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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 686 of 3530

510(k) clearances, page 686 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K150741	TSolution One w/ACG surgical System	Think Surgical Inc.	OJP	Class II	2015-10-22
K150314	Masimo MightySat Rx Fingertip Pulse Oximeter	Masimo Corporation	DQA	Class II	2015-10-22
K152867	MHI-TM2000 Linear Accelerator System, VERO, Imavis	Mitsubishi Heavy Industries, Ltd.	IYE	Class II	2015-10-21
K152788	EOS System	EOS imaging	KPR	Class II	2015-10-21
K152770	ProBP 2400 Digital Blood Pressure Device	Microlife Intellectual Property GmbH	DXN	Class II	2015-10-21
K152763	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2015-10-21
K152726	JOURNEY II XR Knee System	Smith & Nephew, Inc.	JWH	Class II	2015-10-21
K152709	Hi-Torque Balance	Abbott Vascular	DQX	Class II	2015-10-21
K152704	iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2015-10-21
K152694	Diamondback 360 Peripheral Orbital Atherectomy System	Cardiovascular Systems Incorporated	MCW	Class II	2015-10-21
K152693	CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels	Boston Scientific Corporation	DRQ	Class II	2015-10-21
K152261	PICC Tip Positioning Aid	Nostix, LLC	LJS	Class II	2015-10-21
K152066	Luminesse Anterior Zirconia AT	Talladium Inc	EIH	Class II	2015-10-21
K151942	Evs 3643	DRTECH Corporation	MQB	Class II	2015-10-21
K151938	S4 Cervical Spinal and Occiput Systems	Aesculap Inc	NKG	Class II	2015-10-21
K151836	Nitrile Powder Free Examination Gloves-Pink, Nitrile Powder Free Examination Gloves-Green,nitrile Powder Free Examination Gloves-Orange, Nitrile Powder Free Examination Gloves-Black	Hartalega NGC Sdn Bhd	LZA	Class I	2015-10-21
K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	DXJ	Class II	2015-10-21
K151646	ProTech Plus	Protech Professional Products, Inc.	EBI	Class II	2015-10-21
K151415	Oregon Scientific	Idt Technology Limited	DXN	Class II	2015-10-21
K150855	H-MAX S Femoral Hip System	Lima Corporate S.p.A.	MEH	Class II	2015-10-21
K150474	NuVasive VuePoint II OCT System	Nu Vasive, Incorporated	NKG	Class II	2015-10-21
K142505	ClearPoint System	Mri Interventions, Inc.	HAW	Class II	2015-10-21
K152574	Navio	Blue Belt Technologies, Inc.	OLO	Class II	2015-10-20
K152014	MTS300 Multiple Tray Sterilization System	Pmbs, LLC	KCT	Class II	2015-10-20
K151956	Admira Fusion x-tra	Voco GmbH	EBF	Class II	2015-10-20
K151674	Ultraviolet Sun Tanning Lamp	G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse mbH	LEJ	Class II	2015-10-20
K151389	Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2015-10-20
K150308	Palm TENS	Heat in a Click LLC	NUH	Class II	2015-10-20
K150160	Temple Touch Pro (TTP) Non-invasive temperature monitoring system	Medisim Ltd.	FLL	Class II	2015-10-20
K150153	Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant	Package Solutions, LLC	NUC	Class II	2015-10-20
K152156	Opticage Expandable Interbody Fusion Device	Interventional Spine, Inc.	MAX	Class II	2015-10-19
K151636	AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control	Advanced Medical Optics, Inc.	HQC	Class II	2015-10-19
K150804	QBioScan	Medeia Inc	GZO	Class II	2015-10-19
K150232	Radifocus Optitorque Angiographic Catheter	Ashitaka Factory of Terumo Corp.	DQO	Class II	2015-10-19
K150156	Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel	Ranfac Corp.	MUU	Class II	2015-10-19
K143617	AquaC UNO H	Vivonic GmbH	FIP	Class II	2015-10-19
K152687	Arm-Type Fully Automatic Digital Blood Pressure Monitor	Sejoy Electronics & Instruments Co., Ltd.	DXN	Class II	2015-10-16
K152663	Bladeless Optical Obturators	Intuitive Surgical, Inc.	GCJ	Class II	2015-10-16
K152362	Terumo SurGuard 3 Safety Hypodermic Needle	Terumo (Philippines) Corporation	FMI	Class II	2015-10-16
K152094	Gr40cw	Samsung Electronics Co., Ltd.	MQB	Class II	2015-10-16
K151844	Rainbow Shade	GENOSS Co., Ltd.	EIH	Class II	2015-10-16
K151671	Disposable Multistage Dilation Balloon Catheter	Micro-Tech (Nanjing) Co., Ltd.	FGE	Class II	2015-10-16
K151648	Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System	Altus Partners	NKB	Class II	2015-10-16
K151640	Eltrac 471	Enraf-Nonius B.V.	ITH	Class II	2015-10-16
K151565	Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit	Cepheid	OUY	Class II	2015-10-16
K151479	EV-820 OTC Pain Relief TENS	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2015-10-16
K151347	MIS Spine Frame Instrument Case	Thompson Surgical Instruments, Inc.	KCT	Class II	2015-10-16
K150918	PASS OCT Spinal System	Medicrea International	NKG	Class II	2015-10-16
K150037	Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities	Sensus Healthcare	JAD	Class II	2015-10-16
K152710	HammerFiX Device	Extremity Medical, LLC	HWC	Class II	2015-10-15