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 660 of 3529

510(k) clearances, page 660 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K153758	Straumann Bone Level Tapered Implants	Straumann USA, LLC	DZE	Class II	2016-03-23
K152975	VDT985US Vicks SmartTemp Thermometer	Kaz USA, Inc., A Helen of Troy Company	FLL	Class II	2016-03-23
K152933	Vesalius	Telea Electronic Engineering S.r.l.	GEI	Class II	2016-03-23
K152631	MPO Total Knee Systems MR Labeling	Microport Orthopedics Inc.	HRY	Class II	2016-03-23
K152199	RejuvatoneMD	Trophy Skin, Inc.	NFO	Class II	2016-03-23
K152090	Reprocessed Steerable Introducer	Sterilmed Inc	PNE	Class II	2016-03-23
K160521	ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm	Ethicon Endo-Surgery Inc	GDW	Class II	2016-03-22
K160362	Z-Span Plate System	Zavation	KWQ	Class II	2016-03-22
K160098	Single Use Aspiration Needle NA-U401SX	Olympus Medical Systems Corp.	FCG	Class II	2016-03-22
K153324	Ingenia 1.5T and Ingenia 1.5T S R5.2	Philips Medical Systems Nederland B.V.	LNH	Class II	2016-03-22
K152955	Great Basin Shiga Toxin Direct Test	Great Basin Scientific, Inc.	PCH	Class II	2016-03-22
K152337	cryoFORM cryoICE cryoablation probe	AtriCure, Inc.	GEH	Class II	2016-03-22
K152051	ClearMet	Mycone Dental Supply Co., T/A Keystone Industries	EBI	Class II	2016-03-22
K151754	Glide-On Vinyl Examination Gloves	MEDLINE INDUSTRIES, LP - Northfield	LYZ	Class I	2016-03-22
K143468	QbCheck	Qbtech AB	LQD	Unclassified	2016-03-22
K160420	SpeqT	Signostics Limited	IYO	Class II	2016-03-21
K160229	Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle	Cook Ireland Ltd.	FCG	Class II	2016-03-21
K160120	D-SPECT Processing and Reviewing Workstation	Spectrum Dynamics, Ltd.	KPS	Class II	2016-03-21
K153770	OS2(R)-VP Varisation Staple	In2Bones SAS	JDR	Class II	2016-03-21
K153717	Venus Versa System	Venus Concept Inc.	ONF	Class II	2016-03-21
K153554	Genesis Low Temperature Reusable Rigid Container System	Medtronic, Inc.	KCT	Class II	2016-03-21
K153510	Powder Free Polychloroprene Examination Glove Green	Terang Nusa (Malaysia) Sdn. Bhd.	LZA	Class I	2016-03-21
K153019	Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes	Bio Protech, Inc.	GXY	Class II	2016-03-21
K150566	Oniris	SAS Oniris	LRK	Class II	2016-03-21
K160524	FibroScan 530 Compact	Echosens	IYO	Class II	2016-03-18
K160513	Quanta System Surgical Laser fibers	Quanta System Inc.	GEX	Class II	2016-03-18
K160484	Optetrak Advanced Patella	Exactech, Inc.	JWH	Class II	2016-03-18
K160454	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip	AtriCure, Inc.	FZP	Class II	2016-03-18
K160208	NILE Alternative Fixation Spinal System	K2M, Inc	OWI	Class II	2016-03-18
K153741	CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test	Hangzhou Clongene Biotech Co., Ltd.	LDJ	Class II	2016-03-18
K153710	Tuxedo Digital Dental Sensor	LED Dental Inc.	MQB	Class II	2016-03-18
K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	LAF	Class II	2016-03-18
K153646	SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana	Safecare Biotech(hangzhou)co.,Ltd	DIO	Class II	2016-03-18
K152999	CorPath 200 System	Corindus, Inc.	DXX	Class II	2016-03-18
K152938	DBB-06 Hemodialysis Delivery System	Nikkiso Co., Ltd.	KDI	Class II	2016-03-18
K151845	Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)	CooperSurgical, Inc.	MPO	Class I	2016-03-18
K151749	somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2016-03-18
K151722	Slim UP ULTRA	Aime Medical, Inc.	NGX	Class II	2016-03-18
K151499	CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor	Caretaker Medical	DXN	Class II	2016-03-18
K151433	AUDICOR CA300/CC100 Analyzer with SDB	Inovise Medical, Inc.	MNR	Class II	2016-03-18
K150915	Spinaut-P	Imedicom Co., Ltd.	GEI	Class II	2016-03-18
K150588	OVA1 Next Generation	Vermillion	ONX	Class II	2016-03-18
K160462	FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch	BioFire Diagnostics, LLC	PLO	Class II	2016-03-17
K160434	ClearPoint System	Mri Interventions, Inc.	HAW	Class II	2016-03-17
K160417	Rezum System	Nxthera, Inc.	KNS	Class II	2016-03-17
K160234	Ovent	Oventus Manufacturing Pty, Ltd.	LRK	Class II	2016-03-17
K153627	NuVasive® TLX Interbody System	Nu Vasive, Incorporated	MAX	Class II	2016-03-17
K153079	Axeo 3 Patient Monitor	Axeo Medical Technologies, LLC	MWI	Class II	2016-03-17
K152935	LiDCOunity Monitor	Lidco Ltd	DXG	Class II	2016-03-17
K152814	Giraffe OmniBed Carestation CS1	Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company	FMZ	Class II	2016-03-17