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 619 of 3529

510(k) clearances, page 619 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162351	SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device	SeaSpine Orthopedics Corporation	OVD	Class II	2016-12-01
K162176	Fiagon Navigation System	Fiagon GmbH	PGW	Class II	2016-12-01
K162140	RemLogic	Embla Systems	OLZ	Class II	2016-12-01
K161906	SCIg60 Infuser	Emed Technologies Corporation	PKP	Class II	2016-12-01
K161704	Phasor Drill	Biotex, Inc.	HBE	Class II	2016-12-01
K161548	Osseointegrated Fixtures	Southern Implants, (Pty.) Ltd.	FZE	Class II	2016-12-01
K161470	Internal Distraction - Sterile	KLS-Martin L.P.	MQN	Class II	2016-12-01
K161128	Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply	Medela AG	OMP	Class II	2016-12-01
K160157	LOSPA Modular Knee System	Corentec Co., Ltd.	JWH	Class II	2016-12-01
K152420	AK Body Toning Device	Ak Beauty Enterprises, LLC	NGX	Class II	2016-12-01
K152327	EasyLyte Na/K/Cl/Ca Analyzer	Medica Corp.	JFP	Class II	2016-12-01
K150960	WoundPro Negative Pressure Wound Therapy System	Pensar Medical	OMP	Class II	2016-12-01
K163139	PleuraFlow System with FlowGlide	Clearflow, Inc	OTK	Class II	2016-11-30
K163138	Clarius Ultrasound System	Clarius Mobile Health Corp	IYN	Class II	2016-11-30
K163102	ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm	Medtronic, Inc.	GCJ	Class II	2016-11-30
K163092	TubeClear Control Box and Clearing Stem	Actuated Medical, Inc.	KNT	Class II	2016-11-30
K163043	Zeramex P6 Dental Implant System	Dentalpoint AG	DZE	Class II	2016-11-30
K162966	TxRx Knee 15 Flare MR Coil 1.5T	Quality Electrodynamics	MOS	Class II	2016-11-30
K162450	ESPADA Acne-Clearing Blue Light Pen	Foreo Inc	OLP	Class II	2016-11-30
K162214	Protek Solo 24 Fr Venous Cannula Set	Cardiacassist, Inc.	DWF	Class II	2016-11-30
K161834	One Drop Blood Glucose Monitoring System	Agamatrix	NBW	Class II	2016-11-30
K161431	SimplECG	Nanowear, Inc.	DXH	Class II	2016-11-30
K161391	DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives	Alcon Laboratories	LPL	Class II	2016-11-30
K161323	Solution Set for Epidural Use	Baxter Healthcare Corporation	FPA	Class II	2016-11-30
K153317	HEMASORBPLUS Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2016-11-30
K163066	TxRx Knee 15 Flare MR Coil 3.0T	Quality Electrodynamics	MOS	Class II	2016-11-29
K162466	LuminScan (TM) Imaging System	Micro-Tech (Nanjing) Co., Ltd.	NQQ	Class II	2016-11-29
K162414	UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2016-11-29
K161776	Lenstec LC Injection system	Lenstec, Inc.	MSS	Class I	2016-11-29
K161013	InnoSEAL Hemostatic Pad	Innotherapy, Inc.	QSY	Unclassified	2016-11-29
K160801	Well Lead Extraction Bag	Well Lead Medical Co. Ltd	GCJ	Class II	2016-11-29
K160642	Medline ENFit Syringe	MEDLINE INDUSTRIES, LP - Northfield	PIF	Class II	2016-11-29
K163207	Filtek One Bulk Fill Restorative	3M Company	EBF	Class II	2016-11-28
K162451	Solana HSV 1+2/VZV Assay	Ortho-Clinical Diagnostics, Inc.	PGI	Class II	2016-11-28
K162211	AccuFit Lateral Plate System	Precision Spine, Inc.	KWQ	Class II	2016-11-28
K161962	VAMP Venous/Arterial Blood Management Protection System	Edwards Lifesciences LLC	KRA	Class II	2016-11-28
K161932	Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink	Terang Nusa (Malaysia) Sdn. Bhd.	LZA	Class I	2016-11-28
K160720	Carriere Motion Clear Class II	Ortho Organizers Inc	DYW	Class II	2016-11-28
K160530	Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff	Shenzhen Med-Link Electronics Tech Co.,Ltd	DXQ	Class II	2016-11-28
K162183	Vantage Galan 3T, MRT-3020, V4.0	Toshibamedical Systems Corporation	LNH	Class II	2016-11-25
K161819	NNR06 Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	2016-11-25
K163007	Biomet Microfixation SternaLock 360 Sternal Closure System	Biomet Microfixation	HRS	Class II	2016-11-23
K162462	AMICUS Separator System, AMICUS Separator System; Refurbished	Fresenius Kabi USA, LLC	GKT	Class II	2016-11-23
K162444	Xpert MRSA NxG	Cepheid	NQX	Class II	2016-11-23
K162396	SILK Surgical Suture	Teleflexmedical, Inc.	GAP	Class II	2016-11-23
K162148	Allura Xper R9	Philips Medical Systems Nethrlands BV	OWB	Class II	2016-11-23
K162103	Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)	Choicespine, LP	MAX	Class II	2016-11-23
K161957	W&H Implantmed SI-1015 incl. Accessories	W&H Dentalwerk Burmoos GmbH	EBW	Class I	2016-11-23
K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)	Stryker Corp.	KWS	Class II	2016-11-23
K161696	aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5	AAP Implantate AG	HRS	Class II	2016-11-23