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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 593 of 3529

510(k) clearances, page 593 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163204	A08 Power wheelchair	Kunshan Aoshida Electric Technology Co., Ltd.	ITI	Class II	2017-05-05
K163070	Kent Camera	Kent Imaging Inc	MUD	Class II	2017-05-05
K162449	Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)	Boston Scientific Corporation	NEY	Class II	2017-05-05
K161770	Rusch Silicone Foley Catheter	Teleflexmedical, Inc.	EZL	Class II	2017-05-05
K160950	Miniscav	Sedation Systems LLC	CBN	Class II	2017-05-05
DEN160033	ARK Voriconazole II Assay Test System	Ark Diagnostics Inc	PUJ	Class II	2017-05-05
K171141	Arthrex SwiveLock Anchors	Arthrex GmbH	MAI	Class II	2017-05-04
K171130	Nucleus Image Management System	Nucleushealth, LLC	LLZ	Class II	2017-05-04
K170543	VIPER PRIME™ Screws with Fenestrations	Medos International SARL	NKB	Class II	2017-05-04
K163615	Snowden-Pencer MicroLap 3mm Laparoscopic Instruments	Medtronic, Inc.	GEI	Class II	2017-05-04
K163468	Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered	Cook Ireland Ltd.	MUM	Class II	2017-05-04
K163238	Eclipse Kiss Zirconia	Ams	EIH	Class II	2017-05-04
K162496	Foundation 3D Interbody	Corelink, LLC	ODP	Class II	2017-05-04
K162330	Flex Robotic System and Flex Colorectal Drive	Medrobotics Corporation	FDF	Class II	2017-05-04
K162254	Cedic Enteral ENFit Transition Connectors	Cedic S.r.l.	PIO	Class II	2017-05-04
K162207	Restore Moisturizing Vaginal Lubricant	Good Clean Love, Inc.	NUC	Class II	2017-05-04
K171005	Silhouette Featherlift	Sinclair Pharma US, Inc.	GAW	Class II	2017-05-03
K170977	SURESHOT Distal Targeting System V4.0 Trauma Interface	Smith & Nephew, Inc.	OLO	Class II	2017-05-03
K170718	Iridex TruFocus LIO Premiere	Iridex Corporation	GEX	Class II	2017-05-03
K170440	KISSloc Suture System	Arthrosurface, Inc.	HTN	Class II	2017-05-03
K170269	Hee HR Mini	Oriental Inspiration Limited	OHT	Class II	2017-05-03
K170107	Surgi Max Ultra	Elliquence LLC	GEI	Class II	2017-05-03
K163683	A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor	A&D Company, Ltd.	DXN	Class II	2017-05-03
K163640	QZA and RS Dental Implant Systems	Trinon Titanium GmbH	DZE	Class II	2017-05-03
K163530	PrisMax Control Unit	Baxter Healthcare Corporation	KDI	Class II	2017-05-03
K163481	HALF DOME Posterior Lumbar Interbody System	Astura Medical	MAX	Class II	2017-05-03
K162952	C.T.M. Mobility Scooter	Chien TI Enterprise Co., Ltd.	INI	Class II	2017-05-03
K162756	PHAKOS Disposable Retinal Cryo Probe	Phakos	HRN	Class II	2017-05-03
K162523	The IQool System	Braincool AB	NZE	Class II	2017-05-03
K162263	Optilite Rheumatoid Factor Kit	The Binding Site Group Ltd.	DHR	Class II	2017-05-03
K162248	Asahi ViE-U Series Dialyzer	Asahi Kasei Medical Co., Ltd.	KDI	Class II	2017-05-03
K171098	AXIS Image Management System	Sonomed, Inc.	NFJ	Class II	2017-05-02
K170364	Collagen Meniscus Implant XL	Ivy Sports Medicine, LLC	OLC	Class II	2017-05-02
K170360	Navio	Blue Belt Technologies, Inc.	OLO	Class II	2017-05-02
K170308	BD MAX Extended Enteric Bacterial Panel, BD MAX System	Becton Dickinson & Co	PCH	Class II	2017-05-02
K170141	Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit	Stimwave Technologies Incorporated	GZB	Class II	2017-05-02
K170108	Xultan 5.5 Pedicle Screw System	Met One Technologies, LLC	NKB	Class II	2017-05-02
K170049	AssureTech Panel Dip Test, AssureTech Quick Cup Test	Assure Tech. (Hangzhou) Co., Ltd.	NFT	Class II	2017-05-02
K163626	ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit	Luminex Corporation	OZZ	Class II	2017-05-02
K163621	Vitoss Bioactive (BA) Injectable	DSM Biomedical, Inc.	MQV	Class II	2017-05-02
K162380	Locking Plate System	Beijing Keyi Medical Device Technology Co., Ltd.	HRS	Class II	2017-05-02
K162041	Airworks Nebulizer pe1200m	Convexity Scientific, LLC	CAF	Class II	2017-05-02
K161790	iGlucose Blood Glucose Monitoring System	Bionime Corporation	NBW	Class II	2017-05-02
K160781	Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves	Semperit Investments Asia Pte, Ltd.	KGO	Class I	2017-05-02
K170975	Televere Digital Imaging System	Televere Systems	MQB	Class II	2017-05-01
K170777	Bovie J-Plasma Precise FLEX Handpiece	Apyx Medical Corporation	GEI	Class II	2017-05-01
K170733	ScanX Intraoral View	Duerr Dental AG	MUH	Class II	2017-05-01
K170334	XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack	Revmedx Inc	PGZ	Class II	2017-05-01
K170294	VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval	Bard Access Systems, Inc.	FTL	Class II	2017-05-01
K170291	IontoDC	Soterix Medical,Inc.	EGJ	Class II	2017-05-01