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 601 of 3529

510(k) clearances, page 601 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163300	ThermoShield HME Filter	Flexicare Medical Ltd.	CAH	Class II	2017-03-22
K163109	OxyHeal 4000 Multiplace Hyperbaric Chamber Family	Oxyheal Medical Systems, Inc.	CBF	Class II	2017-03-22
K163099	My Dose Coach	Sanofi S.r.l.	NDC	Class II	2017-03-22
K163017	Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs	GMP Medicare Sdn Bhd	LZC	Class I	2017-03-22
K161979	ENFit enteral syringe	Jiangyin Caina Technology Co., Ltd.	PNR	Class II	2017-03-22
K161141	ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT	Pentaferte Italia S.r.l.	PNR	Class II	2017-03-22
K163637	BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)	Becton Dickinson & Co	LON	Class II	2017-03-21
K163608	HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm	Biostable Science & Engineering, Inc.	PST	Class II	2017-03-21
K163405	360KS Implant Positioning System	Kico Knee Innovation Company	LLZ	Class II	2017-03-21
K163401	Nix Ultra Lice Treatment Kit	MedTech Products, Inc.	LJL	Class I	2017-03-21
K163343	Icare HOME tonometer	Icare Finland Oy	HKY	Class II	2017-03-21
K163320	LAP-Pump PP110	Novanta Medical GmbH	HET	Class II	2017-03-21
K163296	SOMATOM go.Up, SOMATOM go.Now	Siemens Medical Solutions USA, Inc.	JAK	Class II	2017-03-21
K163157	SmartGrid	Eastman Kodak Company	MQB	Class II	2017-03-21
K162758	VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack	STERIS Corporation	JOJ	Class II	2017-03-21
K162740	MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2017-03-21
K152534	Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System	Tianjin Empecs Medical Device Co., Ltd.	NBW	Class II	2017-03-21
K170539	Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm	Avitus Orthopaedics, Inc	KNW	Class II	2017-03-20
K170296	CoreCath 2.7S	Medtronic Navigation, Inc	GEI	Class II	2017-03-20
K163488	Flex-Thread Clavicle Pin System	Intrafuse, LLC	HSB	Class II	2017-03-20
K163323	Dolphix® External Fixation System MR Conditional	Citieffe Inc.	KTT	Class II	2017-03-20
K163175	Bel-Cypher Pro	Takara Belmont Corporation	MUH	Class II	2017-03-20
K163162	Sterile Hypodermic Safety Syringes for Single Use	Jiangxi Hongda Medical Equipment Group Ltd.	MEG	Class II	2017-03-20
K163161	Sterile Single-use Syringe with Needle	Jiangxi Hongda Medical Equipment Group Ltd.	FMF	Class II	2017-03-20
K161691	Direct LDL Cholesterol (LDL)	Randox Laboratories, Limited	MRR	Class I	2017-03-20
K161318	Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems	Tedan Surgical Innovations, Inc.	GZT	Class II	2017-03-20
K160139	Luggie Chair	Freerider, Corp.	ITI	Class II	2017-03-20
K170583	Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface	Medtronic, Inc.	DTN	Class II	2017-03-17
K170501	CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver	ConMed Corporation	MAI	Class II	2017-03-17
K163655	Sparkling	Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	GEX	Class II	2017-03-17
K163586	Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector	Trovrx, Inc. dba Trovita Health Science	PIF	Class II	2017-03-17
K163569	Elecsys CMV IgM	Roche Diagnostics GmbH	LFZ	Class II	2017-03-17
K163378	Monarch Airway Clearance System	Hill-Rom Services Pte, Ltd.	BYI	Class II	2017-03-17
K163346	MAZIC Duro	Vericom Co., Ltd.	EBF	Class II	2017-03-17
K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	GE Healthcare	LNH	Class II	2017-03-17
K163239	SMARTmatic	Kaltenbach & Voigt GmbH	EFA	Class I	2017-03-17
K162898	Olecranon Plating System	Miami Device Solutions, LLC	HRS	Class II	2017-03-17
K162868	Exam Vue PACS	Jpi Healthcare Solutions, Inc.	LLZ	Class II	2017-03-17
K162562	Opt-Shield Air, Supine; Opt-Shield, Lithotomy	BCG Medical, LLC	DWJ	Class II	2017-03-17
K162522	UltraCath Continuous Nerve block Catheter	Teleflexmedical, Inc.	BSO	Class II	2017-03-17
K162308	Noris Medical MBI-2mm Dental Implant System	Noris Medical Ltd.	DZE	Class II	2017-03-17
K161250	OC-FLEX Flexible IntraOral Cannula	Venture Therapeutics, Inc.	CCK	Class II	2017-03-17
K161077	RnD TE and RnD SE	Apex Dental Materials, Inc.	KLE	Class II	2017-03-17
K153600	Consult Station TS	H4D SAS	DXN	Class II	2017-03-17
K170455	MectaLIF Anterior Stand Alone	Medacta International SA	OVD	Class II	2017-03-16
K170451	FDX Console (DR-ID300CL) Software	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2017-03-16
K163498	VALIDATE Heparin Calibration Verification/Linearity Test Kit	Maine Standards Co.	GGN	Class II	2017-03-16
K163471	Kalitec Direct InSePtion™ MIS Fixation System	Kalitec Direct, LLC	PEK	Class II	2017-03-16
K163230	NuVasive Modulus XLIF Interbody System	Nu Vasive, Incorporated	MAX	Class II	2017-03-16
K163201	KYMCO EQ10D Scooter	Kwang Yang Motor Co., Ltd.	INI	Class II	2017-03-16