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 552 of 3529

510(k) clearances, page 552 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171834	G Surgical OCT Spinal System	G Surgical Co., Ltd.	NKG	Class II	2017-12-19
K171552	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV	Cepheid	OCC	Class II	2017-12-19
K171012	Veraview X800	J. Morita USA, Inc.	OAS	Class II	2017-12-19
K170862	Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope	Solace Therapeutics	FAJ	Class II	2017-12-19
DEN170075	ContainOR	Advanced Surgical Concepts	PZQ	Class II	2017-12-19
DEN160062	IlluminOss Bone Stabilization System	Illminoss Medical, Inc.	QAD	Class II	2017-12-19
K173124	PEEK Biosolution	Merz Dental GmbH	EBF	Class II	2017-12-18
K172918	DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)	KaVo Dental Technologies, LLC	MUH	Class II	2017-12-18
K172286	Automated Blood Coagulation Analyzer CS-2500	Siemens Healthcare Diagnostic Products GmbH	JPA	Class II	2017-12-18
K171858	Sidus Stem-Free Shoulder	Zimmer GmbH	PKC	Class II	2017-12-18
K171193	Certa Catheter	Ferrosan Medical Devices Sp. Z.O.O.	BSO	Class II	2017-12-18
K171174	PERIO-FLOW nozzle	E.M.S. - Electro Medical Systems SA	EFB	Class I	2017-12-18
K171909	HAL for Medical Use (Lower Limb Type)	Cyberdyne Inc.	PHL	Class II	2017-12-17
K173687	Strange Bile Duct Stone Exploration Set	Cook Incorporated	LQR	Class II	2017-12-15
K173532	Raider Guidewire	Vascular Solutions LLC	DQX	Class II	2017-12-15
K173354	BD Nexiva Diffusics Closed IV Catheter Systems	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2017-12-15
K173017	Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)	Anhui Kindguard Medical Supplies Technology Co.,Ltd	LYZ	Class I	2017-12-15
K172888	EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages	Eit Emerging Implant Technologies GmbH	MAX	Class II	2017-12-15
K172844	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2017-12-15
K172594	Proficient® Posterior Cervical Spine System	Spine Wave Inc	NKG	Class II	2017-12-15
K172573	ReBOSSIS85	Orthorebirth Co Ltd	MQV	Class II	2017-12-15
K172494	PROTEUS PTA Balloon Catheter with Embolic Capture Feature	Angioslide, Ltd.	LIT	Class II	2017-12-15
K172482	The Nellcor pulse oximetry monitor interface cable	Medtronic, Inc.	DQA	Class II	2017-12-15
K172473	LifeStyles® SKYN® Intimate Moments Personal Lubricant	Sxwell USA LLC	NUC	Class II	2017-12-15
K172465	Idys™ TLIF 3DTi Cages	Clariance-SAS	MAX	Class II	2017-12-15
K172350	AxSOS 3 Ti	Stryker Corp.	HRS	Class II	2017-12-15
K172337	MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2017-12-15
K172311	BioFlux Device	Biotricity	DXH	Class II	2017-12-15
K172228	pioli IOL Delivery System	AST Products, Inc.	MSS	Class I	2017-12-15
K171611	Double Lumen Ovum Aspiration Needles	William A. Cook Australia Pty, Ltd.	MQE	Class II	2017-12-15
K171483	ArchFlo CT Midline	Medcomp (dba Medical Components, Inc.)	PND	Class II	2017-12-15
K171271	Polyform Synthetic Mesh	Boston Scientific Corporation	OTO	Class II	2017-12-15
K170913	Composite Removable Sinus Stent System	STS Medical Ltd	LYA	Class I	2017-12-15
K170497	V10	Mediana Co., Ltd.	DXN	Class II	2017-12-15
K170029	FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile	International Biophysics Corp.	KFM	Class II	2017-12-15
K163607	ECG Acquisition Systems	Vales & Hills Biomedical Tech., Ltd.	DPS	Class II	2017-12-15
K173550	Akros FibuLink™ Syndesmosis Repair Kit	Akros Medical	HTN	Class II	2017-12-14
K173434	2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300	JVCKENWOOD Corporation	PGY	Class II	2017-12-14
K173286	Cannulated Screw Internal Fixation System	Life Spine	HWC	Class II	2017-12-14
K173043	Holycon Synthetic Absorbable Sutures	Nantong Holycon Medical Devices Co., Ltd.	GAM	Class II	2017-12-14
K173013	WishBone K-Wire System	Wishbone Medical, Inc.	HTY	Class II	2017-12-14
K172863	Infinix-i, INFX-8000V, V7.0	Toshibamedical Systems Corporation	OWB	Class II	2017-12-14
K172854	NobelPerfect Abutments	Nobel Biocare AB	NHA	Class II	2017-12-14
K172732	E-Cube 8	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2017-12-14
K172676	NuVasive® Modulus-C Interbody System	Nu Vasive, Incorporated	ODP	Class II	2017-12-14
K172349	InFill® Interbody Fusion Device	Pinnacle Spine Group, LLC	MAX	Class II	2017-12-14
K172238	CAREline Airless Hemodialysis Blood Tubing Sets	Fresenius Medical Care Renal Therapies Group, LLC	KOC	Class II	2017-12-14
K172009	Cascadia Interbody System	K2M, Inc	MAX	Class II	2017-12-14
K171748	Vitrification Kit and Thawing Kit	Kitazato Corporation	MQL	Class II	2017-12-14
K170881	ISP Safety Huber Needle Infusion Set	Infusion Safety Products, Inc.	PTI	Class II	2017-12-14