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 2026-10-19, 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 501 of 3529

510(k) clearances, page 501 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech	Bard Access Systems, Inc.	IYO	Class II	2018-10-24
K182140	da Vinci Xi Surgical System, da Vinci X Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2018-10-24
K181596	Spine Wave Navigated Instruments	Spine Wave Inc	OLO	Class II	2018-10-24
K181560	Cios Alpha	Siemens Medical Systems USA, Inc.	OWB	Class II	2018-10-24
K181530	World Total Knee System	Signature Orthopaedics Pty Limited	JWH	Class II	2018-10-24
K180940	KODEX EPD System	Philips Medical Systems Nederland B.V.	DQK	Class II	2018-10-24
K180788	Gas Module 3	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BZK	Class II	2018-10-24
K180758	Osteocera Resorbable Bone Substitute	Wiltrom Corporation Limited	MQV	Class II	2018-10-24
K180605	GastroFlush	Bionix Development Corp.	KNT	Class II	2018-10-24
K180302	Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter	Cook Incorporated	MQF	Class II	2018-10-24
K180275	VAMP Optima closed blood sampling system	Edwards Lifesciences LLC	KRA	Class II	2018-10-24
K173756	Certus 140 2.45GHz Ablation System	Neuwave Medical, Inc.	NEY	Class II	2018-10-24
K173603	Monarch Airway Clearance System	Hill-Rom Holdings, Inc.	BYI	Class II	2018-10-24
DEN180004	picoAMH ELISA	Ansh Labs, LLC	QDH	Class II	2018-10-24
K182622	Gu60a, Gu60a-65	Samsung Electronics Co., Ltd.	KPR	Class II	2018-10-23
K182529	Xperius Ultrasound System	Philips North America LLC	IYN	Class II	2018-10-23
K182283	FUSE Pedicle Screw System	Black Box Medical	NKB	Class II	2018-10-23
K182106	Btl 799-2T	BTL Industries, Inc	NGX	Class II	2018-10-23
K182042	Randox Calcium (Ca)	Randox Laboratories, Limited	CJY	Class II	2018-10-23
K182002	Cumulus Remover	Kitazato Corporation	MQL	Class II	2018-10-23
K181964	JiveX	Visus Health IT GmbH	LLZ	Class II	2018-10-23
K180622	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	Medtronic, Inc.	KNT	Class II	2018-10-23
K180046	Masimo Rad-97 and Accessories	Masimo Corporation	DQA	Class II	2018-10-23
K173824	Humeral Short Stem System	SHOULDER INNOVATIONS, Inc	MBF	Class II	2018-10-23
K172670	BD Single Use, Hypodermic Syringe	Becton Dickinson & Co	FMF	Class II	2018-10-23
K181922	Sonendo Material A	Sonendo Inc	KIF	Class II	2018-10-22
K181566	Nutrifill	Contamac Ltd.	MRC	Class II	2018-10-22
K181254	Quadra P	Medacta International SA	LZO	Class II	2018-10-22
K181248	Comarch e-Care Platform	Comarch Healthcare SA	DRG	Class II	2018-10-22
K181192	PIP Fix	Hand Biomechanics Lab Inc	JEC	Class II	2018-10-22
K180554	ANTHEM Fracture System	Globus Medical, Inc.	HRS	Class II	2018-10-22
K172733	TD-1035 Thermometer	Taidoc Technology Corporation	FLL	Class II	2018-10-22
K172533	GM Implant Tubes, Length Cutting Gauge	Varian Medical Systems, Inc.	JAQ	Class II	2018-10-22
K181223	ImPACT	Impact Applications, Inc.	POM	Class II	2018-10-20
K182735	Paragonix SherpaPak Cardiac Transport System	Paragonix Technologies Inc.	MSB	Class II	2018-10-19
K182644	EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2	Abbott Medical	DQK	Class II	2018-10-19
K182590	1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA	GE Healthcare	MOS	Class II	2018-10-19
K182586	DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port	Medtronic, Inc.	DWF	Class II	2018-10-19
K182561	UroNav (Version 3.0)	Invivo Corporation	LLZ	Class II	2018-10-19
K182450	Vivid S60N, Vivid S70N	GE Healthcare	IYN	Class II	2018-10-19
K182282	Vantage Orian 1.5T, MRT-1550, V4.5	Canon Medical Systems Corporation	LNH	Class II	2018-10-19
K182264	ICONN Revolution Knotless Suture Anchor	Iconn Orthopedics, LLC	MBI	Class II	2018-10-19
K181621	Stable-C Interbody System	Nexus Spine, L.L.C.	OVE	Class II	2018-10-19
K181433	MAGNETOM Vida	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-10-19
K180516	EchoS	Echolight S.p.A.	MUA	Class II	2018-10-19
K180213	Titanium TomoFix Medial High Tibia Plate Anatomical	Synthes (USA) Products LLC	HRS	Class II	2018-10-19
K180205	AVELLE Negative Pressure Wound Therapy System	ConvaTec Limited	OMP	Class II	2018-10-19
K180202	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	IMMUNO CONCEPTS, NA, Ltd.	DBL	Class II	2018-10-19
K173594	Straumann cerabone	Straumann USA, LLC	NPM	Class II	2018-10-19
K182591	RadiForce RX360, RX360-AR	Eizo Corporation	PGY	Class II	2018-10-18