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 340 of 3528

510(k) clearances, page 340 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210176	FlowSaver Blood Filter	Inari Medical, Inc.	CAC	Class II	2021-07-22
K210143	Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)	Foshan Nanhai Plus Medical Co Ltd	FYA	Class II	2021-07-22
K203694	DELTA XTEND Reverse Shoulder System	Depuy Ireland UC	PHX	Class II	2021-07-22
K203411	syngo.CT Skull Unfolding	Siemens Medical Solutions USA, Inc.	JAK	Class II	2021-07-22
K203214	DemarkQ WOW, DemarkQ POP	Shenzhen Kaiyan Medical CO, Ltd.	OLP	Class II	2021-07-22
K203175	POLARSTEM Cemented Femoral Stem	Smith & Nephew, Inc.	LZO	Class II	2021-07-22
K202603	Temp Pal	Iweecare Co., Ltd.	FLL	Class II	2021-07-22
K202582	Arthrex SynergyID Endoscopic Imaging System	Arthrex GmbH	GCJ	Class II	2021-07-22
K211958	CD Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2021-07-21
K211901	MolecuLightDX	Moleculight Corp	QJF	Class II	2021-07-21
K211223	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	Boston Scientific Corporation	OTN	Class II	2021-07-21
K210970	Single-Use Surgical Mask Model FE2311B	Byd Precison Manufacturer Co., Ltd.	FXX	Class II	2021-07-21
K210688	AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown	O&M Halyard, Inc.	FYA	Class II	2021-07-21
K210686	Nitrile Patient Examination Glove	Yunnan Huazhiyuan Medical Technology Co., Ltd.	LZA	Class I	2021-07-21
K210059	Promisemed Insulin Pen Needle	Promisemed Hangzhou Meditech Co.,Ltd.	FMI	Class II	2021-07-21
K203534	Surgical face mask (Model: Flat Ear Loop/CN102)	Crown Name Disposable Hygiene Products Fty. Ltd.	FXX	Class II	2021-07-21
K203271	Aduro light therapy Handheld	Shenzhen Kaiyan Medical CO, Ltd.	OLP	Class II	2021-07-21
K202868	LifeSignals Multi-Parameter Remote Monitoring Platform	LifeSignals, Inc.	DRG	Class II	2021-07-21
K201009	CHIRAVAC Blood Collection Needles	Chirana T. Injecta	JKA	Class II	2021-07-21
K193352	AbutmentCAD	Exocad GmbH	PNP	Class II	2021-07-21
K211906	Vital Signs	Oxehealth Ltd	QME	Class II	2021-07-20
K211859	ACUSON Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2021-07-20
K211302	Elecsys Syphilis	Roche Diagnostics GmbH	LIP	Class II	2021-07-20
K211192	Grivamax Family of Lasers, Models 272 and 148	Leana Orders, Inc.	OAP	Class II	2021-07-20
K210719	Change Healthcare Anatomical AI	Change Healthcare Canada Company	QIH	Class II	2021-07-20
K210684	Disposable Nitrile Medical Examination Glove	Jiangsu Cureguard Glove Co., Ltd.	LZA	Class I	2021-07-20
K210666	Chest-CAD	Imagen Technologies, Inc.	MYN	Class II	2021-07-20
K210349	TKO Composite Bite Turbo Gel	Reliance Orthodontic Products, Inc.	EBF	Class II	2021-07-20
K210129	RF Thermal System	Luvo Medical Technologies, Inc.	PBX	Class II	2021-07-20
K203765	ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray	Zirkonzahn SRL	LLZ	Class II	2021-07-20
K203712	The Slide	Biotex, Inc.	LQZ	Class II	2021-07-20
K203168	LifeLens Wireless ECG Monitor	LifeLens Technologies, Inc.	DSH	Class II	2021-07-20
K211910	Z-6 Atrioseptostomy Catheter	Numed Inc	DXF	Class II	2021-07-19
K211548	POLARSTEM Calcar Reamer Guide	Smith & Nephew, Inc.	LZO	Class II	2021-07-19
K211291	Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D	Fiagon GmbH	PGW	Class II	2021-07-19
K211188	xvision Spine system (XVS)	Augmedics Ltd.	SBF	Class II	2021-07-19
K210963	ENNOVATE Spinal System	Aesculap Inc	NKB	Class II	2021-07-19
K210877	Evolve System with the T3 Applicator	Inmode Ltd.	PBX	Class II	2021-07-19
K201147	Elos® Intramedullary Nailing System	Intrauma	HSB	Class II	2021-07-19
K211239	Vinyl Patient Examination Gloves	Jiangxi Shengda Medical Technology Co., Ltd.	LYZ	Class I	2021-07-17
K211177	Powder Free Vinyl Patient Examination Gloves	Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.	LYZ	Class I	2021-07-17
K211946	Soniquence Reusable Bipolar Cable	Soniquence, LLC	GEI	Class II	2021-07-16
K211792	StitchKit	ORIGAMI SURGICAL Inc.	GAM	Class II	2021-07-16
K211592	Avanti Orthopaedics Ulnar Shortening System	Avanti Orthopaedics LLC	HRS	Class II	2021-07-16
K211525	SwiftNINJA Steerable Microcatheter	Merit Medical Systems, Inc.	KRA	Class II	2021-07-16
K211111	SureMAX-SA Cervical Standalone System	Additive Implants	OVE	Class II	2021-07-16
K210761	Velguard Surgical Face Mask	Esstee Exports Health Care Division	FXX	Class II	2021-07-16
K210544	Medtronic Extended infusion set	Unomedical A/S	FPA	Class II	2021-07-16
K210186	PacBond One	Pac-Dent Inc.	KLE	Class II	2021-07-16
K210103	Safeway, Lifelong Premium, Lifelong Matrix	Lifelong Meditech Private Limited	FMF	Class II	2021-07-16