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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 654 of 3529

510(k) clearances, page 654 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152084	Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug	Corentec Co., Ltd.	LPH	Class II	2016-04-29
K160128	Endopath Electrosurgery Probe Plus II	Ethicon Endo-Surgery Inc	GEI	Class II	2016-04-28
K152927	Brilliant Everglow	Coltene /Whaledent AG	EBF	Class II	2016-04-28
K152086	3Shape Ortho System	3Shape A/S	PNN	Class II	2016-04-28
K151502	Architect Roma	Fujirebio Diagnostics, Inc.	ONX	Class II	2016-04-28
K151086	ManoScan System	Given Imaging Ltd.	FFX	Class II	2016-04-28
K150598	Blockade Surgical Gown	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	2016-04-28
K160252	OmniPod Insulin Management System	Insulet Corporation	LZG	Class II	2016-04-27
K160236	Dual Pump Pack	Advanced Medical Optics, Inc.	HQC	Class II	2016-04-27
K160211	Wet Original Personal Lubricant	Trigg Laboratories D/B/A Wet International	NUC	Class II	2016-04-27
K160202	Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)	Siemens Healthcare Diagnostics Inc.	LEH	Class II	2016-04-27
K153526	Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2016-04-27
K153152	Syzygy Stabilization System	Spinal Elements, Inc	NKB	Class II	2016-04-27
K152724	Eyeprintpro (Roflufocon D) Scleral Gp Lenses	Advanced Vision Technologies	HQD	Class II	2016-04-27
K152227	Elecsys Cortisol II, Cortisol II CalSet	Roche Diagnostics GmbH	JFT	Class II	2016-04-27
K160858	CompactCath Intermittent Urinary Catheter	Compactcath, Inc	EZD	Class II	2016-04-26
K160756	PASS OCT Spinal System	Medicrea International	NKG	Class II	2016-04-26
K160522	White Pearl Preferred Angle Anterior Cervical Plate	Osseus Fusion Systems LLC	KWQ	Class II	2016-04-26
K160194	StarFuse Interphalangeal Pin	Phalanx Innovations	HTY	Class II	2016-04-26
K160176	Signia Stapler	Medtronic, Inc.	GDW	Class II	2016-04-26
K160162	Voluson P6, Voluson P8	GE Healthcare	IYN	Class II	2016-04-26
K153602	Materialise Glenoid Positioning System	Materialise N.V.	KWS	Class II	2016-04-26
K153453	Inertia Pedicle Screw and Deformity Correxxion System	Nexxt Spine LLC	NKB	Class II	2016-04-26
K153449	2008K2 Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2016-04-26
K153123	Genesys Spine Apache Interbody Fusion System	Genesys Spine	MAX	Class II	2016-04-26
K153050	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	Co-Innovation Biotech Co.,Ltd.	DJG	Class II	2016-04-26
K152727	ISEN-Goggles	Isen Tech.&trading Co., Ltd.	GWN	Class II	2016-04-26
K160285	Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202	Capillus, LLC	OAP	Class II	2016-04-25
K153407	Stryker Neptune 3 Waste Management System	Stryker Corp.	JCX	Class II	2016-04-25
K152934	MMS PTA Balloon Catheter	Micro Medical Solutions Inc	LIT	Class II	2016-04-25
K152493	POGO Automatic Blood Glucose Monitoring System	Intuity Medical, Inc.	NBW	Class II	2016-04-25
K151913	MIM-Thin Client (mobile)	MIM Software Inc	LLZ	Class II	2016-04-25
K151588	maxFit II Dental Implant System	Taiwan Implant Technology Company, Ltd.	DZE	Class II	2016-04-25
DEN150030	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay	Kronus, Inc.	PNI	Class II	2016-04-25
K160914	sterEOS Workstation	EOS imaging	LLZ	Class II	2016-04-22
K160814	Sydney IVF Sperm Cryopreservation Buffer	William A. Cook Australia Pty, Ltd.	MQL	Class II	2016-04-22
K160689	Reveal LINQ	Medtronic, Inc.	MXD	Class II	2016-04-22
K160633	G3(TM) Active Plate(R) Small Fragment System	Genesis Fracture Care, Inc.	HRS	Class II	2016-04-22
K160432	Anzai Respiratory Gating System	Anzai Medical Co, Ltd.	LHN	Class II	2016-04-22
K160353	Mx50n(mx50yqs)	Wide Corporation	PGY	Class II	2016-04-22
K160300	MotoBand(TM) CP Implant System	Crossroads Extremity Systems LLC	HRS	Class II	2016-04-22
K160227	ACCENTO / HWA Dual/Single laser	Bison Medical Co., Ltd	GEX	Class II	2016-04-22
K160216	Revolution Spinal Fixation System	Intelligent Implant Systems, LLC	NKB	Class II	2016-04-22
K160177	Gridlock Ankle Plating System	Trilliant Surgical LLC	HRS	Class II	2016-04-22
K160125	Cascadia Interbody System	K2M, Inc	ODP	Class II	2016-04-22
K160019	U80 Series Upper Arm Electronic Blood Pressure Monitor	Shenzhen Urion Technology Co., Ltd.	DXN	Class II	2016-04-22
K153737	OSTEOPAL plus	Heraeus Medical GmbH	LOD	Class II	2016-04-22
K153590	AvaDent Denture Base Material	Global Dental Science	EBI	Class II	2016-04-22
K153413	PASS LP Spinal System	Medicrea International	NKB	Class II	2016-04-22
K152701	Matrix Mini ECG Monitor	Global Instrumentation Corp.	DSI	Class II	2016-04-22