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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 475 of 3528

510(k) clearances, page 475 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K182897	Velano Vascular Q2 Extension Set	Becton Dickinson Infusion Therapy Systems Inc.	FPA	Class II	2019-03-26
K181858	Electric Handpiece Motor	W & H DentalWerk Buermoos GmbH	EBW	Class I	2019-03-26
K181817	transGlideXT Expandable Introducer	Transaortic Medical, Inc.	DYB	Class II	2019-03-26
K181658	MobileECG 2 BT	Memtec Corp.	DSI	Class II	2019-03-26
K190093	Rezum Delivery Device, Rezum Generator	Nxthera (A Boston Scientific Company)	KNS	Class II	2019-03-25
K190015	Ballancer Gold, 1212	MEGO AFEK AC Ltd.	IRP	Class II	2019-03-25
K181905	AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System	Boston Scientific Corporation	PCU	Class II	2019-03-25
K181778	MUTARS Proximal Femur Replacement System	implantcast GmbH	MEH	Class II	2019-03-25
K181716	InTouch Thermal Camera	Intouch Technologies, Inc., D.B.A. Intouch Health	LHQ	Class I	2019-03-25
K183491	Arm Blood Pressure Monitor	Xuzhou Yongkang Electronic Science Technology Co., Ltd	DXN	Class II	2019-03-24
K190430	OsteoCentric Bone Plate and Screw System	Osteocentric Trauma	HWC	Class II	2019-03-22
K190252	MTS Gentamicin 0.016 - 256 µg/mL	Liofilchem S.r.l.	JWY	Class II	2019-03-22
K190104	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System	Steris Corporations	MED	Class II	2019-03-22
K183608	Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile	Scientia Vascular	MOF	Class II	2019-03-22
K183400	EnVisio Navigation Sytem	Elucent Medical Inc	NEU	Class II	2019-03-22
K183353	Telescope Guide Extension Catheter	Medtronic, Inc.	DQY	Class II	2019-03-22
K183164	uWS-MR	Shanghai United Imaging Healthcare Co., Ltd.	LLZ	Class II	2019-03-22
K183047	Nalu Neurostimulation System	Boston Scientific Neuromodulation Corporation	GZB	Class II	2019-03-22
K182948	Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs	Ansell Healthcare Products LLC	KGO	Class I	2019-03-22
K182887	Masimo Rad-67 Pulse CO-Oximeter and Accessories	Masimo Corporation	DQA	Class II	2019-03-22
K182861	Shiley Neonatal/Pediatric Tracheostomy Tube	Medtronic, Inc.	JOH	Class II	2019-03-22
K182848	ROSA ONE Spine application	MedTech LLC	OLO	Class II	2019-03-22
K182700	Nexstim Navigated Brain Therapy (NBT) System 2	Nexstim Inc.	OBP	Class II	2019-03-22
K182554	Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs	HE Chuang Plastic & Rubber Co., Ltd	LZA	Class I	2019-03-22
K182395	OARtrac System	Radialdyne, LLC	NZT	Class II	2019-03-22
K182186	CMOS Video-Rhino-Laryngoscope System	Karl Storz Endoscopy-America, Inc.	EOB	Class II	2019-03-22
K181959	HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)	Owens & Minor Halyard, Inc.	FRG	Class II	2019-03-22
K181738	Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors	Surgical Instrument Service and Savings Inc (dba Medline	DQA	Class II	2019-03-22
K181722	Polyethylene Catheter	Cook Incorporated	DQO	Class II	2019-03-22
K181624	Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line	Oridion Medical 1987 Ltd.	CCK	Class II	2019-03-22
K181360	ON-Q* Pump with Bolus	Halyard Health	MEB	Class II	2019-03-22
K181173	ELMED Laparoscopic Instruments and Accessories	Elmed Incorporated	GCJ	Class II	2019-03-22
K190431	Route 92 Medical Delivery Catheter	Route 92 Medical, Head Quarters	DQY	Class II	2019-03-21
K190425	CastleLoc-P Anterior Cervical Plate System	L&K Biomed Co.,Ltd.	KWQ	Class II	2019-03-21
K190418	NuVasive® VersaTie® System	Nu Vasive, Incorporated	OWI	Class II	2019-03-21
K190412	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	Hangzhou Clongene Biotech Co., Ltd.	NGL	Class II	2019-03-21
K190380	nvc	Nvision Biomedical Technologies, Inc	ODP	Class II	2019-03-21
K190377	UroLift System UL400	Neotract Inc	PEW	Class II	2019-03-21
K183592	ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer	Siemens Healthcare Diagnostics Inc.	PWD	Class II	2019-03-21
K183582	MPACT Extension	Medacta International SA	LPH	Class II	2019-03-21
K182918	Ballast 088 Long Sheath	Balt USA, LLC	DQY	Class II	2019-03-21
K182074	Mineral Collagen Composite Bioactive Moldable	Collagen Matrix, Inc	MQV	Class II	2019-03-21
K182064	ExpanSure Transseptal Dilation System	Baylis Medical Co., Inc.	DRE	Class II	2019-03-21
K181822	RENASYS Touch; RENASYS Y-Connector	Smith & Nephew Medical Ltd	OMP	Class II	2019-03-21
K173191	A&D Medical Blood Pressure Monitors	A&D Company, Ltd.	DXN	Class II	2019-03-21
K183575	ACUSON S3000, S2000 Diagnostic Ultrasound System	Siemens Healthineers AG	IYN	Class II	2019-03-20
K183543	ACTIV.A.C. Therapy Unit	KCI USA, Inc.	OMP	Class II	2019-03-20
K183414	Absolu	Quantel Medical	IYO	Class II	2019-03-20
K183408	Jensen Shade Effect Liquids	Jensen Industries, Inc.	EIH	Class II	2019-03-20
K183399	BD Nexiva Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2019-03-20