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 371 of 3528

510(k) clearances, page 371 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201873	Sparrow Therapy System	Spark Biomedical Inc.	PZR	Class II	2021-01-02
K202706	Surgical Gown (Sterile), Surgical Gown (Non-sterile)	B.j.zh.f.panther Medical Equipment Co.,Ltd	FYA	Class II	2020-12-31
K202681	Promisemed Covered Safety Pen Needle	Promisemed Hangzhou Meditech Co.,Ltd.	FMI	Class II	2020-12-31
K202615	Nordiwell Medical Face Mask	Changzhou Combat Protective Equipment Co., Ltd.	FXX	Class II	2020-12-31
K202322	Sim&Size	Sim&cure	PZO	Class II	2020-12-31
K202267	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles	Isoray Medical, Inc.	KXK	Class II	2020-12-31
K201342	HANAROSTENT Trachea/Bronchium (CCC)	M.I.Tech Co Ltd	JCT	Class II	2020-12-31
K201239	NuEra Tight Family, EMS Model	Bios S.r.l.	NGX	Class II	2020-12-31
K203239	Arthrex Low Profile Screws	Arthrex GmbH	HWC	Class II	2020-12-30
K203166	PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U	PENTAX of America, Inc.	ODG	Class II	2020-12-30
K202690	Remunity Pump for Remodulin (treprostinil) Injection	Deka Research & Development Corp.	QJY	Class II	2020-12-30
K202372	Upper Arm Electronic Blood Pressure Monitor	Conmo Electronic Company Limited	DXN	Class II	2020-12-30
K202268	CrossRoads Tray System	Crossroads Extremity Systems LLC	KCT	Class II	2020-12-30
K202038	CryoTreQ	Vitreq BV	HPS	Class II	2020-12-30
K201776	Foley Balloon Catheter for Urology	Apollon Co., Ltd.	EZL	Class II	2020-12-30
K201754	JianYu Surgical Mask	Jiangsu JianYu Health Medical Co., Ltd	FXX	Class II	2020-12-30
K193159	NeuroAmp II, NeuroAmp II.5s	Corscience GmbH & Co. KG	GWQ	Class II	2020-12-30
K203511	Baby Gorilla/Gorilla Plating System	Paragon 28	HRS	Class II	2020-12-29
K203508	BriefCase	Aidoc Medical Ltd.	QAS	Class II	2020-12-29
K203219	Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever	Stryker Corp.	POL	Class II	2020-12-29
K203137	Venue Fit	GE Healthcare	IYN	Class II	2020-12-29
K202940	First Relief v1	Dyansys, Inc.	QHH	Class II	2020-12-29
K202699	E-Cath STIM acc. Tsui	Pajunk GmbH Medizintechnologie	CAZ	Class II	2020-12-29
K202456	M5 Recorder	Global Instrumentation Corp.	DSH	Class II	2020-12-29
K202455	Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems	Supersonic Imagine	IYN	Class II	2020-12-29
K200965	Xr-Mx/1000	Karl Storz Endoscopy-America, Inc.	JAA	Class II	2020-12-29
K203062	Optiflux Series of Dialyzers F160NR, F180NR, F200NR	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2020-12-28
K202730	Quadra-P	Medacta International SA	LZO	Class II	2020-12-28
K202454	Smart SPACE Shoulder System	Techmah Medical, LLC	QHE	Class II	2020-12-28
K202248	Attune Revision Sleeve LPS Femoral Adaptors	Depuy Ireland UC	JWH	Class II	2020-12-28
K201800	Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)	Nanoray Co., Ltd.	EHD	Class II	2020-12-28
K201781	Uni-FuZe-P Bone Putty	Zavation Medical Products, LLC	MQV	Class II	2020-12-28
K200970	Self-Contained Biological Indicator	True Indicating LLC	FRC	Class II	2020-12-28
K200968	Abc33l, Abc35l, Abc37l, Abc39l, Abc33r, Abc35r, Abc37r, Abc39r	Insung Medical Co., Ltd.	CBI	Class II	2020-12-28
K200458	Tailored-C Cervical Interbody Fusion System	Bespoke Technologies	ODP	Class II	2020-12-28
K200321	Novaerus NV1050	Novaerus US Inc.	FRF	Class II	2020-12-28
K201747	8-CH Electroencephalography Amplifier	Hipposcreen Neurotech Corp.	GWL	Class II	2020-12-27
K193419	MBT Sepsityper	Bruker Daltonik GmbH	QNJ	Class II	2020-12-27
K202485	ImPACT Version 4	Impact Applications, Inc.	POM	Class II	2020-12-25
K203544	UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories	Lumenis Ltd	GEX	Class II	2020-12-24
K200426	Acute Dual Lumen Hemodialysis Catheter	Health Line International Corporation	MPB	Class II	2020-12-24
K200422	Image Quality Analyzer (IQA)	Visionquest Biomedical, Inc.	NFJ	Class II	2020-12-24
K203540	Bridge Occlusion Balloon	Spectranetics Corp.	MJN	Class II	2020-12-23
K203467	WishBone Medical Plate and Screw System	Wishbone Medical, Inc.	HWC	Class II	2020-12-23
K203257	LUBi Water Based Personal Lubricant	Boya Biotechnology Company Limited	NUC	Class II	2020-12-23
K203207	Omnia Medical TiBrid-SA	Omnia Medical	OVD	Class II	2020-12-23
K203026	AltiVate® Anatomic Pegged Glenoid with Markers	Encore Medical, LP	KWS	Class II	2020-12-23
K202882	Affinity	Hermes Medical Solutions AB	KPS	Class II	2020-12-23
K202637	F3D Corpectomy System	Corelink, LLC	MQP	Class II	2020-12-23
K202526	OmniTom Elite	Neurologica Corporation, A Subsidiary of Samsung Electronics	JAK	Class II	2020-12-23