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 504 of 3529

510(k) clearances, page 504 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K181322	MAGNETOM Sola	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-10-05
K180919	GORE Tri-Lumen Catheter	W. L. Gore & Associates, Inc.	DQY	Class II	2018-10-05
K180054	Royal Flush Plus High-Flow Catheter	Cook Incorporated	DQO	Class II	2018-10-05
K173945	Straumann SC Variobase Abutments	Straumann USA, LLC	NHA	Class II	2018-10-05
DEN180026	Bose Hearing Aid	Bose Corporation	QDD	Class II	2018-10-05
K182533	PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels	PixxGen Corporation	MQB	Class II	2018-10-04
K182436	POWEREASE System	Medtronic Sofamor Danek USA Inc	HBE	Class II	2018-10-04
K182423	Maglumi 2000 Ft4	Shenzhen New Industries Biomedical Engineering Co.,Ltd	CEC	Class II	2018-10-04
K182337	HYBRID Guidewire	Balt USA, LLC	MOF	Class II	2018-10-04
K182189	Encompass SRS Headframe ; Encompass MR SRS Headframe	Qfix	IYE	Class II	2018-10-04
K182122	Ureteric Catheters	MEDLINE INDUSTRIES, LP - Northfield	EYB	Class II	2018-10-04
K182059	Prase MIS Spinal System	Gbs Commonwealth Co., Ltd.	NKB	Class II	2018-10-04
K181949	SYMPHONY™ OCT System	Medos International SARL	NKG	Class II	2018-10-04
K181240	Rhino-Laryngo Fiberscope Olympus ENF-GP2	Olympus Medical Systems Corp.	EOB	Class II	2018-10-04
K180736	WishBone Medical Plate and Screw System	Wishbone Medical, Inc.	HRS	Class II	2018-10-04
K180209	Diazyme 1,5-AG Assay	Diazyme Laboratories, Inc.	NOZ	Class II	2018-10-04
K173076	CURA 16; ScintCare CT16	Fmi Medical Systems, Inc.	JAK	Class II	2018-10-04
K182539	2MP Color LCD Monitor CL-R211	JVCKENWOOD Corporation	PGY	Class II	2018-10-03
K182115	Vinyl Patient Examination Gloves	Pingan Medical Products Co., Ltd.	LYZ	Class I	2018-10-03
K182050	Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch	Siemens Medical Solutions USA, Inc.	IYE	Class II	2018-10-03
K181903	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device	Varian Medical Systems, Inc.	JAQ	Class II	2018-10-03
K181883	FIREFLY® Midline Navigation Guide	Mighty Oak Medical	PQC	Class II	2018-10-03
K181881	Outlet Sacroiliac Joint Fusion System	Sij Surgical	OUR	Class II	2018-10-03
K181527	On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2018-10-03
K181371	uMR 790	Shanghai United Imaging Healthcare Co., Ltd.	LNH	Class II	2018-10-03
K181370	uMR 780	Shanghai United Imaging Healthcare Co., Ltd.	LNH	Class II	2018-10-03
K181196	Caretaker Remote Display App and Caretaker Software Library	Caretaker Medical	DRG	Class II	2018-10-03
K181138	IS-III active System	Neobiotech Co., Ltd.	DZE	Class II	2018-10-03
K180972	ARIX Clavicle System	Jeil Medical Corporation	HRS	Class II	2018-10-03
K182051	FUJIFILM Duodenoscope Model	FUJIFILM Corporation	FDT	Class II	2018-10-02
K181885	Voyant System	Viseon, Inc.	HRX	Class II	2018-10-02
K181867	Deka Smartxide2 Trio	El.en. Electronic Engineering SpA	GEX	Class II	2018-10-02
K181081	Infrared Ear Thermometer	Joytech Healthcare Co., Ltd.	FLL	Class II	2018-10-02
K173642	Klockner Surgical Box	Soadco, S.L.	KCT	Class II	2018-10-02
K171696	NOxBOXi Nitric Oxide Delivery System	Praxair Distribution, Inc.	MRN	Class II	2018-10-02
K181622	StrataMR guider tool	Medtronic Neurosurgery	JXG	Class II	2018-10-01
K181445	AMSure Hydrophilic Intermittent Catheter	Amsino International, Inc.	EZD	Class II	2018-10-01
K173716	MPS2 Myocardial Protection System Console	Quest Medical, Inc	DTR	Class II	2018-10-01
K182415	Alphenix, INFX-8000F/B, V8.0	Canon Medical Systems Corporation	OWB	Class II	2018-09-28
K182376	Harmony	Topcon Healthcare, Inc.	NFJ	Class II	2018-09-28
K182039	Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay	Arthrex GmbH	PHX	Class II	2018-09-28
K181794	Truliant Porous Femoral Components	Exactech, Inc.	MBH	Class II	2018-09-28
K181771	RightEye Vision System	Righteye, LLC	GWN	Class II	2018-09-28
K181746	MICRORAPTOR Knotless Suture Anchor	Smith & Nephew, Inc.	MAI	Class II	2018-09-28
K181652	Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture	Ethicon, Inc	GAM	Class II	2018-09-28
K181476	Prime&Bond active Universal Adhesive	Dentsply Sirona Inc	KLE	Class II	2018-09-28
K181277	E-Cube 12	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2018-09-28
K181124	Acessa ProVu System	Acessa Health, Inc.	HFG	Class II	2018-09-28
K181088	TSP Crosser Transseptal Access System	Transseptal Solutions, Ltd.	DYB	Class II	2018-09-28
K180998	BioHorizons CAD/CAM Bars	BioHorizons Implant Systems Inc	NHA	Class II	2018-09-28