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 901 of 3530

510(k) clearances, page 901 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112790	Axis-Shield 3-Reagent Homocysteine Assay for Synchron	Axis-Shield Diagnostics, Ltd.	LPS	Class II	2012-05-07
K121057	Cook Celect and Gunther Tulip Vena Cava Filter Sets	William Cook Europe ApS	DTK	Class II	2012-05-04
K121015	Emboshield Nav6 Embolic Protection System	Abbott Vascular	NTE	Class II	2012-05-04
K120548	Hlic Needle-Less Valve	Health Line International Corporation	FPA	Class II	2012-05-04
K120518	End Tidal CO2 Nasal Cannula	Care Fusion	CCK	Class II	2012-05-04
K120507	United U2 Femoral Component, Ps, #7	United Orthopedic Corp.	JWH	Class II	2012-05-04
K120364	Unimed Disposable Blood Pressure Cuff	Unimed Medical Supplies Inc	DXQ	Class II	2012-05-04
K120362	Metafix Femoral Stem for Hemi-Arthroplasty	Corin USA	LZO	Class II	2012-05-04
K120171	Accusonic Advantage	Metron Medical Australia, Pty, Ltd.	IMI	Class II	2012-05-04
K120141	Kensey Nash Bone Void Filler Xc	Kensey Nash Cororation	MQV	Class II	2012-05-04
K120020	Vivix-S	Vieworks Co., Ltd.	MQB	Class II	2012-05-04
K113689	Dukal Lubricating Jelly	Dukal LLC	KMJ	Class I	2012-05-04
K113340	Kimberly-Clark Child's Facemask	Kimberly-Clark Corporation	OXZ	Class II	2012-05-04
K112797	Powerflex Pro Percutaneous Transluminal Angioplasty Catheter	Cordis US Corp.	LIT	Class II	2012-05-04
K112671	Sterilcontainer System	Aesculap Inc	KCT	Class II	2012-05-04
K112665	Tri Auto Mini - Endodeontic Treatment Motorized Handpiece	J. Morita USA, Inc.	EKX	Class I	2012-05-04
K112549	IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver	Covalontechnologies, Inc.	FRO	Unclassified	2012-05-04
K112279	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	DZE	Class II	2012-05-04
K121194	Endo Clip III 5Mm Clip Applier	Medtronic, Inc.	FZP	Class II	2012-05-03
K121182	Vialok Non-Vented	Yukon Medical, LLC	LHI	Class II	2012-05-03
K121037	Lospa Tibial Base Plate	Corentec Co., Ltd.	JWH	Class II	2012-05-03
K121020	Viper System	DePuy Spine, Inc.	NKB	Class II	2012-05-03
K121006	Ensite Array Multi-Electrode Diagnostic Catheter	Abbott Medical	MTD	Class II	2012-05-03
K120768	Es Flow	Spident Co., Ltd.	EBF	Class II	2012-05-03
K120704	3M Littmann Telesteth Online Ausculation System	3M Company	DRG	Class II	2012-05-03
K120431	Halo90 Ultra Ablation Catheter	Medtronic, Inc.	GEI	Class II	2012-05-03
K120359	Ortholoc 3Di Hallux System	Wrightmedicaltechnologyinc	HRS	Class II	2012-05-03
K120351	Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip Ca	I-SENS, Inc.	NBW	Class II	2012-05-03
K120344	Radiapak Brachytherapy Applicator Balloon Device	Radiadyne, LLC (Specification Developer)	JAQ	Class II	2012-05-03
K120335	Embrace Thermoplastic	Bionix Development Corp.	IYE	Class II	2012-05-03
K113812	Atal-8	Atlaim	MQB	Class II	2012-05-03
K113660	Cold Pack, Plastic Applicator (Medical Grade)-Non-Chemical	Cryotherapy Products, Inc.	LKX	Unclassified	2012-05-03
K113341	Guideshot Option, Scenaria Whole-Body X-Ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2012-05-03
K113216	Rapidpoint 500 Blood Gas Analyer	Siemens Healthcare Diagnostics Inc.	KHP	Class I	2012-05-03
K112995	Gem Premier 4000	Instrumentation Laboratory Co.	CEM	Class II	2012-05-03
K112083	Lifeglobal Total, Total for Fertilization, Total W/hepes, Htf Total, Htf Total W/hepes	<Genx> Intl., Inc.	MQL	Class II	2012-05-03
K111409	Aptima Combo 2 Assay	Hologic, Inc.	LSL	Class II	2012-05-03
K102577	Force Medical Im Nail System	Force Medical, Inc.	HSB	Class II	2012-05-03
K121167	Caire Companion 5 Oxygen Concentrator	Caire, Inc.	CAW	Class II	2012-05-02
K121139	Accumesh Deployment System	Medtronic, Inc.	ORQ	Class II	2012-05-02
K120983	Ultraflex Esophageal Ng Stent System	Boston Scientific Corporation	ESW	Class II	2012-05-02
K120981	2.6F X 20Cm Vascu-Picc 2.6F X 50Cm Vascu-Picc	Medical Components, Inc.	LJS	Class II	2012-05-02
K120980	1.9F X 20Cm Vascu-Picc 1.9F X 50Cm Vascu-Picc	Medical Components, Inc.	LJS	Class II	2012-05-02
K120978	Osteobridge Ika Knee Arthodesis Nail with Collar	Merete GmbH	HSB	Class II	2012-05-02
K120438	Flash (Different Materials)	3M Deutschland GmbH	ELW	Class II	2012-05-02
K120261	Pps Pi Pressure Injectable Safety Huber Needle without Lateral Injection Site, Pps Pi Pressure Injectable Safety Huber	Perouse Medical	FPA	Class II	2012-05-02
K120184	Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White Colored	Encompass Medical Supplies, Inc Limited	LZA	Class I	2012-05-02
K120168	Lullaby LED Phottherapy System	Wipro GE Healthcare Private Ltd.	LBI	Class II	2012-05-02
K120023	Zeltiq Coolsculpting	Zeltiq Aesthetics Inc	OOK	Class II	2012-05-02
K113511	Echostar Spica 1.5T Mr System	Alltech Medical Systems America, Inc.	LNH	Class II	2012-05-02