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 2026-10-12, 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 243 of 3528

510(k) clearances, page 243 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222437	Aristotle Colossus Guidewire	Scientia Vascular	MOF	Class II	2023-01-26
K222403	Surgical Gown	Guangzhou Fuzelong Hygiene Material Co.,Ltd.	FYA	Class II	2023-01-26
K222056	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee	Howmedica Osteonics Corp., dba Stryker Orthopaedics	JDI	Class II	2023-01-26
K221949	Ortho Device, ADAPTIX 3D Orthopedic Imaging System	PAUSCH Medical GmbH	IZF	Class II	2023-01-26
K221619	ECHELON Oval V6.2 MRI System	Fujifilm Healthcare Corporation	LNH	Class II	2023-01-26
K221424	Sterile Surgical Powder Free Latex Glove	New Era Medicare Sdn Bhd	KGO	Class I	2023-01-26
K220073	Rmf-2000	DRTECH Corporation	MUE	Class II	2023-01-26
K223866	Carevix™ Suction Cervical Stabilizer	Aspivix SA	HDC	Class II	2023-01-25
K223847	CREED™ Cannulated Screws	Glw, Inc.	HWC	Class II	2023-01-25
K223563	OsteoCNX	Converg Engineering	MQV	Class II	2023-01-25
K223314	Disposable Blood Lancets	Huaian Hening Medical Instruments Co., Ltd.	QRK	Class II	2023-01-25
K223306	SPRINT Peripheral Nerve Stimulation (PNS) System	SPR Therapeutics, Inc	NHI	Class II	2023-01-25
K222801	Safety Lancet	Sarstedt AG & Co. KG	FMK	Class II	2023-01-25
K222665	Medline UNITE® Ankle Fusion Plating System	MEDLINE INDUSTRIES, LP - Northfield	HRS	Class II	2023-01-25
K221150	Advanced Bone Plate	Double Medical Technology Inc.	HRS	Class II	2023-01-25
K220114	PowerPAK Syringe	Vault Paragon Group, Inc.	MEG	Class II	2023-01-25
K222879	Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)	Wuxi Jiajian Medical Instrument Co., Ltd	GZJ	Class II	2023-01-24
K222818	Xpedition ™ Powered Stair Chair (625700000000)	Stryker Medical	ILK	Class II	2023-01-24
K223494	CD Horizon Spinal System	Medtronic, Inc.	NKB	Class II	2023-01-23
K223313	Disposable Safety Lancets	Huaian Hening Medical Instruments Co., Ltd.	FMK	Class II	2023-01-23
K223158	LigaSure™ XP Maryland Jaw Sealer/Divider	Medtronic, Inc.	GEI	Class II	2023-01-23
K222406	Clarius AI	Clarius Mobile Health Corp	QIH	Class II	2023-01-23
K221494	Quality Mix Blender, Oxymixer	DEHAS Medical Systems GmbH	BZR	Class II	2023-01-23
K203689	Tidepool Loop	Tidepool Project	QJI	Class II	2023-01-23
K222531	Synthetic Polymer Glove - Polyethylene (Black)	Ur Industry Sdn Bhd	LZA	Class I	2023-01-22
K223516	Vx1+	Volta Medical	DQK	Class II	2023-01-21
K223118	OIC Variable Angle Small Fragment Locking Plate System	The Orthopaedic Implant Company	HRS	Class II	2023-01-21
K222832	Sentimag System	Endomagnetics Ltd	NEU	Class II	2023-01-21
K223842	DRX - Compass	Eastman Kodak Company	KPR	Class II	2023-01-20
K223548	GMK Sphere & GMK SpheriKA Cementless	Medacta International SA	MBH	Class II	2023-01-20
K223528	Triathlon® Hinge Knee System	Howmedica Osteonics Corp., dba Stryker Orthopaedics	KRO	Class II	2023-01-20
K223521	ZESPIN SI Joint Fusion System	Aegis Spine, Inc.	OUR	Class II	2023-01-20
K223404	Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V	Quanta System Inc.	GEX	Class II	2023-01-20
K223177	Highlander™ 014 PTA Balloon Dilatation Catheter	C.R. Bard Inc	LIT	Class II	2023-01-20
K222889	FlowArt® Needle-Free Split Septum Valve	Asset Medikal Tasarim San. Tic. A.S.	FPA	Class II	2023-01-20
K222848	pRESET Thrombectomy Device	Phenox Inc	POL	Class II	2023-01-20
K222510	Blueprint Mixed Reality system	Tornier S.A.S.	OLO	Class II	2023-01-20
K222462	Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)	Itp Innovative Tomography Products GmbH	KNW	Class II	2023-01-20
K222158	Capiflo 5001	K&L Distributing, Inc.	JOW	Class II	2023-01-20
K221899	The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml	Thermo Fisher Scientific Oy	NGZ	Class II	2023-01-20
K221725	Advanced MyHip Planner	Medacta International SA	LLZ	Class II	2023-01-20
K221683	CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)	Olympus Medical Systems Corp.	FAJ	Class II	2023-01-20
K221419	TD-5010 Lancing Device and TD-5084 Sterile Lancets	Gostar Co., Ltd.	QRL	Class II	2023-01-20
K214077	Digital Thermometer, Model: DT007, DT008	Guangzhou Berrcom Medical Device Co., Ltd	FLL	Class II	2023-01-20
K203792	Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle	PIKDARE S.p.A.	FMI	Class II	2023-01-20
K223872	Low Profile Companion Sheath	Merit Medical Systems, Inc.	DYB	Class II	2023-01-19
K223540	AvalancheLase Family	Fotona d.o.o.	GEX	Class II	2023-01-19
K223503	Access 25(OH) Vitamin D Total	Siemens Healthcare Diagnostics Inc.	MRG	Class II	2023-01-19
K223250	Disposable Nitrile Examination Glove	Yangzhou Saraguard Medical Supplies Co., Ltd.	LZA	Class I	2023-01-19
K223166	Medaica M1 Telehealth Stethoscope	Medaica Inc	DQD	Class II	2023-01-19