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 2026-10-21, 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 535 of 3529

510(k) clearances, page 535 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K180517	CorPath GRX System	Corindus, Inc.	DXX	Class II	2018-03-29
K173799	NaviCross 0.018	Terumo Corp.	DQY	Class II	2018-03-29
K173533	Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter	Poiesis Medical, LLC	EZL	Class II	2018-03-29
K173439	Bloom2 Programmable Electrophysiology Stimulator	Fischer Medical	JOQ	Class II	2018-03-29
K173082	Arco™-SA Lumbar Cage System	Neurostructures, Inc.	OVD	Class II	2018-03-29
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer GmbH	JWH	Class II	2018-03-29
K172843	TwitchView System	Blink Device Company	KOI	Class II	2018-03-29
K172322	Atellica IM Total hCG (ThCG)	Siemens Healthcare Diagnostics Inc.	JHI	Class II	2018-03-29
K172298	Olympus Urf-P6/p6r	Olympus Medical Systems Corp.	FGB	Class II	2018-03-29
K172071	Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2018-03-29
K171841	Arthrex Shoulder System	Arthrex GmbH	KWS	Class II	2018-03-29
K171624	IXOS Radius Plate System	Stuckenbrock Medizintechnik GmbH	HRS	Class II	2018-03-29
K180558	PressureWire X	St. Jude Medical (Now Part of Abbott Medical)	DXO	Class II	2018-03-28
K180504	Mission Lipid Panel Monitoring System	Acon Laboratories, Inc.	CHH	Class I	2018-03-28
K180056	Genesys Spine AIS-C Cervical Anchored Interbody System	Genesys Spine	OVE	Class II	2018-03-28
K173727	Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor	Ambu A/S	EOQ	Class II	2018-03-28
K173591	Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas	Spectrum Medical Inc	DRY	Class II	2018-03-28
K173489	GYN-Pump PH304	Novanta Medical GmbH	HIG	Class II	2018-03-28
K173465	Concentrix MX-AC High-Speed Handpiece	Dentalez, Inc.	EFB	Class I	2018-03-28
K172627	David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette	Runbio Biotech Co.,Ltd	LCX	Class II	2018-03-28
K172444	ROSA BRAIN (v3.0.0.5)	MedTech LLC	HAW	Class II	2018-03-28
K172235	CoreHip® System	Aesculap Implants Systems, LLC	LZO	Class II	2018-03-28
K171969	Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket	Wilson-Cook Medical Inc.	LQR	Class II	2018-03-28
K180537	Zavation Buttress Plate System	Zavation Medical Products, LLC	KWQ	Class II	2018-03-27
K180319	Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution	Bausch & Lomb Incorporated	MRC	Class II	2018-03-27
K180308	Prelude	Medcom GmbH	MUJ	Class II	2018-03-27
K180114	AEON Retrieval Bag	Lexington Medical, Inc.	GCJ	Class II	2018-03-27
K180063	OCM-G1 Attachment	The Anspach Effort, Inc.	ERL	Class II	2018-03-27
K173660	LenSx Laser System	Alcon Laboratories	OOE	Class II	2018-03-27
K173214	NES Reprocessed RF Stylet (RFS)	Northeast Scientific, Inc. (Nes)	NUJ	Class II	2018-03-27
K172269	FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System	Globus Medical, Inc.	PML	Class II	2018-03-27
K171966	Mpact® 3D Metal™ Implants and Augments 3D Metal™	Medacta International SA	LPH	Class II	2018-03-27
K171241	Pulse Oximeter	Hunan Accurate Bio-Medical Technology Co., Ltd.	DQA	Class II	2018-03-27
K170605	Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	DXN	Class II	2018-03-27
DEN170088	Dexcom G6 Continuous Glucose Monitoring System	Dexcom, Inc.	QBJ	Class II	2018-03-27
K180315	Diskom	Biopsybell S.r.l.	HRX	Class II	2018-03-26
K180149	Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide	Medtronic, Inc.	LFL	Unclassified	2018-03-26
K173922	C-PTFETM Surgical Suture	Cp Medical	NBY	Class II	2018-03-26
K173310	SmartTouch	Adherium (Nz), Ltd.	CAF	Class II	2018-03-26
K172760	REST EAZY Appliance	Insert Molding Solutions, Inc.	LRK	Class II	2018-03-26
K172354	OssBuilder System	OSSTEM Implant Co., Ltd.	JEY	Class II	2018-03-26
K172017	Black Silicone Filiform Double Pigtail Stent Set	Cook Incorporated	FAD	Class II	2018-03-26
DEN170023	ThermoNeuroModulation Device, TNM Device	Scion Neurostim, LLC	QAR	Class II	2018-03-26
K172035	EKOS ultrasound EVD Device, EVD Control Unit	Btg International, Inc.	JXG	Class II	2018-03-24
K180473	ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR	ECOTRON Co., Ltd.	OWB	Class II	2018-03-23
K180052	UriSwab-Urine Collection, Transport and Preservation System	Copan Italia	JSM	Class I	2018-03-23
K173886	CPRmeter 2 CPR Feedback Device	Laerdal Medical a/S	LIX	Class II	2018-03-23
K173425	Srt-100+	Sensus Healthcare	JAD	Class II	2018-03-23
K173241	Med-Tab	Plum Medical Solutions GmbH	LLZ	Class II	2018-03-23
K172723	Dario LC Blood Glucose Monitoring System	Labstyle Innovation, Ltd.	NBW	Class II	2018-03-23