd.	DXN	Class II	2015-04-03
K150747	EzDent-i /E2/Prora View	LK Consulting Group USA, Inc.	LLZ	Class II	2015-04-02
K150545	Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)	Sejoy Electronics & Instruments Co., Ltd.	DXN	Class II	2015-04-02
K150510	Total Bilirubin	Abbott Medical	CIG	Class II	2015-04-02
K150438	Force Fiber OrthoTape suture	Teleflexmedical, Inc.	GAT	Class II	2015-04-02
K150413	QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator	Cymedica Orthopedics, Inc.	IPF	Class II	2015-04-02
K150227	Disposable Blood Pressure Cuff Guard	Pinhu Sama Medical Packing Co., Ltd.	DXQ	Class II	2015-04-02
K150165	Gc85a	Samsung Electronics Co., Ltd.	KPR	Class II	2015-04-02
K150060	J2A Dental Implant System, J2C Dental Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2015-04-02
K150010	Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port	Cedic S.r.l.	PIO	Class II	2015-04-02
K143480	Euphora Rapid Exchange Balloon Dilatation Catheter	Medtronic, Inc.	LOX	Class II	2015-04-02
K143372	Aware	Ambient Clinical Analytics	MWI	Class II	2015-04-02
K143353	Hahn Tapered Implant System	Prismatik Dentalcraft, Inc.	DZE	Class II	2015-04-02
K143132	IS4000 8mm Harmonic ACE Curved Shears	Intuitive Surgical, Inc.	NAY	Class II	2015-04-02
K143043	Tanning Lamp	Unilam Co., Ltd.	LEJ	Class II	2015-04-02
K143018	Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors	Medtronic, Inc.	PIF	Class II	2015-04-02
K142217	Reliance Interspinous Plate System	Reliance Medical Systems, LLC	PEK	Class II	2015-04-02
K142024	Brightmatter Navigation System	Synaptive Medical Inc	HAW	Class II	2015-04-02
K141934	Physica Kr Knee System	Lima Corporate S.p.A.	JWH	Class II	2015-04-02
K141826	Flashpak Sterilization Container System	Symmetry Medical, Inc. - Manchester	FRG	Class II	2015-04-02
K141812	Mygait Stimulation System	Otto Bock Healthcare Products GmbH	GZI	Class II	2015-04-02
K141687	Aesculap - Meithke Progav 2.0 Adjustable Shunt System	Aesculap Inc	JXG	Class II	2015-04-02
K141227	Polaris Pressure Adjustable Valve System/polaris Adjustable Valve with Siphonx	Sophysa	JXG	Class II	2015-04-02
K150631	St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter	Abbott Medical	DRF	Class II	2015-04-01
K150263	K-Pack II Needle-21G x 2	Terumo Europe N.V.	FMI	Class II	2015-04-01
K150253	Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm	Taiwan Surgical Corporation	GCJ	Class II	2015-04-01
K143459	Silk Road Acccess Catheter	Silk Road Medical	DQY	Class II	2015-04-01
K143338	Argulated Locking Plates	Osteomed	JEY	Class II	2015-04-01
K143336	Biomet Microfixation OmniMax MMF System	Biomet Microfixation	JEY	Class II	2015-04-01