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 2026-10-29, 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 853 of 3530

510(k) clearances, page 853 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123254	Ultrasound Scanner Flex Focus	BK Medical ApS	IYN	Class II	2013-02-13
K123097	Dose Tracking System Model Xidf-Dts801	Toshiba America Medical Systems, In.C	JAA	Class II	2013-02-13
K121826	Integra Proximal Humeral Plate System	Ascension Orthopedics, Inc.	HRS	Class II	2013-02-13
K120236	Transferrin Kit for Use on the Spaplus	The Binding Site Group Ltd.	DDG	Class II	2013-02-13
K130209	Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow Fiber Oxygenator with Integrated	Corcym Inc.	DTZ	Class II	2013-02-12
K130090	Sta Compact Max	Diagnostica Stago, Incorporated	JPA	Class II	2013-02-12
K130043	Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System	Teleflexmedical, Inc.	CAC	Class II	2013-02-12
K123938	Syngo Mr B19 for Magnetom Avanto, Syngo Mr B19 for Magnetom Espree, Syngo Mr B19 for Magnetom Symphony a Tim System, Syn	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-02-12
K123705	Trinity Non-Occluded Titanium Plasma Sprayed (Tps) Acetabular Shells	Corin USA	LZO	Class II	2013-02-12
K123544	Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter	Medtronic, Inc.	LIT	Class II	2013-02-12
K122925	New Stetic Artificial Teeth	New Stetic	ELM	Class II	2013-02-12
K121877	Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates	Exactech, Inc.	KWP	Class II	2013-02-12
K120663	Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi	Agilent Technologies, Inc.	MYA	Class II	2013-02-12
K113614	Accu-Check Compact Plus Blood Glucose Monitoring System	Roche Diagnostics GmbH	NBW	Class II	2013-02-12
K113236	Foryou Npwt Device	Foryou Medical Electronics Co, Ltd.	OMP	Class II	2013-02-12
K130132	Babylance Heel Incision Device	Medipurpose Pte. Ltd.	FMK	Class II	2013-02-11
K123620	Filmarray Respiratory Panel (Rp)	BioFire Diagnostics, LLC	OCC	Class II	2013-02-11
K123494	Solea	Convergent Dental	GEX	Class II	2013-02-11
K123450	Phonak Tinnitus Balance	Phonak, Inc.	KLW	Class II	2013-02-11
K123435	Ipl Therapy System	Beijing Sincoheren S&T Development Co, Ltd.	ONF	Class II	2013-02-11
K123116	Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)	Worldmed Manufacturing Sdn. Bhd.	LZA	Class I	2013-02-11
K122411	J-Scope System	Myelotec, Inc.	HRX	Class II	2013-02-11
K121069	3M Vflex Health Care Particulate Respirator and Surgical Mask	3M Company	MSH	Class II	2013-02-11
K102751	Labonacheck Gluppy Blood Glucose Monitoring System	Ceragem Medisys, Inc.	NBW	Class II	2013-02-11
K130103	Coronis Fusion 6Mp	Barco N.V.	LLZ	Class II	2013-02-08
K130070	4Mp Color Lcd Monitor, Radiforce Rx440	Eizo Nanao Corporation	LLZ	Class II	2013-02-08
K123799	Psychemedics Microplate Eia for Oxycodone in Hair	Psychemedics Corp.	DJG	Class II	2013-02-08
K123688	Profemur Tl Classic Hip Stem	Wrightmedicaltechnologyinc	LZO	Class II	2013-02-08
K123596	Optima Ct520	GE Hangwei Medical Systems, Co. Ltd	JAK	Class II	2013-02-08
K123488	Linshi Nitrile Disposable Exam Gloves, Powder-Free	Puyang Linshi Health Co., Ltd.	LZA	Class I	2013-02-08
K123308	Pulstar Logix Intermittent Pneumatic Compression System	Albahealth, LLC	JOW	Class II	2013-02-08
K123249	Diagnostic Ultrasound System	Edan Instruments, Inc.	IYN	Class II	2013-02-08
K123131	St Aia-Pack 25-Oh Vitamin D, St Aia-Pack 25-Oh Vitamin D Calibrator Set, Aia-Pack 25-Oh Vitamin D Control Set, and St Ai	Tosoh Bioscience Inc	MRG	Class II	2013-02-08
K123023	Surgery Rehearsal Platform	Surgical Theater Inc	LLZ	Class II	2013-02-08
K122810	Compact Digital Blood Pressure Monitor	Thermor Ltd.	DXN	Class II	2013-02-08
K122386	Victus Femtosecond Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2013-02-08
K122065	Digital Impression System for Orthodontic Use	Ormco Corp.	NOF	Class II	2013-02-08
K121942	Adenovirus R-Gene US	Argene SA	OCC	Class II	2013-02-08
K121565	Uni-Gold Cryptosporidium	Trinity Biotech, PLC	MHJ	Class II	2013-02-08
K121280	Myosure Intrument Tray	Hologic, Inc.	KCT	Class II	2013-02-08
K113268	Alexis O Wound Protector/retractor	Applied Medical Resources Corp	KGW	Class II	2013-02-08
K112616	Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis	Heinz Kurz GmbH Medizintechnik	ETB	Class II	2013-02-08
K130057	Espin	Nlt Spine, Ltd.	HRX	Class II	2013-02-07
K123969	Xiphos	Difusion Technologies	MAX	Class II	2013-02-07
K123521	Reliance Spinal Screw System	Reliance Medical Systems, LLC	MNI	Class II	2013-02-07
K123232	Spineology Spinous Process Plate	Spineology, Inc.	KWP	Class II	2013-02-07
K123216	Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand, Including 4-Wheeled Stand Base an	Aimago SA	DPT	Class II	2013-02-07
K123206	Maxim Surgical X-Treme Interbody Fusion System	Maxim Surgical	ODP	Class II	2013-02-07
K122871	Compressyn Staple	Dallen Medical, Inc.	JDR	Class II	2013-02-07
K122822	Spectrum Spine Laminoplasty Plating System	Spectrum Spine Inc	NQW	Class II	2013-02-07