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 788 of 3530

510(k) clearances, page 788 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131900	Contec Electrocardiograph	Contec Medical System Co., Ltd.	DPS	Class II	2014-03-05
K130751	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Cabin Plastic Co., Ltd.	LYZ	Class I	2014-03-05
K140126	Sonic Window	Analogic Corp.	IYO	Class II	2014-03-04
K140099	Lighthouse Urinary Catheter	Seedings Life Science Ventures, LLC	EZL	Class II	2014-03-04
K133525	Locking Compression Bone Plates and Screw System	Changzhou Dean Medical Instrument Co, Ltd.	HRS	Class II	2014-03-04
K133472	Sauflon Clariti 1 Day with Tint (Toric/multifocal)	Souflon Pharmaceuticals, Ltd.	LPL	Class II	2014-03-04
K133383	Hem-7320	Omron Healthcare Co., Ltd.	DXN	Class II	2014-03-04
K133339	Zimmer Dental Tapered Screw Vent T Implant, Ha Coated;zimmer Dental Tapered Screw-Vent M Implant, Ha Coated	ZimVie US Corp LLC	DZE	Class II	2014-03-04
K133117	Andon Blood Pressure Cuff	Andon Health Co., Ltd	DXQ	Class II	2014-03-04
K133028	Rithm Id Electrophysiology Catheter	Synaptic Medical Corporation	DRF	Class II	2014-03-04
K132936	Novopore Dressing	Polynovo Biomaterials Pty Ltd	OMP	Class II	2014-03-04
K132908	Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit	Medtec LLC	IYE	Class II	2014-03-04
K131788	Healthstats a-Pulse Caspal + and Mc3100+ Monitors and My-Bp Bp Management Application Software	Healthstats International Pte., Ltd.	DXN	Class II	2014-03-04
DEN080009	Airpurge	Anesthesia Safety Products, LLC	OKL	Class II	2014-03-04
K133937	Heartscan Software	Morpheus Imaging, Inc.	LLZ	Class II	2014-03-03
K133668	Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul	Shoulder Options, Inc.	HRS	Class II	2014-03-03
K133547	Nxstage System One with Nxview	NxStage Medical Inc	KDI	Class II	2014-03-03
K132800	Skintell	AGFA Healthcare Corp.	NQQ	Class II	2014-03-03
K131659	Moerae Vein Preparation Kit	Moerae Matrix, Inc.	GBX	Class I	2014-03-03
K131402	Visiclear Smoke Evacuation System	Buffalo Filter Co., Inc.	FYD	Class II	2014-03-03
K130618	Sfi-Anchor	Cendres & Metaux SA	NHA	Class II	2014-03-03
K123193	Ipm Wound Gel Bio	Glycobiosciences, Inc.	FRO	Unclassified	2014-03-03
K140283	Osteomed Extremifuse System	Osteomed	HWC	Class II	2014-02-28
K140227	Monoderm Surgical Suture	Surgical Specialties Corp	GAM	Class II	2014-02-28
K133999	Diamondback 360 Peripheral Orbital Atherectomy System	Cardiovascular Systems Incorporated	MCW	Class II	2014-02-28
K133858	Tensyn Band	Dallen Medical, Inc.	HTN	Class II	2014-02-28
K133715	Charlotte Claw Plate System	Wrightmedicaltechnologyinc	HRS	Class II	2014-02-28
K133702	Presto Breast Biopsy Device	Sontina Medical, LLC	KNW	Class II	2014-02-28
K133671	Iconix All Suture Anchors	Stryker Corp.	MBI	Class II	2014-02-28
K133654	Scenium	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-02-28
K133609	The Dome S6c	NDS Surgical Imaging, LLC	LLZ	Class II	2014-02-28
K133451	Fixos Screw System	Stryker Trauma GmbH	HWC	Class II	2014-02-28
K133158	Nd: Yag Laser System	Beijing Toplaser Technology Co., Ltd.	GEX	Class II	2014-02-28
K133119	Flowtron Acs800 Pump and Tri Pulse Garments	ArjoHuntleigh Polska Sp. zo.o.	JOW	Class II	2014-02-28
K133090	Oxicare Fingertip Pulse Oximeter	Delbio Incorporation	DQA	Class II	2014-02-28
K132810	Gladiator Elite Pta Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2014-02-28
K132763	Advanced Viewer	Brainlab, Inc.	LLZ	Class II	2014-02-28
K132580	Coated Vicryl Plus Antimicrobial (Polyglactin 910) Synthetic Absorbable Suture	Ethicon, Inc	GAM	Class II	2014-02-28
K132469	The Bite Guard	International Profit Builders, Inc.	OBR	Unclassified	2014-02-28
K132064	Biomarc Fiducial Marker	Carbon Medical Technologies, Inc.	IYE	Class II	2014-02-28
K131896	Supervan 1.5T Magnetic Resonance Imaging System	Suzhou Anke Medical System Co., Ltd.	LNH	Class II	2014-02-28
K131777	Hyper Source-Unit Rotating Gamma System	Hyper Technology, Inc.	IWB	Class II	2014-02-28
K131727	Cera-Chek 1070 Blood Glucose Monitoring System	Ceragem Medisys, Inc.	LFR	Class II	2014-02-28
K131605	Elecsys Precicontrol Cmv Igg, Elecsys Cmv Igg Immunoassay	Roche Diagnostics GmbH	LFZ	Class II	2014-02-28
K131548	Synthes Trochanteric Fixation Nail - Advanced System	Synthes (USA) Products LLC	HSB	Class II	2014-02-28
K131334	Herpes Simplex Virus Type 1 Igg Elisa Test	Gold Standard Diagnostics, LLC	MXJ	Class II	2014-02-28
K130982	Lerado, Power Wheelchair	Lerado Global (Macao Commercial Offshore) Limited	ITI	Class II	2014-02-28
K130847	Jintronix Rehabilitation System (Jrs)	Jintronix Inc.	LXJ	Class II	2014-02-28
K130255	Hemoglobin A1c, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls	Abbott Medical	PDJ	Class II	2014-02-28
K140178	Ellipse Magec Spinal Bracing and Distraction System	Ellipse Technologies, Inc.	PGN	Class II	2014-02-27