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 629 of 3529

510(k) clearances, page 629 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152579	FilmArray Respiratory Panel EZ (RP EZ)	BioFire Diagnostics, LLC	OCC	Class II	2016-10-03
K161576	Esophagus Bougie Set	Varian Medical Systems, Inc.	JAQ	Class II	2016-10-02
K162276	SeraQuest Herpes Type 1 Specific IgG	Quest International, Inc.	MXJ	Class II	2016-10-01
K162527	8MP Color LCD Monitor (C81W+)	Shenzhen Beacon Display Technology Co., Ltd.	PGY	Class II	2016-09-30
K162187	Xario 100 Diagnostic Ultrasound System, V5.0	Toshibamedical Systems Corporation	IYN	Class II	2016-09-30
K161875	LaserCap300, LaserCap224, LaserCap120, LaserCap80	Transdermal Cap, Inc.	OAP	Class II	2016-09-30
K161803	Traxcess .007 Mini Guidewire	Terumo Cardiovascular Systems Corporation	MOF	Class II	2016-09-30
K161774	i-Sil	Spident Co., Ltd.	ELW	Class II	2016-09-30
K161608	InterForm Cervical Interbody Cage System	Next Orthosurgical	ODP	Class II	2016-09-30
K161464	Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters	Innovative Health, LLC.	NLH	Class II	2016-09-30
K161232	ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit	Halyard Health	BSO	Class II	2016-09-30
K161212	Atteris Antimicrobial Skin Protectant	Rochal Industries, LLC	FRO	Unclassified	2016-09-30
K160443	TempoCem Clear	Dmg USA, Inc.	EMA	Class II	2016-09-30
K160140	DENTRIa series	HDX Will	OAS	Class II	2016-09-30
K160023	Electronic Stethoscope DS301	Imediplus, Inc.	DQD	Class II	2016-09-30
K153156	eCareManager 4.0.1	Visicu, Inc.	MSX	Class II	2016-09-30
K151964	Xprecia Stride Coagulation System, Xprecia System PT Controls	Siemens Healthcare Diagnostics Inc.	GJS	Class II	2016-09-30
K162426	nva, nvp, and nvt	Nvision Biomedical Technologies, Inc	MAX	Class II	2016-09-29
K162416	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate	Iridex Corporation	GEX	Class II	2016-09-29
K162332	Nexcore GI Insufflator	Nexcore Technology, LLC	FCX	Class II	2016-09-29
K162126	Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)	ArthroCare Corporation	GEI	Class II	2016-09-29
K162059	Ezee Retrieval	Genicon, Inc.	GCJ	Class II	2016-09-29
K161672	SpeediCath Flex Coude	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2016-09-29
K161671	Ponto 3, Ponto 3 Power and Ponto 3 SuperPower	Oticon Medical AB	LXB	Class II	2016-09-29
K161424	Phasix Mesh	C.R. Bard Inc	OOD	Class II	2016-09-29
K161379	ELSA Spacers	Globus Medical, Inc.	OVD	Class II	2016-09-29
K160436	CreoDent Solidex Custom Abutment	Creodent Prosthetics Ltd	NHA	Class II	2016-09-29
K160410	WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head	Dental Savings Club Inc.	EFB	Class I	2016-09-29
K152163	Renasys Go	Smith & Nephew, Inc.	OMP	Class II	2016-09-29
K162417	Acuson Freestyle Ultrasound System	Siemens Medi Cal Solutions, Inc.	IYN	Class II	2016-09-28
K161562	Sound Options Tinnitus Treatment	Sound Options Tinnitus Treatments, Inc.	KLW	Class II	2016-09-28
K161442	NuVasive® CoRoent® Small Interlock™ System	Nu Vasive, Incorporated	OVE	Class II	2016-09-28
K161173	Avenue® T TLIF Cage	Ldr Spine USA	OVD	Class II	2016-09-28
K161014	NuVasive® Reline® System	Nu Vasive, Incorporated	NKB	Class II	2016-09-28
K161002	Aprima Smartesis Centesis Pump	Cook Incorporated	BTA	Class II	2016-09-28
K160365	BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2016-09-28
K160136	Flowable Wound Matrix	Cook Biotech Incorporated	KGN	Unclassified	2016-09-28
K153546	PINK CAD/CAM disc	POLIDENT d.o.o., Dental products industry	EBI	Class II	2016-09-28
K162307	OrthoPediatrics Locking Proximal Femur System Cortical Screws	Orthopediatrics Corp	HRS	Class II	2016-09-27
K162107	TPH Spectra+ Universal Composite Restorative	Dentsply Sirona Inc	EBF	Class II	2016-09-27
K161984	Interlocked Circular Small Field Collimators, Elekta Integrated	Aktina Medical Corp.	IYE	Class II	2016-09-27
K161814	Solana Influenza A+B Assay	Ortho-Clinical Diagnostics, Inc.	OCC	Class II	2016-09-27
K161446	Biopor Porous Polyethylene Implants	Ceremed, Inc.	GWO	Class II	2016-09-27
K160957	CDB Self Ligating Bracket 8F	CDB Corporation	NJM	Class II	2016-09-27
K160825	MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology	Dentsply Sirona Inc	EKX	Class I	2016-09-27
K160818	STERRAD® NX Sterilizer with ALLClear™ Technology	Advanced Sterilization Products	MLR	Class II	2016-09-27
K160630	Invacare Platinum Mobile Oxygen Concentrator	Invacare GmbH	CAW	Class II	2016-09-27
K152865	TRACOE smart Cuff Manager	Tracoe Medical GmbH	BSK	Class II	2016-09-27
K161878	PORTAGE System	Baylis Medical Co., Inc.	HRX	Class II	2016-09-26
K161838	Xenocor Xenoscope Laparoscopic System	Xenocor, Inc.	GCJ	Class II	2016-09-26