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 2026-10-26, 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 752 of 3530

510(k) clearances, page 752 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133603	Philips CT Dynamic Myocardial Perfusion (Dmp) Application	Philips North America LLC	JAK	Class II	2014-09-25
K142376	Palomar Icon Aesthetic System	Cynosure, LLC	GEX	Class II	2014-09-24
K142261	Ultraverse 035 PTA Balloon Dilatation Catheter	Bard Peripheral Vascular Inc	LIT	Class II	2014-09-24
K142123	Reach Access Telemedicine Dose Calculator	Reach Health, Inc.	NDC	Class II	2014-09-24
K141829	Glucovitaal H1a Blood Glucose Monitoring System	Ceragem Medisys, Inc.	NBW	Class II	2014-09-24
K141591	Smartgraft 30 System	Ingeneron, Inc.	MUU	Class II	2014-09-24
K140837	Lucid Ly	Bio-Med USA, Inc.	GEX	Class II	2014-09-24
K140556	Conchasmart Breathing Circuit	Teleflex Medical	BTT	Class II	2014-09-24
K140097	Amt Endotracheal Tube Bridle Retention System	Applied Medical Technology Inc	CBH	Class I	2014-09-24
K133456	Power-Trialysis Short-Term Dialysis Catheter	C.R. Bard Inc	NIE	Class II	2014-09-24
K132121	Statstrip Glucose Hospital Meter System	Nova Biomedical Corporation	PZI	Class II	2014-09-24
K142112	4Web Spinal Implant Products	4Web, Inc.	MAX	Class II	2014-09-23
K141616	Sterilization Cassette	Oticon Medical AB	KCT	Class II	2014-09-23
K141500	Optio-C Anterior Cervical System	Zimmer Spine, Inc.	KWQ	Class II	2014-09-23
K141483	Biospace Body Composition Analyzer	Biospace Inc.	MNW	Class II	2014-09-23
K141103	Intramedullary Nail and Screws-Neonail	Neoortho Produtos Ortopedicos S/a	HSB	Class II	2014-09-23
K141255	Simex Subglottic Aspiration System	Simex Medizintechnik GmbH	BTA	Class II	2014-09-22
K140719	Picosure Workstation	Cynosure, LLC	GEX	Class II	2014-09-22
K140349	Starbright 5% Sodium Fluoride Varnish	Nanova Biomaterials Inc	LBH	Class II	2014-09-22
K140077	Albaad Plastic Applicator Tampons Unscented	Albaad, Ltd.	HEB	Class II	2014-09-22
DEN140019	T2candida and T2dx Instrument	T2biosystems, Inc.	PII	Class II	2014-09-22
K142527	Extension Set with BD Q-Syte Luer Access Split Septum	Acacia, Inc.	FPA	Class II	2014-09-19
K142397	Predicate III Guidewire	Lake Region Medical	OCY	Class II	2014-09-19
K141998	Sama Disposable Blood Pressure Cuff Barriers	Pinghu Sama Medical Packing Co., Ltd.	DXQ	Class II	2014-09-19
K141806	Clear Guide One	Clear Guide Medical	IYO	Class II	2014-09-19
K141669	Surgimap	Nemaris, Inc.	LLZ	Class II	2014-09-19
K141472	Vantage Elan	Toshiba America Medical Systems, In.C	LNH	Class II	2014-09-19
K141453	Ilumien Optis, Dragonfly Optis Imaging Catheter	Lightlab Imaging, Inc.	DQO	Class II	2014-09-19
K141437	Xlr8 Plus (Xlr8+)	Genadyne Biotechnologies, Inc.	OMP	Class II	2014-09-19
K140634	extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit	Devon Medical, Inc.	OMP	Class II	2014-09-19
K133852	Apollo Balloon Dilatation Catheter	BrosMed Medical Co.,Ltd.	LOX	Class II	2014-09-19
K133753	Mome ECG Continuous Detection and Arrhythmia Detector	Infobionic, Inc.	QYX	Class II	2014-09-19
K133717	Longbow Spacer System	Life Spine	MAX	Class II	2014-09-19
K133298	Endo Smart	Meta Biomed Co., Ltd.	EKX	Class I	2014-09-19
K133223	Xenmatrix Ab Surgical Graft	C.R. Bard Inc	PIJ	Class II	2014-09-19
K133050	One Plus Implant System	Osseofuse, Inc.	DZE	Class II	2014-09-19
K142325	Veenstra Instruments VDC-506 Dose Calibrator	Comecer Netherlands B.V.	KPT	Class II	2014-09-18
K142181	Randox Aldolase Calibration Serum	Randox Laboratories, Limited	JIT	Class II	2014-09-18
K141985	True Ba V Balloon Valvuloplasty Catheter	C.R. Bard Inc	OZT	Class II	2014-09-18
K141895	Mobilediagnost Wdr	Sedecal S.A.	IZL	Class II	2014-09-18
K141885	Cmdr-2St & Cmdr-2Slwt Digital Portable X-Ray	Minxray Inc	IZL	Class II	2014-09-18
K141697	Xtrafix External Fixation System, Xtrafix Small External Fixation System	Zimmer GmbH	KTT	Class II	2014-09-18
K141696	Edwards Esheath Introducer Set	Edwards Lifesciences LLC	DYB	Class II	2014-09-18
K141670	Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2014-09-18
K141607	Dental Imaging Software	Trophy	LLZ	Class II	2014-09-18
K141477	Discovery Iq	GE Healthcare	KPS	Class II	2014-09-18
K141074	Cortex Id Suite	GE Healthcare	KPS	Class II	2014-09-18
K140613	Magec Spinal Bracing and Distraction System	Ellipse Technologies, Inc.	PGN	Class II	2014-09-18
K140557	Mivi 6F Guide Catheter	Mivi, LLC	DQY	Class II	2014-09-18
K140399	Ebm Ido Viewer	Ebm Technologies USA, LLC	LLZ	Class II	2014-09-18