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 920 of 3530

510(k) clearances, page 920 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113792	Megabeam Endocular Probe and Aspirating Endocular Probe	Biolitec Medical Devices, Inc.	GEX	Class II	2012-01-19
K113173	Nanovis Spinal System	Nanovis, LLC	NKB	Class II	2012-01-19
K113083	Truly Automatic Arm Blood Pressure Monitor	Truly Instrument Limited	DXN	Class II	2012-01-19
K112868	Dreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-Max	Dreamgard, Inc.	MQC	Unclassified	2012-01-19
K112348	Rs-4I Muscle Stimulator	RS Medical	IPF	Class II	2012-01-19
K112300	Kimguard Smart-Fold* Sterilization Wrap	Kimberly-Clark Corporation	FRG	Class II	2012-01-19
K111719	Oasys Spinal System	Howmedica Osteonics Corp	KWP	Class II	2012-01-19
K111681	Histobrush	Puritan Medical Products Company, LLC	HHT	Class II	2012-01-19
K111157	CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES	Carl Zeiss Meditec Inc	OBO	Class II	2012-01-19
K113773	St Jude Medical, Is4 Flushing/funneling Tool	Abbott Medical	KRA	Class II	2012-01-18
K112825	Avita Arm Type Blood Pressure Monitor	Avita Corporation	DXN	Class II	2012-01-18
K112612	Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim	Top Calibre Sdn Bhd	LYY	Class I	2012-01-18
K111494	Handheld Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2012-01-18
K111407	Triport, Triport+, Triport15, Quadport	Advanced Surgical Concepts	OTJ	Class II	2012-01-18
K111286	Quasar Calypso	Silver Bay, LLC	OLP	Class II	2012-01-18
K111221	Mission U500 Urine Analyzer	Acon Laboratories, Inc.	JIO	Class II	2012-01-18
K110017	Ag-608N Blood Glucose Monitoring System	Andon Medical co., Ltd	NBW	Class II	2012-01-18
K113730	Parcus 35 Knotless Peek Cf Push-in Suture Anchors, Parcus 45 Knotless Peek Cf Push-in Suture Anchors	Parcus Medical, L.L.C.	MBI	Class II	2012-01-17
K113497	Hyperion	Cefla S.C. Cefla Dental Group	MUH	Class II	2012-01-17
K113366	Leucadia Autolok Pedicle Screw System	Phygen, LLC	NKB	Class II	2012-01-17
K113329	K2m, Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2012-01-17
K113252	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek	OVE	Class II	2012-01-17
K113248	Aerodr System with P-21	Konica Minolta Medical & Graphic, Inc.	KPR	Class II	2012-01-17
K113101	Exxcel Soft Eptee Vascular Graft-Standard Wall,thin Wall	Boston Scientific Corporation	DSY	Class II	2012-01-17
K113098	Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,contrex Plus III	Apex Biotechnology Corp.	NBW	Class II	2012-01-17
K112814	Cuffink	Cayenne Medical Inc.	MBI	Class II	2012-01-17
K112716	Osteon II	GENOSS Co., Ltd.	LYC	Class II	2012-01-17
K112441	Compressible Limb and Circulation Therapy System	Daesung Maref Co.,Ltd	IRP	Class II	2012-01-17
K120011	Heisenberg Effect Shades	3M Espe AG	EIH	Class II	2012-01-13
K113698	Scepter Xc Occlusion Balloon Catheter	Terumo Cardiovascular Systems Corporation	MJN	Class II	2012-01-13
K113490	Optima Mr450w	GE Healthcare	LNH	Class II	2012-01-13
K113410	Nnc Solid Abutment Nnc Temporary Coping for Colid Abutment Nnc Temporary Cap for Colid Abutment	Straumann USA, LLC	NHA	Class II	2012-01-13
K113093	Vantage Titan 3T	Toshibamedical Systems Corporation	LNH	Class II	2012-01-13
K113086	Acqa	Texas Medical Imaging Consultants	KPS	Class II	2012-01-13
K112852	Babi Plus Neonatal Resuscitation Bag	A Plus Medical	BTM	Class II	2012-01-13
K112730	Abutment for Competitive Implant Straumann Bone Level Connection	ZimVie US Corp LLC	NHA	Class II	2012-01-13
K112727	Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical	Medical Facets	HWC	Class II	2012-01-13
K112707	Generation C Aesthetic Self-Ligating Bracket System	Ortho Technology	NJM	Class II	2012-01-13
K112677	The Venous Assist System	Daesung Maref Co.,Ltd	JOW	Class II	2012-01-13
K112417	Various	DePuy Mitek, Inc.	MBI	Class II	2012-01-13
K112189	Thermo Pal Infrared Ear Thermometer	Digio2 International Co., Ltd.	FLL	Class II	2012-01-13
K112114	Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40	Maquet Critical Care AB	BSZ	Class II	2012-01-13
K112013	Evolve(r) Hpd 980/1470Nm Multiwavelength Diode Laser	Biolitec, Inc.	GEX	Class II	2012-01-13
K111788	Endoeye Hd II	OLYMPUS Corporation of the Americas	HET	Class II	2012-01-13
K111381	Medi-Sis Syringe Infusion System	Acacia, Inc.	LZH	Class II	2012-01-13
K111162	Slim Onebody System	Dentium Co., Ltd.	DZE	Class II	2012-01-13
K110480	Pde Photodynamic Eye	Hamamatsu Photonics K.K.	OWN	Class II	2012-01-13
K110305	Cry-Actrackercam	Brymill Cryogenic Cystems	FQZ	Class I	2012-01-13
K110083	V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode	Respironics, Inc.	CBK	Class II	2012-01-13
K113699	Tampax(r) V Plastic Applicator Tampons, Unscented	Procter & Gamble Co.	HEB	Class II	2012-01-12