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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1414 of 3531

510(k) clearances, page 1414 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020983	Jostra Suckers, Model Js	Jostra AG	DWF	Class II	2004-01-30
K040114	Abbott Data Port Pc, Model 12181	Abbott Medical	FRN	Class II	2004-01-29
K034058	Spherical Tip Coronary Ostial Cannula, Model 30011	Medtronic, Inc.	DWF	Class II	2004-01-29
K033938	Clearfil Protect Bond	Kuraray Medical, Inc.	KLE	Class II	2004-01-29
K033500	Bd Careflow Central Venous Catheter	Becton Dickinson & Co	FOZ	Class II	2004-01-29
K033120	Scaletron Piezo Ultrasound Scaler	Pac-Dent International (Suzhou), Ltd.	ELC	Class II	2004-01-29
K032214	Medonic Ca620/530 Hematology Analyzer	Boule Medical AB	GKZ	Class II	2004-01-29
K030655	Holotc Ria	Axis-Shield Biochemicals, ASA	CDD	Class II	2004-01-29
K030418	Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System	Makai Marine Industries, Inc.	CBF	Class II	2004-01-29
K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-01-28
K034037	Sky Bone Expander System	Disc-O-Tech Medical Technologies, Ltd.	HRX	Class II	2004-01-28
K033532	Asia Pacific Latex Sdn. Bhd. Polymer Coated Powder Free Latex Examination Gloves	Asia Pacific Latex Sdn Bhd	LYY	Class I	2004-01-28
K033530	Asia Pacific Latex Sdn. Bhd. Powder Free Latex Examination Gloves	Asia Pacific Latex Sdn Bhd	LYY	Class I	2004-01-28
K033456	Evolve Radial Plate	Wrightmedicaltechnologyinc	HRS	Class II	2004-01-28
K033447	Cliploc Soft Tissue Marker 18G/100mm (4), /130Mm (5 1/8), /150Mm (6), Models 12370, 12372, 12376	Mri Devices Corp.	NEU	Class II	2004-01-28
K033349	Ac-1 Sp02 Adaptor Cable, Model Ac-1	Masimo Corporation	DQA	Class II	2004-01-28
K032882	Recom Battery-Operated Ambulatory Digital Wireless ECG Monitor, Model 100	Recom Managed Systems, Inc.	MWJ	Class II	2004-01-28
K032263	3I Patient-Specific Dental Abutment and Overdenture Bar	ZimVie US Corp LLC	DZE	Class II	2004-01-28
K032235	Modification to Triage B-Type Natriuretic Peptide (Bnp) Test	Biosite Incorporated	NBC	Class II	2004-01-28
K032141	Secumax Blood Collection System	Tiger Meditech Incorporated	FMI	Class II	2004-01-28
K031167	High Precision Body Weight Monitor with Body Fat Index	Idt Technology Limited	MNW	Class II	2004-01-28
K023713	Sonoprep Impedance Diagnostics (Idx) System, Model D1000	Sontra Medical, Inc.	KRC	Class II	2004-01-28
K040044	Heel Snuggler, Model 99047	Respironics, Inc.	MPO	Class I	2004-01-27
K033772	Shiraz-Java Spinal Fixation System	Spine Next America	MNI	Class II	2004-01-27
K033621	Ndi Passive Spheres	Northern Digital Inc.	HAW	Class II	2004-01-27
K033508	Plus Pivot Link Universal System	Spine Vision, Inc.	MNI	Class II	2004-01-27
K033381	Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate and Diluent, Aquarius Model	Discus Dental LLC	MED	Class II	2004-01-27
K032514	Ac Applicator, Aurora Ac	Syneron Medical, Ltd.	GEX	Class II	2004-01-27
K033779	Vianox Delivery System, Model II	Pulmonox Medical, Inc.	MRN	Class II	2004-01-26
K033309	Premier Implant Cement, Model 3001450	Premier Dental Products Co	EMA	Class II	2004-01-26
K033302	Nichols Advantage Bio-Intact Pth (1-84) Assay, Model 62-7040	Nichols Institute Diagnostics	CEW	Class II	2004-01-26
K032112	P0rtex Reinforced Tracheal Tube (Cuffed and Uncuffed)	Abbott Medical	BTR	Class II	2004-01-26
K033760	One Coat Se Bond	Coltene /Whaledent AG	KLE	Class II	2004-01-23
K033686	Port-a-Cath II Regional Arterial Portal System	Abbott Medical	LJT	Class II	2004-01-23
K033667	Carrara Press System	Dentsply Intl.	EIH	Class II	2004-01-23
K033193	Sonosens	Friendly Sensors AG	NKI	Class II	2004-01-23
K032667	Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)	Focus Medical, LLC.	GEX	Class II	2004-01-23
K031809	Perio Protect Tray	Perio Protect LLC	KMT	Class I	2004-01-23
K031367	Duopath Verotoxins Glisa Test	EMD Millipore Corporation	GNA	Class I	2004-01-23
K030780	Newport E500 Wave Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2004-01-23
K030598	Medisiss Reprocessed Ultrasonic Surgical Instruments	Medisiss	NLQ	Unclassified	2004-01-23
K040028	Ca-1500	R2 Technology, Inc.	LLZ	Class II	2004-01-22
K033991	Modification to Laparoshield Conditioned Insufflation Set	Pall Medical	HIF	Class II	2004-01-22
K033989	Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69	Medtronic Inc. Cardiac Rhythm Management	DQY	Class II	2004-01-22
K033982	Modification to Vysis Urovysion Bladder Cancer Recurrence Test	Vysis	MMW	Class II	2004-01-22
K033908	N High Sensitivity Crp	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2004-01-22
K033835	Disposable Powder Free Vinyl Synthetic Examination Glove, White Color	Mdm Enterprise Corp.	LYZ	Class I	2004-01-22
K033515	Huberpro Safety Huber Infusion Set	Command Medical Products, LLC.	FPA	Class II	2004-01-22
K033403	T.s. Medical Circumcision Clamp	T.S. Medical	HFX	Class II	2004-01-22
K033019	Sunpex Technologies Model Se03	Sunpex Technology Co., Ltd.	INI	Class II	2004-01-22