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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 669 of 3530

510(k) clearances, page 669 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K153487	CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	LJS	Class II	2016-02-04
K153141	DyeVert Contrast Modulation System	Osprey Medical, Inc.	DXT	Class II	2016-02-04
K153082	Rampart A Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2016-02-04
K152948	Medline Anti-Fog Solution	MEDLINE INDUSTRIES, LP - Northfield	OCT	Class II	2016-02-04
K152587	DermaScalp Laser Cap	Dermascalp, LLC	OAP	Class II	2016-02-04
K152529	NaturaLase CO2 Laser System	Focus Medical, LLC.	GEX	Class II	2016-02-04
K152489	ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray	Panoramic Corp.	OAS	Class II	2016-02-04
K152237	The Entasis Dual-Lead Sacroiliac Implant	Corelink, LLC	OUR	Class II	2016-02-04
K152127	CorMatrix Tyke	Cormatrix Cardiovascular, Inc.	DXZ	Class II	2016-02-04
K151274	Dr's Finder	Good Doctors Co., Ltd.	LQY	Unclassified	2016-02-04
K160108	Synapse PACS	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2016-02-03
K153398	Comprehensive SRS/Nexel Elbow	Biomet Manufacturing Corp	JDC	Class II	2016-02-03
K153203	Navigation Instruments	Globus Medical, Inc.	OLO	Class II	2016-02-03
K152994	Adaptivo	Aurora Technology Development, LLC	IYE	Class II	2016-02-03
K152878	SUNTEC Mechanical Wheelchair, model ST-WL-1000	Danyang Suntec Auto Parts Co., Ltd.	IOR	Class I	2016-02-03
K151912	AIR-FLOW handy 3.0 PLUS	E.M.S. - Electro Medical Systems SA	EFB	Class I	2016-02-03
K160014	iHealth Track Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2016-02-02
K153529	WS80A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2016-02-02
K153416	ArcScan Insight 100	Arcscan, Inc.	IYO	Class II	2016-02-02
K153211	M-Fix Acromioclavicular Device	Coracoid Solutions, Inc.	HTN	Class II	2016-02-02
K153059	HF1202H PowerPlus Portable X-ray Equipment	Minxray Inc	IZL	Class II	2016-02-02
K152410	Top Fine Pen Needle	Medexel Co., Ltd.	FMI	Class II	2016-02-02
K160044	Image1 SPIES System	Karl Storz Endoscopy-America, Inc.	FET	Class II	2016-02-01
K153528	PacEndo EDTA	Pac-Dent International, Inc.	KJJ	Unclassified	2016-02-01
K153304	Hansen Medical Magellan Robotic Catheter eKit	Hansen Medical, Inc.	DRA	Class II	2016-02-01
K153204	In2Bones Kirschner wire	In2Bones SAS	HTY	Class II	2016-02-01
K152505	C2 NerveMonitor System	Inomed Medizintechnik GmbH	ETN	Class II	2016-02-01
K152324	YAHUA Spinal System	Beijing Weigao Yahua Artificial Joint Development Co., Ltd.	MNI	Class II	2016-02-01
K151036	Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments	Medtronic, Inc.	GCJ	Class II	2016-02-01
K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	Diazyme Laboratories, Inc.	GIS	Class II	2016-01-31
K153628	ROSC-U Mini Chest Compressor (RMCC)	Resuscitation International	DRM	Class II	2016-01-30
K153475	SD5 & SD6 Ultrasonic Tabletop Doppler	Edan Instruments, Inc.	KNG	Class II	2016-01-29
K153428	Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System	Orthofix SRL	NKB	Class II	2016-01-29
K153169	PASS OCT Patient Specific Rods	Medicrea International	NKG	Class II	2016-01-29
K153157	Sonendo Gentle Wave System	Sonendo Inc	ELC	Class II	2016-01-29
K152915	Eye-Sync	Syncthink, Inc.	GWN	Class II	2016-01-29
K152247	ATLANTIS Crown	Dentsply International, Inc.	EIH	Class II	2016-01-29
K151939	COALITION Spacers	Globus Medical, Inc.	OVE	Class II	2016-01-29
K151735	TriMed Humeral Supracondylar Fixation System	Trimed Inc	HRS	Class II	2016-01-29
K151426	ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+	Scandidos, Inc.	IYE	Class II	2016-01-29
K151194	Klockner Dental Implant Abutments (II)	Soadco, S.L.	NHA	Class II	2016-01-29
K150893	IntelliCuff	Hamilton Medical AG	BSK	Class II	2016-01-29
K142664	URight Hemoglobin A1c system, FORA A1c System	Taidoc Technology Corporation	LCP	Class II	2016-01-29
K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	Radiometer America, Inc	JJY	Class I	2016-01-28
K153686	SPIWay Endonasal Access Guide	SPIWay, LLC	LYA	Class I	2016-01-28
K153525	Seneka II Polyscrew Pedicle Fixation System	Senecka Spine	NKB	Class II	2016-01-28
K153459	Tacvac	Athena GTX	BTA	Class II	2016-01-28
K153423	CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	LJS	Class II	2016-01-28
K153186	Adjustable Fixation Device	ArthroCare Corporation	MBI	Class II	2016-01-28
K153129	dynaMX Tabbed Staple	Mx Orthopedics, Corp.	JDR	Class II	2016-01-28