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 338 of 3528

510(k) clearances, page 338 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210154	Labat series Diagnostic Ultrasound System	Shenzhen Wisonic Medical Technology Co., Ltd.	IYN	Class II	2021-07-30
K203796	Firefly Needleless Connector	Puracath Medical, Inc.	FPA	Class II	2021-07-30
K203700	Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30	Oxoid Limited (Part of Thermo Fisher Scientific)	JTN	Class II	2021-07-30
K203408	Summit Patella Plating System	Endeavor Orthopaedics. LLC	HRS	Class II	2021-07-30
K203224	Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform	Edwards Lifesciences LLC	QAQ	Class II	2021-07-30
K202780	Sectum	Neauvia North America, Inc	PBX	Class II	2021-07-30
K202208	BeneHold Surgical Incise Drape with CHG antimicrobial	Avery Dennison Belgie Bvba	KKX	Class II	2021-07-30
K201761	FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)	Abbott Medical	QLG	Class II	2021-07-30
K200770	Mini PCNL-System	Trokamed GmbH	FED	Class II	2021-07-30
K211664	GMK Sphere Revision	Medacta International SA	JWH	Class II	2021-07-29
K211663	Zap-X Radiosurgical System	Zap Surgical Systems Inc.	IYE	Class II	2021-07-29
K211341	Blue Nitrile Exam Gloves	Jiangxi Surefine Medical Co., Ltd.	LZA	Class I	2021-07-29
K211317	Cruxview	Cruxell Corp.	MUH	Class II	2021-07-29
K211314	OCS Lung Solution	Transmedics, Inc.	MSB	Class II	2021-07-29
K211229	Vinyl compound examination gloves	Hebei Titans Hongsen Medical Technology Co.,Ltd	LYZ	Class I	2021-07-29
K211131	Disposable Nitrile Medical Examination Glove	Siyang Threeguard Medical Supplies Co., Ltd.	LZA	Class I	2021-07-29
K210953	SMART Taylor Spatial Frame	Smith & Nephew, Inc.	KTT	Class II	2021-07-29
K210862	Hemafuse System	Sisu Global Health	CAC	Class II	2021-07-29
K210770	Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2021-07-29
K210574	NuVasive Pulse System	Nu Vasive, Incorporated	OLO	Class II	2021-07-29
K210115	FiteBac CC OrthoSeal	Largent Health, LLC	DYH	Class II	2021-07-29
K203753	Straumann Surgical Cassettes	Straumann USA, LLC	KCT	Class II	2021-07-29
K202825	BTI Extra-Short Dental Implant System UnicCa	B.T.I. Biotechnology Institute, S.L.	DZE	Class II	2021-07-29
K211994	Braun Silk.expert Mini	Cyden Limited	OHT	Class II	2021-07-28
K211991	Catalyst R1 Reverse Shoulder System	CATALYST ORTHOSCIENCE Inc	PHX	Class II	2021-07-28
K211875	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach	William Cook Europe ApS	DTK	Class II	2021-07-28
K211874	Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	William Cook Europe ApS	DTK	Class II	2021-07-28
K211861	TAIJI Professional Series Level 3 Surgical Face Mask	Taiji Medical Supplies, Inc.	FXX	Class II	2021-07-28
K211839	Electrode Market Disposable Surface Electrodes	Electrode Market Co., Ltd.	GXY	Class II	2021-07-28
K211677	ELEOS Limb Salvage System	Onkos Surgical, Inc.	KRO	Class II	2021-07-28
K211646	FINE Osteotomy	Bodycad Laboratories, Inc.	HRS	Class II	2021-07-28
K211497	Surgical Mask	Honeywell Safety Products	FXX	Class II	2021-07-28
K211489	Dental Impression Material	Nanchang Dental Bright Technology Co., Ltd.	ELW	Class II	2021-07-28
K211455	Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors	Shen Wei (USA), Inc.	LZA	Class I	2021-07-28
K211395	Nio-I	Einstein Works, LLC	FMI	Class II	2021-07-28
K211335	Diode Laser Machine, Model Number: BM-100	Zhengzhou Bestview ST Co., Ltd.	GEX	Class II	2021-07-28
K211225	MIS Ti-base abutment	Dentsply Sirona Inc	NHA	Class II	2021-07-28
K211129	Neocis Guidance System (NGS) with Intraoral Fiducial Array	Neocis Inc.	PLV	Class II	2021-07-28
K211014	Portray	Surround Medical Systems	EHD	Class II	2021-07-28
K210856	Purism Disposable Surgical Mask	Chuzhou Daddy'S Choice Science and Technology Co., Ltd.	FXX	Class II	2021-07-28
K210409	Disposable Surgical Face Mask	Shandong Zhushi Pharmaceutical Group Co., Ltd	FXX	Class II	2021-07-28
K210379	Broncho Videoscope System	Scivita Medical Technology Co., Ltd.	EOQ	Class II	2021-07-28
K210189	Pac-Dent Denture Base Resin	Pac-Dent Inc.	EBI	Class II	2021-07-28
K203431	Disposable Ear Thermometer Probe Cover	Huaian Zhongxin Packing Material Co., Ltd.	FLL	Class II	2021-07-28
K203359	BD Flu+ Syringe	Becton Dickinson & Co	FMF	Class II	2021-07-28
K201657	Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads	Corin, Ltd.	LZO	Class II	2021-07-28
K212074	ClariCT.AI	Claripi Inc.	LLZ	Class II	2021-07-27
K211990	Rist 071 Radial Access Guide Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	DQY	Class II	2021-07-27
K211989	Aveir Introducer	Abbott Medical	DYB	Class II	2021-07-27
K211932	Fixxsure Anterior Lumbar Plate and Screw System	Oak Tree Engineering, LLC	KWQ	Class II	2021-07-27