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 762 of 3530

510(k) clearances, page 762 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141631	Aquarius Extension Feeding Set	Degania Silicone, Inc.	KNT	Class II	2014-07-28
K141071	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Health Care	FRG	Class II	2014-07-28
K140921	Coroent Small Interbody System	Nu Vasive, Incorporated	ODP	Class II	2014-07-28
K140479	Coroent Xl-F System	Nu Vasive, Incorporated	OVD	Class II	2014-07-28
K140469	Mr Syringe Dual Pack	Coeur, Inc.	DXT	Class II	2014-07-28
K140313	Stopsbleeding Topical Hemostat Powder and Foam	Coag Medical, LLC	QSY	Unclassified	2014-07-28
K140071	Humelock II Cemented Shoulder System	Fx Shoulder Solutions SAS	KWT	Class II	2014-07-28
K133809	Osteofab Patient Specific Facial Device	Oxford Performance Materials, Inc.	KKY	Class II	2014-07-28
K133077	Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set	Generica Medical International	KNT	Class II	2014-07-28
K141838	Sol Portable Diode Laser Unit (with Wireless Foot Control)	Regulatory Technology Services, LLC	GEX	Class II	2014-07-25
K141736	Philips Prograde; Philips Eleva Workspot for Digital Diagnost	Philips Medical Systems DMC GmbH	MQB	Class II	2014-07-25
K141675	Voluson P6, Voluson P8	GE Healthcare	IYN	Class II	2014-07-25
K141367	Ls Series Linear Stapler and Reloads, Clc Series Curved Linear Cutter and Reloads, Lc Series Linear Cutter and Reloads	Touchstone International Medical Science Co., Ltd.	GDW	Class II	2014-07-25
K141311	0.9% Sodium Chloride Injection, Usp Bd Posiflush; Sp Syringe, Sf Syringe	Becton Dickinson & Co	NGT	Class II	2014-07-25
K141193	Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0	Abbott Medical	PHC	Class II	2014-07-25
K141116	Liaison Xl Analyzer	Diasorin Inc.	LOL	Class II	2014-07-25
K140846	Eds Combo-Rinse	Essential Dental Systems, Inc.	KJJ	Unclassified	2014-07-25
K140777	Zquiet-Sa	Sleeping Well, LLC	LRK	Class II	2014-07-25
K140770	Mlx - Medial Lateral Expandable Lumbar Interbody System	Nu Vasive, Incorporated	MAX	Class II	2014-07-25
K140635	Cocoon Convective Warming System	Care Essentials Pty., Ltd.	DWJ	Class II	2014-07-25
K140553	Endowrist Stapler 45 and Stapler 45 Reloads	Intuitive Surgical, Inc.	NAY	Class II	2014-07-25
K140494	V-Pro Sterilization Tray/ Sterilization Mat	STERIS Corporation	KCT	Class II	2014-07-25
K140250	3M Steri-Drape Chg Antimicrobial Incise Drape	3M Healthcare	KKX	Class II	2014-07-25
K134029	Belter Blood Pressure Meter	Shenzhen Belter Health Measurement and Analysis TE	DXN	Class II	2014-07-25
K133658	Cdi Blood Parameter Monitoring System 500	Terumo Cardiovascular Systems Corporation	DRY	Class II	2014-07-25
K133466	Cellvizio 100 Series System with Confocal Miniprobes (Tm)	Mauna Kea Technologies	OWN	Class II	2014-07-25
K133444	Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System	Medtronic Navigation, Inc	HAW	Class II	2014-07-25
K131720	Hivox Self Adhesive Electrode Gel Pads	Hivox Biotek Inc.	GXY	Class II	2014-07-25
K121119	Bna Analysis System	Eiminda, Ltd.	OLU	Class II	2014-07-25
K141750	Hemocue Hba1c 501 Glycosylated Hemoglobin Monitoring System	Infopia Co, Ltd.	LCP	Class II	2014-07-24
K141711	Pontis 3Mm Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis Ultra-High Molecular Weight Polye	Pontis Orthopaeeics, LLC	MBI	Class II	2014-07-24
K141489	Linos Moh Hand Plating System	KLS-Martin L.P.	HRS	Class II	2014-07-24
K141173	Amplivue Gas Assay	Ortho-Clinical Diagnostics, Inc.	PGX	Class II	2014-07-24
K141028	Colonglide Lubricant	Pediatric Pharmaceuticals, Inc.	KMJ	Class I	2014-07-24
K140890	Nitrile Powder Free Examination Gloves (White/dawn Blue/dark Violet Blue (Dvbu)/cobalt Blue (Cblu)	Hartalega NGC Sdn Bhd	LZA	Class I	2014-07-24
K140523	Re-Trace Ureteral Access Sheath, 12/14 Ch/fr, Length 35 Cm, Length 45 Cm	MEDLINE INDUSTRIES, LP - Northfield	FED	Class II	2014-07-24
K140498	V-Pro 60 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2014-07-24
K140295	Gis Endoscopic Optical Lens	GI Scientific LLC	FDS	Class II	2014-07-24
K140281	Flexi-Lume LED System	Epic Medical Concepts & Innovations	EBZ	Class II	2014-07-24
K140096	Hmicro Wired C-Patch Electrode, Trade Name Subject to Change	Hmicro, Inc.	DRX	Class II	2014-07-24
K133906	C-Jaws Cervical Compressive Staple	Medicrea International	PHQ	Class II	2014-07-24
K133683	Micr02 Osa Device	Microdental, Inc.	LRK	Class II	2014-07-24
K133670	Headphones, Patient Alert, Standalone Interface	NeoCoil, LLC	LNH	Class II	2014-07-24
K133336	Pjur(r) Siliconegel, Pjur(r) Basic Personal Glide, Pjur(r) Light, Pjur(r) Med Premium Glide	pjur group Luxembourg S.A.	NUC	Class II	2014-07-24
K133156	Advia Centaur Vitamin D Total (Vitd) Assay;advia Centaur Vitd Total Calibrators,quality Control & Master Control Materia	Siemens Healthcare Diagnostics Inc.	MRG	Class II	2014-07-24
K132907	Plif Lite and Tlif Lite	Sintea Plustek, LLC	MAX	Class II	2014-07-24
K132749	Nobelprocera Overdenture Bar	Nobel Biocare USA LLC	NHA	Class II	2014-07-24
K131926	Thermopulse	Ibramed Equipamentos Medicos	IMJ	Class II	2014-07-24
K131226	Novaprobe LED Light Source	Novaprobe Incorporated	FCW	Class II	2014-07-24
K141784	Ortho Solutions Ultos Plating System	Ortho Solutions Inc	HRS	Class II	2014-07-23