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 541 of 3529

510(k) clearances, page 541 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172044	Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S	Cook Ireland Ltd.	FGE	Class II	2018-02-27
K172042	NeuroNav System, NeuroSmart System	Alpha Omega Engineering Ltd.	GZL	Class II	2018-02-27
K171476	SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)	Awareness Technology, Inc.	JGS	Class II	2018-02-27
K170623	ACE Hemoglobin A1c (HbA1c) Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	LCP	Class II	2018-02-27
K180327	Stryker iVAS 13g Bone Biopsy Kit	Stryker Corp.	KNW	Class II	2018-02-26
K172899	Vygon PICCs	Vygon U.S.A.	LJS	Class II	2018-02-26
K172320	Neurostructures Cavetto® Cervical Cage System	Neurostructures, Inc.	ODP	Class II	2018-02-26
K171797	TRYPTIK2 C-Plate Anterior Cervical Plate System	Spineart SA	KWQ	Class II	2018-02-26
K171668	Bluetooth blood pressure monitor	Visiomed Group SA	DXN	Class II	2018-02-26
K171637	OpClear System	Cipher Surgical Ltd	OCX	Class II	2018-02-26
K170175	Endoseal Mta	Maruchi	KIF	Class II	2018-02-26
K173643	Trilor Disks, Blocks and Arches	Bioloren SRL	EBF	Class II	2018-02-24
K180130	ELEOS™ Bipolar Acetabular System	Onkos Surgical, Inc.	KWY	Class II	2018-02-23
K173863	Ez3D-i /E3	Ewoosoft Co., Ltd	LLZ	Class II	2018-02-23
K173693	Orbitum Bone Staple Implant, X and VI	Orthovestments, LLC	JDR	Class II	2018-02-23
K173689	Ophthalmic Software Platform RX	Canon Inc. -Medical Equipment Group	NFJ	Class II	2018-02-23
K173677	InMode VLaze	Inmode MD, Ltd.	GEX	Class II	2018-02-23
K173569	Ultrasound System 1300	BK Medical ApS	IYN	Class II	2018-02-23
K173493	Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000	STERIS Corporation	FLE	Class II	2018-02-23
K173491	RTS Lesser MTP Implant System	In2bones USA, LLC	KWH	Class II	2018-02-23
K173468	Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0	Toshibamedical Systems Corporation	JAK	Class II	2018-02-23
K173320	KLS Martin L1 MMF System	KLS-Martin L.P.	JEY	Class II	2018-02-23
K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	Alfa Scientific Designs, Inc.	DKZ	Class II	2018-02-23
K173224	Spin-Swi	Spintech, Inc.	LNH	Class II	2018-02-23
K173077	Cavetto-SA Cervical Cage System	Neurostructures, Inc.	OVE	Class II	2018-02-23
K172324	Axiostat Chitosan Hemostatic Dressing	Advamedica Inc.	QSY	Unclassified	2018-02-23
K171869	Sutter CURIS RF Generator	Sutter Medizintechnik GmbH	GEI	Class II	2018-02-23
K171671	Prismaflex System 8.10	Baxter Healthcare Corporation	KDI	Class II	2018-02-23
K171601	Ultraxx Nephrostomy Balloon Catheter	Cook Incorporated	LJE	Unclassified	2018-02-23
K170540	DM-Density	Densitas Inc.	LLZ	Class II	2018-02-23
K180181	Natus Quantum	Natus Medical Incorporated	GWQ	Class II	2018-02-22
K180004	Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens	Menicon Co. Ltd.	LPL	Class II	2018-02-22
K173967	Remedy Acetabular Cup	Osteoremedies, LLC	KWL	Class II	2018-02-22
K173490	Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)	STERIS Corporation	FLE	Class II	2018-02-22
K173485	Amsco Evolution Medium Steam Sterilizer	STERIS Corporation	FLE	Class II	2018-02-22
K173402	Neocis Guidance System (NGS) with Chairside Splint	Neocis Inc.	PLV	Class II	2018-02-22
K173381	Nexxis OR	Barco N.V.	DXJ	Class II	2018-02-22
K173334	SeaSpine Spinous Process System	SeaSpine Orthopedics Corporation	PEK	Class II	2018-02-22
K173255	Talon DistalFix Humeral Nail	Orthopedic Designs North America, Inc.	HSB	Class II	2018-02-22
K173236	Sentry IVC Filter	Novate Medical, Ltd.	DTK	Class II	2018-02-22
K173067	LightForce LTS Model 1000, 1500, 2500, and 4000	LiteCure, LLC	GEX	Class II	2018-02-22
K172541	Medline Catheter Specimen Collector	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2018-02-22
K172294	Osteotomy Truss System (OTS)	4WEB Inc.	HRS	Class II	2018-02-22
K171994	Silicone Peripherally Inserted Central Venous Catheter Set/Tray	Cook Incorporated	LJS	Class II	2018-02-22
K171823	U&U Indicator tape and strip	U&u Medical Technology Co., Ltd	JOJ	Class II	2018-02-22
K171649	Straumann CARES M-Series CAD/CAM System	Straumann USA, LLC	NHA	Class II	2018-02-22
K171576	The Panthera Anti-Snoring X3 Device	Panthera Dental Inc	LRK	Class II	2018-02-22
K171568	SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty	Hans Biomed Corp.	MQV	Class II	2018-02-22
K171171	KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)	Koon Seng Sdn Bhd	LZA	Class I	2018-02-22
K180193	DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)	El.en. Electronic Engineering SpA	GEX	Class II	2018-02-21