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 931 of 3530

510(k) clearances, page 931 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113195	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Suqian Ruijang Medical Supplies Co., Ltd.	LYZ	Class I	2011-11-16
K112640	Hyperelastic Wire	Ormco Corp.	DZC	Class I	2011-11-16
K112639	The Belmont Buddy Lite Fluid Warmer	Belmont Medical Technologies	BSB	Class II	2011-11-16
K112393	Tasman	ResMed Corp	BZD	Class II	2011-11-16
K112280	Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium	Straumann USA, LLC	NHA	Class II	2011-11-16
K112276	Vizion	Trek Diagnostic Systems, Ltd.	JWY	Class II	2011-11-16
K112205	Snorerx 9.0	Consumer Health Products, Inc.	LRK	Class II	2011-11-16
K112167	Soyala Silkgel Full Face Mask	Weinmann Gerate Fur Medizin GmbH + Co. KG	BZD	Class II	2011-11-16
K111955	Medline Pneumoperitoneum Needle	MEDLINE INDUSTRIES, LP - Northfield	HIF	Class II	2011-11-16
K111773	Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate	Renu Medical, Inc.	NLF	Class II	2011-11-16
K111323	Synthes Synpor Hd Porous Polyethylene Threr Dimensional Implants	Synthes GmbH	KKY	Class II	2011-11-16
K111026	Apollo	Pollogen Ltd	GEI	Class II	2011-11-16
K110770	Healthtracker	Wistron Corporation	DXN	Class II	2011-11-16
K103818	Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary Antibody	Ventana Medical Sytems, Inc.	MXZ	Class II	2011-11-16
K113156	Sonosite Edge Ultrasound System	FUJIFILM SonoSite,Inc.	IYO	Class II	2011-11-15
K112453	Sterispineps Pedicle Screw	Safe Orthopaedics	NKB	Class II	2011-11-15
K112444	Anatomic Peek Cervical Fusion System	Medtronic Sofamor Danck USA, Inc.	ODP	Class II	2011-11-15
K112069	Rsp Glenoid Baseplate Porous Coated	Encore Medical, LP	PHX	Class II	2011-11-15
K111600	Reprocessed Hand Activate Sealer/divider	Stryker Sustainability Solutions	NUJ	Class II	2011-11-15
K111005	Ethanol Reagent, Ethanol Calibrator, Ethanol Qc Material	Medica Corp.	DIC	Class II	2011-11-15
K113279	Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light	Kettenbach GmbH & Co KG	ELW	Class II	2011-11-14
K113263	Arges Imaging Contrast Spray	Arges Imaging, Inc.	ELW	Class II	2011-11-14
K112839	Varian High Energy Linear Accelerator	Varian Medical Systems, Inc.	IYE	Class II	2011-11-14
K112406	Peri-Loc Proximal Femur Locking Bone Plates	Smith & Nephew, Inc.	HRS	Class II	2011-11-14
K112111	Acu-Sinch Repair System and Acumed Suture Anchor	Acumed LLC	HTN	Class II	2011-11-14
K111843	Acufex Director Application Anatomic Guide System	Smith & Nephew, Inc.	OLO	Class II	2011-11-14
K111840	Emerge Fractional Laser	Palomar Medical Products, Inc.	ONG	Class II	2011-11-14
K102413	Fuze: Intramedullary Internal Fixation Nail	Vilex LLC	HSB	Class II	2011-11-14
K113063	CT-Guide Needle Guidance System	Activiews, Ltd.	JAK	Class II	2011-11-10
K113046	Ameditech Immutest Milti-Drug Screen	Ameditech, Inc.	DKZ	Class II	2011-11-10
K113019	Profemur Xm Wingless Distal Centralizer, Perfecta Distal Centralizer	Wrightmedicaltechnologyinc	KWA	Class III	2011-11-10
K112838	Vasopress Reprocessed Dvt Leg / Foot Garments	Compression Therapy Concepts, Inc.	JOW	Class II	2011-11-10
K112558	Digital Flat Panel X-Ray Detector	Samsung Mobile Display Co., Ltd.	MQB	Class II	2011-11-10
K112475	Xtract Syringe Key System	Xtract Solutions	FMF	Class II	2011-11-10
K112357	Vessel Guardian	Lexion Medical, LLC.	HIF	Class II	2011-11-10
K112321	Cs 1200	Eastman Kodak Company	EIA	Class I	2011-11-10
K111984	Spi Vario Angled Abutment	Thommen Medical AG	NHA	Class II	2011-11-10
K111932	Iglucose System	Positiveid Corporation	NBW	Class II	2011-11-10
K111764	Chartis Console	PULMONX, Corp.	BZG	Class II	2011-11-10
K111716	Knotless Suture Fixation System	Core Essence Orthopaedics, LLC	MBI	Class II	2011-11-10
K111557	X-Force	Seven Seas Distribtion and Manufacturing, LLC	NYN	Class II	2011-11-10
K111487	Nh-301 Ambulatory ECG Analysis Software	Norav Medical Ltd.	MLO	Class II	2011-11-10
K110463	Pcecg-1200 System with Modular ECG Analysis System (Means)	Norav Medical Ltd.	MWI	Class II	2011-11-10
K103058	Multifunction Keito	Aguiflai Iberica S.L.	DXN	Class II	2011-11-10
K103031	Bmr Face	Bio-Medical Research, Ltd.	NFO	Class II	2011-11-10
K102925	Nexgen Expandable Catheter	Nexgen Medical Systems, Inc.	DYB	Class II	2011-11-10
K113110	Axera Access System	Arstasis, Inc.	DYB	Class II	2011-11-09
K112988	Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms per Dm Squared or Less of Water Soluble	Northstar Healthcare Holdings	LYY	Class I	2011-11-09
K112985	Catheter Connections' Dualcap Duo	Catheter Connections, Inc.	QBP	Class II	2011-11-09
K112688	Ensite Velocity System V.3.0	Abbott Medical	DQK	Class II	2011-11-09