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 2026-10-15, 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 446 of 3528

510(k) clearances, page 446 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191530	StoneChecker	Imaging Biometrics, LLC	LLZ	Class II	2019-09-26
K191336	PRECICE System	NuVasive Specialized Orthopedics, Inc.	HSB	Class II	2019-09-26
K190466	PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate	Shen Wei (USA), Inc.	LZA	Class I	2019-09-26
K190454	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff	Hartalega NGC Sdn Bhd	LZA	Class I	2019-09-26
K190199	SepaSperm Washing Solution, SepaSperm Solution	Kitazato Corporation	MQL	Class II	2019-09-26
K190029	Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	GCJ	Class II	2019-09-26
K182009	Dia-Proseal	Diadent Group International	KIF	Class II	2019-09-26
K192102	Thermoplastic Masks	Aktina Medical Corp.	IYE	Class II	2019-09-25
K192011	PhoeniX	Sedecal S.A.	IZL	Class II	2019-09-25
K191791	TranS1 Interbody Fusion System	TranS1	MAX	Class II	2019-09-25
K191765	OMNI TiN Coated Apex Knee™ System	Omni Life Science, Inc.	JWH	Class II	2019-09-25
K191742	ARIES MRSA Assay	Luminex Corporation	NQX	Class II	2019-09-25
K190875	EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	HQC	Class II	2019-09-25
K190536	Mediracer NCS	Mediracer Ltd.	JXE	Class II	2019-09-25
K190323	Aloe Glide Lubricant	Desert Harvest, Inc.	NUC	Class II	2019-09-25
K190022	SafeBreath Filter Mouthpiece	MD Diagnostics Ltd	CAH	Class II	2019-09-25
K183687	LifeWindow LW8 Lite	Digicare Biomedical Technology, Inc.	MWI	Class II	2019-09-25
K183675	3D Visualization System	Scivita Medical Technology Co., Ltd.	GCJ	Class II	2019-09-25
K183190	NuStat	Beeken Biomedical LLC	POD	Class II	2019-09-25
K192354	Innovasis Gibralt Spine System	Innovasis, Inc	NKG	Class II	2019-09-24
K192010	SmoothSkin BARE+	Cyden Limited	OHT	Class II	2019-09-24
K191998	Mako Total Hip Application, Mako Total Knee Application	Mako Surgical Corp.	OLO	Class II	2019-09-24
K191718	Buhlmann fCAL turbo and CALEX Cap	Buhlmann Laboratories AG	NXO	Class II	2019-09-24
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System	Medos International SARL	PGM	Class II	2019-09-24
K191006	EasiSlush	Bridge to Life Ltd	KDN	Class II	2019-09-24
K190574	Patient Assistant Model PA97000	Medtronic, Inc.	DSI	Class II	2019-09-24
K183391	Novidia Universal Bond	Nobio, Ltd.	KLE	Class II	2019-09-24
K192322	T-Stat 2.0 Microvascular Tissue Oximeter	Spectros Corporation	MUD	Class II	2019-09-23
K190483	SPIRA Open Matrix ALIF and LLIF	Camber Spine Technologies	MAX	Class II	2019-09-23
K190100	USTAR II System	United Orthopedic Corp.	KRO	Class II	2019-09-23
K182671	Medi-Direct TENS Pen	JKH USA, LLC	NUH	Class II	2019-09-21
K192402	syngo.CT Extended Functionality	Siemens Medical Solutions USA, Inc.	JAK	Class II	2019-09-20
K192332	ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath	Inari Medical, Inc.	QEW	Class II	2019-09-20
K192301	BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip	Shenzhen Bioeasy Biotechnology Co., Ltd.	NFW	Class II	2019-09-20
K192296	Medtronic 6F Taiga Guiding Catheter	Medtronic, Inc.	DQY	Class II	2019-09-20
K192276	Merge Cardio	Merge Healthcare Incorporated	LLZ	Class II	2019-09-20
K192259	Philips IntelliSite Pathology Solution	Philips Electronics Nederland B.V.	PSY	Class II	2019-09-20
K191927	Hinged Laminoplasty System	Life Spine	NQW	Class II	2019-09-20
K191679	Omnipod DASH Insulin Management System with interoperable technology	Insulet Corporation	QFG	Class II	2019-09-20
K191324	CivaDerm	CivaTech Oncology Inc.	KXK	Class II	2019-09-20
K190856	SeeFactorCT3	Epica International, Inc.	OAS	Class II	2019-09-20
K190001	Supercath 5	Togo Medikit Co., Ltd.	FOZ	Class II	2019-09-20
K181428	Clyra Wound Irrigation Solution	Clyra Medical Technologies, Inc.	FRO	Unclassified	2019-09-20
K180523	INTAI Surgery Navigation System	Intai Technology Corp.	OLO	Class II	2019-09-20
K192344	Sapphire NC Plus Coronary Dilatation Catheter	Orbusneich Medical Trading, Inc.	LOX	Class II	2019-09-19
K192326	HardyDisk AST Lefamulin 20µg (LMU20)	Hardy Diagnostics	JTN	Class II	2019-09-19
K192252	ProPerformance Recovery System	Menlo Brands	IRP	Class II	2019-09-19
K192030	RS80 EVO Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-09-19
K191112	GEHC DXA Bone Densitometers with enCORE version 18	GE Healthcare	KGI	Class II	2019-09-19
K190526	High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws	CarboFix Orthopedics Inc.	PML	Class II	2019-09-19