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 2026-10-21, 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 547 of 3529

510(k) clearances, page 547 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173119	DRI OCT Triton	Topcon Corp.	OBO	Class II	2018-01-19
K172696	FORZA® XP Expandable Spacer System	Orthofix SRL	MAX	Class II	2018-01-19
K171827	ReddyPort NIV Access Elbow	SMD Manufacturing LLC	MNS	Class II	2018-01-19
K171784	Straumann Dental Implant System	Straumann USA, LLC	DZE	Class II	2018-01-19
K171731	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	Kronus, Inc.	OIF	Class II	2018-01-19
K171674	Angel Align System	Smile Development Corp	NXC	Class II	2018-01-19
K171673	Focus Cap	Gce Medical Corporation	FDF	Class II	2018-01-19
K171313	EM-4000 Specular Microscope	Tomey Corporation	NQE	Class II	2018-01-19
K171291	FUJIFILM Bronchoscope Model EB-530P	FUJIFILM Healthcare Americas Corporation	EOQ	Class II	2018-01-19
K171273	LINK® BiMobile(TM) Dual Mobility System	Waldemar Link GmbH & Co. KG	MEH	Class II	2018-01-19
K171228	Fiji Anchor	Sportwelding GmbH	MAI	Class II	2018-01-19
K173866	Stryker AIM Light Source and SafeLight cable	Stryker Corp.	OWN	Class II	2018-01-18
K173559	Barrx SB RFA Endoscopic Catheter	Medtronic, Inc.	KNS	Class II	2018-01-18
K173476	Tritanium® TL Curved Posterior Lumbar Cage	Stryker Corp.	MAX	Class II	2018-01-18
K173338	Navigated INFINITY™ Instruments	Medtronic Sofamor Danek USA Inc	OLO	Class II	2018-01-18
K172962	Nurture Rest	Neonatal Loving Kare, Inc.	OUW	Class I	2018-01-18
K172796	Flex Robotic System and Flex Transabdominal Drive	Medrobotics Corporation	HET	Class II	2018-01-18
K172791	Lumilisse IPL Hair Remover	Conair LLC.	OHT	Class II	2018-01-18
K172575	BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap	Baronova, Inc.	FED	Class II	2018-01-18
K172319	AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2018-01-18
K172259	PulsioFlex Monitoring System	Pulsion Medical Systems SE	DXG	Class II	2018-01-18
K171237	FMS VUE II Fluid Management and Tissue Debridement System	Medos International SARL	HRX	Class II	2018-01-18
K163288	Pelvifine Pelvic Muscle Trainer	Shenzhen Konmed Technology Co., Ltd	KPI	Class II	2018-01-18
K173884	Unity Total Knee System	Corin USA	JWH	Class II	2018-01-17
K173838	ARIA Radiation Therapy Management	Varian Medical Systems, Inc.	IYE	Class II	2018-01-17
K173820	OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)	Boston Scientific Corporation	OBJ	Class II	2018-01-17
K173730	Kinsa QuickCare Thermometer	Kinsa, Inc.	FLL	Class II	2018-01-17
K173582	ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes	Thermigen, Inc.	GEI	Class II	2018-01-17
K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	Novo Nordisk a/S	FMI	Class II	2018-01-17
K173113	Medline Disposable Electronic Thermometer Probe Cover	MEDLINE INDUSTRIES, LP - Northfield	FLL	Class II	2018-01-17
K173020	OBA-MCP, Orthodontic Bracket Adhesive with MCP	Pulpdent Corporation	DYH	Class II	2018-01-17
K172164	PROPEL Device	Propel Orthodontics, LLC	DZJ	Class II	2018-01-17
K171634	Ortho System	3Shape A/S	PNN	Class II	2018-01-17
K171247	epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test	Epocal Inc	CDS	Class II	2018-01-17
K170234	Endotracheal tube; Reinforced Endotracheal tube	Zhanjiang Star Enterprise Co., Ltd.	BTR	Class II	2018-01-17
K173641	Activ Ankle	Newclip Technics	HRS	Class II	2018-01-16
K173622	CS Imaging	Trophy	LLZ	Class II	2018-01-16
K173240	Arthrex PushLock	Arthrex GmbH	MAI	Class II	2018-01-16
K173054	Navigo Workstation Version 2.0	UC-Care	LLZ	Class II	2018-01-16
K172977	Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel	Nanova Biomaterials Inc	KLE	Class II	2018-01-16
K172683	Yamahachi Pink CAD/CAM Disk	Yamahachi Dental Mfg. Co.	EBI	Class II	2018-01-16
K172384	Quickie(r) Q700-UP M	Sunrise Medical, Inc.	IPL	Class II	2018-01-16
K172189	Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt	Truemed Group, LLC	HSB	Class II	2018-01-16
K171761	ACCLARENT AERA Eustachian Tube Balloon Dilation System	Acclarent Inc	PNZ	Class II	2018-01-16
K171556	K2M Navigation Instruments	K2M, Inc	OLO	Class II	2018-01-16
K171799	Elos Accurate Customized Abutment, Elos Prosthetic Screw	Elos MedTech Pinol a/S	NHA	Class II	2018-01-15
K171354	MR4 Laser	Multi Radiance Medical	NHN	Class II	2018-01-13
K173828	Gu60a & Gu60a-65	Samsung Electronics Co., Ltd.	KPR	Class II	2018-01-12
K173795	HI-TORQUE TurnTrac Guide Wire Family	Abbott Vascular	DQX	Class II	2018-01-12
K173635	syngo.via RT Image Suite	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2018-01-12