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 374 of 3528

510(k) clearances, page 374 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K200291	CREED™ Cannulated Screws	Glw Medical, Inc.	HWC	Class II	2020-12-16
DEN200035	BEAR (Bridge-Enhanced ACL Repair) Implant	Miach Orthopaedics	QNI	Class II	2020-12-16
K203401	Neocis Guidance System (NGS) with Patient Splints (EPS)	Neocis Inc.	PLV	Class II	2020-12-15
K203383	Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62	Philips Consumer Lifestyle - Innovation Site Eindhoven	HGX	Class II	2020-12-15
K202827	308nm Excimer UV-light Skin Therapy System	Shenzhen GSD Tech Co., Ltd	FTC	Class II	2020-12-15
K202698	Prefilled Syringe	Hangzhou Primecare Medical Co.,Ltd.	EZL	Class II	2020-12-15
K202601	Single-use Sterile medical laser fiber	Realton (Suzhou) Medical Technology Co., Ltd.	GEX	Class II	2020-12-15
K202337	Pulsed electromagnetic field wrap	Hi-Dow International Inc.	ILX	Class II	2020-12-15
K202230	NEXXT MATRIXX Stand Alone ALIF System	Nexxt Spine LLC	OVD	Class II	2020-12-15
K202226	Lim Precision Steerable TS, Steerable Sheath, Dilator	Keystone Heart, Ltd.	DYB	Class II	2020-12-15
K201808	X-Tack Endoscopic HeliX Tacking System	Apollo Endosurgery, Inc.	PKL	Class II	2020-12-15
K201755	WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System	SeaSpine Orthopedics Corporation	MAX	Class II	2020-12-15
K200971	308nm Excimer System	Xuzhou Kernel Medical Equipment Co Ltd	FTC	Class II	2020-12-15
K192709	Fixone All Suture Anchor	Aju Medical Co., Ltd.	MBI	Class II	2020-12-15
K202657	Javelin Tailor's Bunion Fixation System	Nvision Biomedical Technologies, Inc	HRS	Class II	2020-12-14
K202641	DNA/RNA Shield Collection Tube	Zymo Research	QBD	Class II	2020-12-14
K202610	Ventrax Delivery System	Merit Medical Systems, Inc.	DQY	Class II	2020-12-14
K202467	Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads	Fengh Medical Co., Ltd.	GDW	Class II	2020-12-14
K202324	Fingertip Pulse Oximeter	Shenzhen BSX Technology Electronics Co.,Ltd	DQA	Class II	2020-12-14
K202222	Irrisept Wound Debridement and Cleansing System	IrriMAX Corporation	FQH	Class II	2020-12-14
K201735	PlaDuo System	ShenB Co., Ltd.	GEI	Class II	2020-12-14
K201629	Medical Face Mask	Shandong Shengquan New Material Co., Ltd.	FXX	Class II	2020-12-14
K201495	Maxxi Flow Sensor	Neurovirtual USA, Inc.	MNR	Class II	2020-12-14
K201284	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use	Set Medikal Sanayi ve Ticaret Anonim Sirketi	FMF	Class II	2020-12-14
K201084	Physica system	Lima Corporate S.p.A.	MBH	Class II	2020-12-14
K200374	Columbus Guidewire	Rapid Medical Inc.	MOF	Class II	2020-12-14
K203487	Drakon and Sequre Microcatheters	Accurate Medical Therapeutics, Ltd.	DQO	Class II	2020-12-11
K203458	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	JOJ	Class II	2020-12-11
K203090	ELEOS Limb Salvage System featuring BIOGRIP	Onkos Surgical, Inc.	JDI	Class II	2020-12-11
K202684	GMK Total Knee System - TiNbN Coating	Medacta International SA	JWH	Class II	2020-12-11
K202471	exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft	Peca Labs, Inc.	DSY	Class II	2020-12-11
K202275	CorPath GRX System	Corindus, Inc.	DXX	Class II	2020-12-11
K201658	Hamilton-C6	Hamilton Medical AG	CBK	Class II	2020-12-11
K201354	TENS & Pms	Hong Qiangxing (Shenzhen) Electronics Limited	NGX	Class II	2020-12-11
K201046	Automated ankle brachial pressure index measuring device, MESI mTABLET system	Mesi d.o.o.; Mesi, Development of Medical Devices, Ltd.	JOM	Class II	2020-12-11
K200996	3M Attest Rapid Readout Biological Indicator	3M Company	FRC	Class II	2020-12-11
K200940	BeamSite	Doseoptics LLC	IYE	Class II	2020-12-11
K192916	NOVA Lite DAPI dsDNA Crithidia luciliae Kit	Inova Diagnostics, Inc.	KTL	Class II	2020-12-11
K203333	Triever20 Curve Catheter	Inari Medical, Inc.	QEW	Class II	2020-12-10
K203285	3M Comply Hydrogen Peroxide Indicator Tape 1228	3M Company	JOJ	Class II	2020-12-10
K203042	Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I	Canon Medical Systems Corporation	JAK	Class II	2020-12-10
K202834	da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)	Intuitive Surgical, Inc.	NAY	Class II	2020-12-10
K202673	X-cera Pre-shaded Zirconia Blanks	Dongguan Xiangtong Co., Ltd.	EIH	Class II	2020-12-10
K202635	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	LXC	Unclassified	2020-12-10
K202560	AquaPulse Irrigation Tubing	GA Health Company Limited	OCX	Class II	2020-12-10
K202334	Neuronaute	Bioserenity SAS	GWQ	Class II	2020-12-10
K202231	Jade	OrbusNeich Medical (Shenzhen) Co., Ltd.	LIT	Class II	2020-12-10
K201745	Deep Learning Image Reconstruction for Gemstone Spectral Imaging	GE Healthcare	JAK	Class II	2020-12-10
K201519	PROFEMUR® GLADIATOR® Cemented Classic Stem	Microport Orthopedics Inc.	JDI	Class II	2020-12-10
K200376	Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration	Navbit Pty Ltd	OLO	Class II	2020-12-10