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 615 of 3529

510(k) clearances, page 615 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160588	Xn Check Bf	Streck LLC	JPK	Class II	2016-12-22
K160586	Xn-L Check	Streck LLC	JPK	Class II	2016-12-22
K160585	Xn Cal	Streck LLC	KRX	Class II	2016-12-22
K160538	Sysmex XN-L Automated Hematology Analyzer	Sysmex America, Inc.	GKZ	Class II	2016-12-22
K160309	Neurosoft TMS	Teleemg, LLC	OBP	Class II	2016-12-22
K151545	CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System	Polymer Technology Systems	CHH	Class I	2016-12-22
K163311	GMK Revision Femoral Distal Augmentation	Medacta International SA	KRO	Class II	2016-12-21
K163266	Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument	Alere Scarborough, Inc.	OCC	Class II	2016-12-21
K163264	Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled	Avinger, Inc.	MCW	Class II	2016-12-21
K163086	VLP MINI-MOD 2.0mm Column Plates	Smith & Nephew, Inc.	HRS	Class II	2016-12-21
K162717	Evolution Esophageal Stent System – Partially Covered	Cook Ireland Ltd.	ESW	Class II	2016-12-21
K162677	L- Ovc	Rhondium Limited	EIH	Class II	2016-12-21
K162555	Evs 4343, Evs 4343G	DRTECH Corporation	MQB	Class II	2016-12-21
K162436	EndoVac Pure	Sybron Dental Specialties, Inc.	NYL	Class I	2016-12-21
K162421	IntelliCartTM System	Dornoch Medical Systems	JCX	Class II	2016-12-21
K162259	DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)	Zibo Daiyang Plastic Company	LYZ	Class I	2016-12-21
K162251	Reprocessed Viking Diagnostic Electrophysiology Catheters	Innovative Health, LLC.	NLH	Class II	2016-12-21
K162128	Scope Buddy Plus Endoscope Flushing Aid	Medivators Inc	FEB	Class II	2016-12-21
K162003	IMSE Cervical Cage	Institute of Musculoskeletal Science & Education	ODP	Class II	2016-12-21
K161928	Capi 3 Immunotyping, Capillarys 3 Tera, It/if Control	Sebia, Inc.	CFF	Class II	2016-12-21
K161916	TelePatch Cardiac Monitor	Medicomp, Inc.	DRG	Class II	2016-12-21
K161723	ulrich Transfer Set	Ulrich GmbH & Co. KG	PQH	Class II	2016-12-21
K161716	Teethan 2.0	Bts S.p.A.	KZM	Class II	2016-12-21
K161566	DMS Disposable Subdermal Needle Electrodes	Daehan Medical Systems Co.,Ltd	GXZ	Class II	2016-12-21
K161307	NICO Myriad	Nico Corporation	GEI	Class II	2016-12-21
K161215	Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs	Brightway Holdings Sdn. Bhd.	LZA	Class I	2016-12-21
K161197	Orthodontic Screw	OSSTEM Implant Co., Ltd.	OAT	Class II	2016-12-21
K160942	Sonablate	Sonacare Medical, LLC	PLP	Class II	2016-12-21
K153426	Ox-Imager CS	Modulated Imaging, Inc.	MUD	Class II	2016-12-21
K152778	TRACOE Cuff Pressure Monitor	Tracoe Medical GmbH	BSK	Class II	2016-12-21
DEN160020	CipherOx CRI Tablet	Flashback Technologies, Inc.	PPW	Class II	2016-12-21
DEN150055	AeroForm Tissue Expander System	Airxpanders, Inc.	PQN	Class II	2016-12-21
K163301	CD HORIZON® Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2016-12-20
K162630	CP Relief Wand-OTC	Mid-America Medical Innovations, LLC	NUH	Class II	2016-12-20
K162461	Endoform Plastics and Reconstructive Matrix	Aroa Biosurgery (Formerly Mesynthes Limited)	FTM	Class II	2016-12-20
K162344	Innolux Ric	Innolux Corporation	MQB	Class II	2016-12-20
K160928	Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)	Hartalega Sdb. Bhd.	KGO	Class I	2016-12-20
K160879	CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems	Medos International SARL	PML	Class II	2016-12-20
K160574	K3pro Surgical Tray	Argon Med. Productions Vertriebs Gesellschaft mbH CO KG	KCT	Class II	2016-12-20
DEN150022	Ultravision Visual Clearing System	Alesi Surgical Ltd	PQM	Class II	2016-12-20
K162955	Multi-Modality Tumor Tracking (MMTT) application	Philips Medical Systems Nederland B.V.	LLZ	Class II	2016-12-19
K162854	Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml	Liofilchem S.r.l.	JWY	Class II	2016-12-19
K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	Becton Dickinson & Co	FMF	Class II	2016-12-19
K161871	EVA (Enhanced Visual Assessment) System	Mobileodt, Ltd.	HEX	Class II	2016-12-19
K161739	Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2016-12-19
K161390	Vinyl Exam Gloves, Powder Free, Clear	Zibo Hongchin Plastic and Rubber Co., Ltd.	LYZ	Class I	2016-12-19
K161259	KLS Martin Cannulated Headless Screws	KLS-Martin L.P.	HWC	Class II	2016-12-19
K160854	MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture	Biomet Manafacturing Corp.	GAT	Class II	2016-12-19
K160771	Destiknee Total Knee System	Meril Healthcare Private Limited	JWH	Class II	2016-12-19
K160571	cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay	Roche Diagnostics Operations (Rdo)	PDJ	Class II	2016-12-19