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 528 of 3529

510(k) clearances, page 528 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171690	Trident Extremity Fixation System	Trident Orthopedics	HRS	Class II	2018-05-08
K180296	Afinion HbA1c Dx	Alere Technologies AS	PDJ	Class II	2018-05-07
K180079	Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation	Hill-Rom Inc.	BZQ	Class II	2018-05-07
K180034	Weinmann Tracheostomy Exchange Set	Cook Incorporated	JOH	Class II	2018-05-07
K180031	Endopath Electrosurgery Probe Plus II	Ethicon Endo-Surgery Inc	GEI	Class II	2018-05-07
DEN170015	Hemospray Endoscopic Hemostat	Wilson-Cook Medical Inc.	QAU	Class II	2018-05-07
K180891	EVOL Spinal Interbody System, EVOS Lumbar Interbody System	Cutting Edge Spine	MAX	Class II	2018-05-04
K180740	VitriGuard	CooperSurgical, Inc.	MQK	Class II	2018-05-04
K180641	Invenia ABUS Viewer	GE Healthcare	LLZ	Class II	2018-05-04
K180623	Ulthera System	Merz North America, Inc.	OHV	Class II	2018-05-04
K180437	Hexanium® TLIF	Spinevision SAS	MAX	Class II	2018-05-04
K180317	EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System	Microport Orthopedics Inc.	MBH	Class II	2018-05-04
K180313	Apollo TMS Therapy System	Mag & More GmbH	OBP	Class II	2018-05-04
K180157	Qt ECG	QT Medical, Inc	DXH	Class II	2018-05-04
K173913	MEDRAD® Imaging Bulk Package Transfer Set	Bayer U.S., LLC	PQH	Class II	2018-05-04
K173892	NuVasive® XLX Interbody System	Nu Vasive, Incorporated	MAX	Class II	2018-05-04
K173874	StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO	ORIGAMI SURGICAL Inc.	GAM	Class II	2018-05-04
K173711	Wallaby Avenir Coil System	Wallaby Medical	HCG	Class II	2018-05-04
K173684	g.Estim PRO	G.tec Medical Engineering GmbH	GYC	Class II	2018-05-04
K173345	TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System	Taidoc Technology Corporation	JIN	Class I	2018-05-04
K172614	Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left	Caldera Medical, Inc.	PWJ	Class II	2018-05-04
K172568	Cervage	Precifit Medical, Ltd.	ODP	Class II	2018-05-04
K172271	Trackit T4 EEG Amplifier	Lifelines Ltd.	GWQ	Class II	2018-05-04
K172100	URIS OMNI System	TruAbutment Inc.	DZE	Class II	2018-05-04
K162021	3.0 Dynamic TiBase	Talladium Espana, SL	NHA	Class II	2018-05-04
K181001	Medtronic Confida Brecker Guidewire	Medtronic Core Valve, LLC	DQX	Class II	2018-05-03
K180939	Indigo Aspiration System - Modified 110 Aspiration Tubing	Penumbra Inc.	QEW	Class II	2018-05-03
K180214	Repris Bladder Injection System	Uro-1, Inc.	FBK	Class II	2018-05-03
K180162	VivaScope System	Caliber Imaging & Diagnostics, Inc.	PSN	Class II	2018-05-03
K180071	STYLO Interbody Fusion Device	Legend Spine Technologies	MAX	Class II	2018-05-03
K180019	CAAS Workstation	PIE Medical Imaging B.V.	IZI	Class II	2018-05-03
K173540	Brainsway Deep (DTMS) System	Brainsway Ltd.	OBP	Class II	2018-05-03
K172980	Micropuncture Pedal Access Set	Cook Incorporated	DYB	Class II	2018-05-03
K172777	Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7	Pajunk GmbH Medizintechnologie	BSO	Class II	2018-05-03
K172137	Piezotome Cube	Satelec-Acteon Group	DZI	Class II	2018-05-03
K171577	Smartcord, Smartcord X	Eastdent Co Ltd	MVL	Unclassified	2018-05-03
K171007	Fluorescence Mode	Carl Zeiss Suzhou Co., Ltd.	NBL	Class II	2018-05-03
K180796	Spineology Navigation Instruments	Spineology, Inc.	OLO	Class II	2018-05-02
K180599	Venue	GE Healthcare	IYN	Class II	2018-05-02
K180352	7D Surgical System	7D Surgical, Inc.	OLO	Class II	2018-05-02
K180264	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	Gold Standard Diagnostics, LLC	LSR	Class II	2018-05-02
K180028	Cook 810 Set, Desilets-Hoffman Introducer Set	Cook Incorporated	EZN	Class II	2018-05-02
K173946	ADAPT for Gamma3	Stryker Corp.	OLO	Class II	2018-05-02
K173861	Drug Relief	Dyansys, Inc.	PZR	Class II	2018-05-02
K173825	MC 300R* Nebulizer	Trudell Medical International	CAF	Class II	2018-05-02
K173807	Accu O2 Oxygen Analyzer	Precision Medical, Inc.	CCL	Class II	2018-05-02
K173653	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit	Alere Scarborough, Inc.	PGX	Class II	2018-05-02
K172864	Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	Maxter Glove Manufacturing Sdn Bhd	LZC	Class I	2018-05-02
K172409	Lite	Tzora Active Systems, Ltd.	INI	Class II	2018-05-02
K180848	AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches	ArthroCare Corporation	GEI	Class II	2018-05-01