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 347 of 3528

510(k) clearances, page 347 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211303	Avon Patello-femoral Joint Prosthesis	Howmedica Osteonics Corp., dba Stryker Orthopaedics	KRR	Class II	2021-06-04
K211108	Prudent 1717, Prudent 1417, Prudent 1212	PixxGen Corporation	MQB	Class II	2021-06-04
K211081	AlphaVac Multipurpose Mechanical Aspiration (MMA) System	Boston Scientific Corporation	QEZ	Class II	2021-06-04
K211028	Nitrile Patient Examination Gloves	Huayuan Medical Technology(Shangqiu) Co., Ltd.	LZA	Class I	2021-06-04
K210613	HIT Clear Aligner	CDB Corporation	NXC	Class II	2021-06-04
K210080	Dentis s-Clean s-Line Mini	Dentis Co.,Ltd	DZE	Class II	2021-06-04
K210014	Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)	Guandong Genial Technology Co., Limited	FLL	Class II	2021-06-04
K203704	Surgical face mask	Juntech (Jiaxing) Healthcare Materials Co., Ltd.	FXX	Class II	2021-06-04
K203626	SureStrip Vitrification Straw, SureLock Vitrification Straw	Allwin Medical Devices, Inc.	MQK	Class II	2021-06-04
K203388	Disposable medical mask	Everwin Toys (Dongguan)., Ltd.	FXX	Class II	2021-06-04
K202828	Surgical Green Laser System	Realton (Suzhou) Medical Technology Co., Ltd.	GEX	Class II	2021-06-04
K202763	Fix2Lock (PEEK Self Punching)	Osteonic Co., Ltd.	MBI	Class II	2021-06-04
K202596	Insulia Diabetes Management Companion	Voluntis	NDC	Class II	2021-06-04
K202217	Kendall NPWT Incision Management Device	Cardinalhealth	OMP	Class II	2021-06-04
K201842	TruBase S	TruAbutment Inc.	NHA	Class II	2021-06-04
K201309	ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium	Mecta Corporation	JXL	Class II	2021-06-04
K200694	Perfect EMS	Tenscare Ltd.	NUH	Class II	2021-06-04
K211401	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	Gyrus ACMI, Inc.	GEX	Class II	2021-06-03
K211323	ASTRA Spine System	Spinecraft LLC	NKB	Class II	2021-06-03
K210627	Breezeway II	Oscor Inc.	DYB	Class II	2021-06-03
K210604	Intellihab System	Cymedica Orthopedics, Inc.	IPF	Class II	2021-06-03
K202128	Allmed Surgical Face Masks (Ear loops)	Allmed Medical Products Co., Ltd.	FXX	Class II	2021-06-03
K200722	PCA-C1 series Patient Cable	QT Medical, Inc	DSA	Class II	2021-06-03
K211440	ASM-301 Level 3 Surgical Mask	American Surgical Mask Company, LLC	FXX	Class II	2021-06-02
K211372	Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)	Mahana Therapeutics, Inc.	QMY	Class II	2021-06-02
K211051	DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)	DePuy Synthes	HRS	Class II	2021-06-02
K210652	6MS Invisible Aligner	Sms Opco, LLC	NXC	Class II	2021-06-02
K210583	SeaSpine WaveForm™ A Interbody System	SeaSpine Orthopedics Corporation	MAX	Class II	2021-06-02
K210429	Disposable Surgical Face Mask	Jiangxi Heying Pharmaceutical Co., Ltd.	FXX	Class II	2021-06-02
K210404	Transpara 1.7.0	Screenpoint Medical	QDQ	Class II	2021-06-02
K210150	Disposable Medical mask	Hubei Wanli Protective Products Co.,Ltd	FXX	Class II	2021-06-02
K203229	NATRELLE INSPIRA Single Use Sizers for Gel Implants	Allergan	MRD	Unclassified	2021-06-02
K203190	Surgical Face Mask	Rfx+Care Manufactoring Co., Ltd.	FXX	Class II	2021-06-02
K200891	BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System	Becton Dickinson & Co	FOZ	Class II	2021-06-02
DEN200069	Cognoa ASD Diagnosis Aid	Cognoa, Inc.	QPF	Class II	2021-06-02
K210994	Arthrex Beveled FT Screws	Arthrex GmbH	HWC	Class II	2021-06-01
K200942	Well-Life Garment Electrodes (GM Series)	Well-Life Healthcare Limited	GXY	Class II	2021-06-01
K211344	MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems	Medos International SARL	HCG	Class II	2021-05-28
K211311	AtriCure Isolator® Synergy™ Surgical Ablation System	AtriCure, Inc.	OCL	Class II	2021-05-28
K211304	LINQ II Insertable Cardiac Monitor	Medtronic, Inc.	MXD	Class II	2021-05-28
K211301	Pathfinder Endoscope Overtube	Neptune Medical, Inc	FED	Class II	2021-05-28
K211261	Axis Charcot Fixation System	Extremity Medical, LLC	HWC	Class II	2021-05-28
K210917	Single Use Injection Needle	Anrei Medical (HangZhou) CO., Ltd.	FBK	Class II	2021-05-28
K210536	Irrisept Antimicrobial Wound Lavage	IrriMAX Corporation	FQH	Class II	2021-05-28
K210289	Infant Phototherapy Equipment	Bistos co., Ltd.	LBI	Class II	2021-05-28
K210188	coraCross	ReFlow Medical, Inc	DQY	Class II	2021-05-28
K210025	INVU by Nuvo	Nuvo- Group, Ltd.	LQK	Class II	2021-05-28
K203687	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index	Edwards Lifesciences LLC	DQK	Class II	2021-05-28
K202932	ABT12 multi-purpose solution	Bausch & Lomb Incorporated	LPN	Class II	2021-05-28
K200607	LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters	Waldemar Link GmbH & Co. KG	LPH	Class II	2021-05-28