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 2026-11-02, 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 956 of 3531

510(k) clearances, page 956 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111658	Affinity Cp Centrifugal Bllod Pump with Carmeda Bioactive Surface	Medtronic, Inc.	KFM	Class II	2011-06-28
K111340	Head and Neck Immobilization System, Body Immobilization System	Medtec LLC	LNH	Class II	2011-06-28
K111180	Vasomedical-Biox 12- Channel Ambulatory ECG Holter Recorder Model 1304, Vasomedical-Biox 3- Channel Miniature Ambulatory	Vasomedical, Inc.	DSH	Class II	2011-06-28
K111063	Vital Serum Controls	Vital Diagnostics (Manufacturing) Ptyltd	JJY	Class I	2011-06-28
K110908	Aptus Foot 3.5 System	Medartis AG	HRS	Class II	2011-06-28
K110752	Highland Instruments Ces and Tus Instrument Holder	Highland Instruments	ITX	Class II	2011-06-28
K110712	Drytouch Suction Stimulator Probe	Neurovision Medical Products Inc	ETN	Class II	2011-06-28
K110695	Bipolar HF Device	Aesculap Inc	GEI	Class II	2011-06-28
K110243	Medart Diode Laser System & Accessories	MEDART ApS	GEX	Class II	2011-06-28
K110035	Indiko	Thermofisher Scientific Oy	JJE	Class I	2011-06-28
K103807	Ivas 2-10Mm (10 Guage) Ballon Catheter	Stryker Corp.	NDN	Class II	2011-06-28
K103417	Halifax Biomedical Tanatlum Bead Set	Halifax Biomedical Inc.	NEU	Class II	2011-06-28
K101692	Patient Monitor	Contec Medical System Co., Ltd.	MHX	Class II	2011-06-28
DEN100017	Lipflow Thermal Pulsation System (Formerly Manual Mini System)	TearScience, Inc.	ORZ	Class II	2011-06-28
K111193	Apex Arc Hip Stem	Omni Life Science, Inc.	LZO	Class II	2011-06-27
K110968	Proflu+ Assay	Gen-Probe Prodesse, Inc.	OCC	Class II	2011-06-27
K110950	Consensus Knee System	Consensus Orthopedics, Inc.	MBH	Class II	2011-06-27
K101509	U-Right Td-4279 Blood Glucose Monitoring System, Fora Gd40/td-4272 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-06-27
K111638	Impax Volume Viewing	AGFA Healthcare Corp.	LLZ	Class II	2011-06-24
K111513	Cx50 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2011-06-24
K111233	Supris Retropubic Sling System	MEDLINE INDUSTRIES, LP - Northfield	OTN	Class II	2011-06-24
K111133	Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 Mg or Less)	Ssc Surat Thani	LYY	Class I	2011-06-24
K111096	Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory	Vasomedical, Inc.	DSH	Class II	2011-06-24
K111091	Merit Medical 20 Ml Syringe	Merit Medical Systems, Inc.	FMF	Class II	2011-06-24
K110900	Disposable Thyroid Collar	Bloxr Corporation	KPY	Class I	2011-06-24
K110730	Monaco Rtp System	Elekta Limited	MUJ	Class II	2011-06-24
K110704	Sensi	Diacoustic Medical Devices (Pty), Ltd.	DQD	Class II	2011-06-24
K110684	Medcad Accushape (Tm) Peek Patient Specific Cranial / Craniofacial Implant	Vanduzen dba Medcad	GXN	Class II	2011-06-24
K110630	F10	Mediana Co., Ltd.	KNG	Class II	2011-06-24
K110609	Epiducer Lead Delivery System	Abbott Medical	LHG	Class II	2011-06-24
K110566	Viberect Penile Vibratory Stimulation Device	Reflexonic, LLC	KXQ	Class II	2011-06-24
K110545	Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa Pk)	Smith & Nephew, Inc.	MBI	Class II	2011-06-24
K110518	Ibag	Future Path Medical, LLC	KNX	Class II	2011-06-24
K110459	Surefire Infusion Catheter System	Surefire Medical, Inc.	DQO	Class II	2011-06-24
K110344	Inomax Dsir (Delivery System)	Mallinckrodt Manufacturing LLC	MRN	Class II	2011-06-24
K103520	Carpentier-Edwards Physio Tricuspid Annuloplasty Ring	Edwards Lifesciences LLC	KRH	Class II	2011-06-24
K102771	Biopsy Handy, MRI Biopsy Handy	SOMATEX Medical Technologies GmbH	KNW	Class II	2011-06-24
K111657	Affinity Cp Centrifugal Blood Pump with Balance Biosurface	Medtronic, Inc.	KFM	Class II	2011-06-23
K111581	15 Esthetic Abutment Nobelactive 03.0 1.5Mm, 15 Esthetic Abutment Nobelactive 03.0 3Mm, 15 Esthetic Abutment Nobelactive	Nobel Biocare AB	NHA	Class II	2011-06-23
K110930	Active Waste Gas Scavenger	G. Dundas Co.	CBN	Class II	2011-06-23
K110859	Metal Opaquer	Apex Dental Materials, Inc.	EBF	Class II	2011-06-23
K110826	Curos Port Protector	Ivera Medical, Inc.	QBP	Class II	2011-06-23
K110724	Surgical Procedure Packs	Omnia SpA	FYA	Class II	2011-06-23
K110635	Inomax Ds(ir) (Delivery System)	Mallinckrodt Manufacturing LLC	MRN	Class II	2011-06-23
K110500	Stat-Mat Minor	Macpherson Medical, Inc.	KCT	Class II	2011-06-23
K110306	Sound Surgical Vaser 2.1 Lipo System	Solta Medical, Inc.	QPB	Class II	2011-06-23
K110239	Lzi Cannabinoids (Cthc) Homogeneous Enzyme Immunoassay, Calibrators, Control	Lin-Zhi International Inc	LDJ	Class II	2011-06-23
K103562	Centurion Pressure Injectable Extension Set	Centurion Medical Products, LP	FPA	Class II	2011-06-23
K102412	Vista Digital Opthalmoscope	Eyequick.Llc	HKI	Class II	2011-06-23
K101049	Wart Freeze	Koninklijke Utermohlen NV	GEH	Class II	2011-06-23