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 381 of 3528

510(k) clearances, page 381 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K200071	Blue Beacon Submucosal Injectable Solution	Micro-Tech (Nanjing) Co., Ltd.	PLL	Class II	2020-11-03
K191940	Palm NRG cellulite and muscle toning body device	Heat in a Click LLC	PBX	Class II	2020-11-03
K203032	IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle	Galil Medical Ltd.	GEH	Class II	2020-11-02
K202562	Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set	Ellusa, LLC	GEI	Class II	2020-11-02
K202558	Ellusa Bipolar Wands	Ellusa, LLC	GEI	Class II	2020-11-02
K202552	Midas Rex Attachments and Dissecting Tools	Medtronic Powered Surgical Solutions (Mpss)	OLO	Class II	2020-11-02
K192904	SpeediCath Compact Set	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2020-11-02
K192618	e-Motion M25	Alber GmbH	ITI	Class II	2020-11-02
K203028	FUJIFILM Distal End Cap	FUJIFILM Corporation	FDT	Class II	2020-10-30
K203007	eKuore Pro Series	Chip Ideas Electronics S.L.	DQD	Class II	2020-10-30
K202938	Aesculap Caiman 5 Seal and Cut Technology System	Aesculap Inc	GEI	Class II	2020-10-30
K202901	Longeviti ClearFit Cranial Implant	Longeviti Neuro Solutions	GXN	Class II	2020-10-30
K202556	HS30 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2020-10-30
K202497	Aulisa Multiple Patient Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	MSX	Class II	2020-10-30
K202302	Atlas Spine Rebar (Ti) Spacer System	Atlas Spine, Inc.	ODP	Class II	2020-10-30
K202157	PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack	Smith & Nephew Medical Ltd	OMP	Class II	2020-10-30
K202013	WRDensity by Whiterabbit.ai	Whiterabbit.Ai, Inc.	QIH	Class II	2020-10-30
K201988	T-Lite	Sonoscanner	IYN	Class II	2020-10-30
K201695	Patent Hemostasis Band (PH Band)	Medical Ingenuities	DXC	Class II	2020-10-30
K200323	AutoContour	Radformation, Inc.	QKB	Class II	2020-10-30
K200316	UNiD IB3D ALIF	Medicrea International	MAX	Class II	2020-10-30
K200190	ScalpelCric	VBM Medizintechnik GmbH	BWC	Class II	2020-10-30
K193421	Smart Alarm Interface	Boxview, LLC	MSX	Class II	2020-10-30
K193296	eCordum Cardiac Monitor (eCordum CM)	Ecordum, Inc.	DXH	Class II	2020-10-30
K203058	CloudVue	International Medical Solutions Inc.	LLZ	Class II	2020-10-29
K202957	Flexible Video Cysto-Urethroscope (C-view)	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	2020-10-29
K202949	CONSTRUX Mini PEEK Spacer System	Orthofix SRL	ODP	Class II	2020-10-29
K202912	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	HRS	Class II	2020-10-29
K202646	Visera Elite II Video System Center	Olympus Medical Systems Corp.	FET	Class II	2020-10-29
K202539	Nutriglide(TM) Nasal Feeding Tube	Applied Medical Technology Inc	KNT	Class II	2020-10-29
K202496	ANTHEM Fracture System	Globus Medical, Inc.	HRS	Class II	2020-10-29
K202142	Sleepware G3	Respironics, Inc.	OLZ	Class II	2020-10-29
K202105	OsteoMed ExtremiFix Mini & Small System Tray	Osteomed	KCT	Class II	2020-10-29
K201692	NuVasive Modulus XLIF Interbody System	Nu Vasive, Incorporated	MAX	Class II	2020-10-29
K201092	Lsn	Imaging Biometrics, LLC	JAK	Class II	2020-10-29
K200425	Female Luer Lock Cap	Medsafety Solutions LLC	FPA	Class II	2020-10-29
K200332	EXPERT - Joint Fixation System	GM dos Reis Industria e Comercio Ltda	HTN	Class II	2020-10-29
K200299	Curos Jet Disinfecting Cap	3M Company	QBP	Class II	2020-10-29
K200088	g.Estim FES	G.tec Medical Engineering GmbH	IPF	Class II	2020-10-29
K193206	WiZARD 510 Nasal Mask	Apex Medical, Inc.	BZD	Class II	2020-10-29
K193169	Nelson Sentinel Series Basic Chlorine Sentinel	Nelson Environmental Technologies, Inc.	MSY	Class II	2020-10-29
K193090	HCG Zirconia Ceramic Block	Hocheng Corporation	EIH	Class II	2020-10-29
K192989	Libertas E-XLPE Modular Liner	Maxx Orthopedics Inc.	OQI	Class II	2020-10-29
K192282	MedCAD® AccuPlan® System	MedCAD	DZJ	Class II	2020-10-29
K202935	Syntec Femoral Nail Extended System	Syntec Scientific Corp.	HSB	Class II	2020-10-28
K202864	Tri-Staple 2.0 Reloads	Medtronic, Inc.	GDW	Class II	2020-10-28
K202259	Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip	Parcus Medical, L.L.C.	MBI	Class II	2020-10-28
K202089	LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer	Bonraybio Co., Ltd.	POV	Class II	2020-10-28
K201497	EVOS Cabling System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	JDQ	Class II	2020-10-28
K201475	Ultimate Contour, Ultimate Contour Mini	Cao Group, Inc.	PBX	Class II	2020-10-28