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 1359 of 3531

510(k) clearances, page 1359 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042076	Fujinon G5 Duodenscopes; G5 Duodenoscopes, Ed-450Xt5, Ed-250Xt5	FUJIFILM Healthcare Americas Corporation	FDT	Class II	2004-11-18
K041869	Self Retaining Bicanaliculus Intubation Set	Fci Ophthalmics, Inc.	OKS	Unclassified	2004-11-18
K041172	Basba E-Machine	Basba, Inc.	GZJ	Class II	2004-11-18
K034005	Sds-4I	Skylark Device & Systems Co., Ltd.	IPF	Class II	2004-11-18
K032315	Iop8 Intra Operative Probe	Huntleigh Healthcare Ltd.	ITX	Class II	2004-11-18
K043078	Nemio Diagnostic Ultrasound System, Model Ssa-550A	Toshiba America Medical Systems, In.C	IYO	Class II	2004-11-17
K043012	Omnipulse Mini, Model 2120	Trimedyne, Inc.	GEX	Class II	2004-11-17
K043008	Surgrx Enseal Vessel Sealing & Hemostasis System	Surgrx, Inc.	GEI	Class II	2004-11-17
K042986	Modification to Synthes (USA) (Synthes) Low Profile Neuro System	Synthes (USA) Products LLC	GXR	Class II	2004-11-17
K042980	Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software	Abbott Medical	FRN	Class II	2004-11-17
K042830	Powder Free Vinyl Synthetic Examination Gloves	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-11-17
K042761	Wristore Distal Radius Fracture Fixator, 4600 Series	Zimmer GmbH	KTT	Class II	2004-11-17
K042580	Tidi Brand Sterilization Wrap	Banta Healthcare Group, Ltd.	FRG	Class II	2004-11-17
K042559	Gem-Twin TENS/ Models Gm3xy/z	Gemore Technology Co., Ltd.	GZJ	Class II	2004-11-17
K042468	Ivent 201 Portable Ventilator	Versamed Medical Systems, Inc.	CBK	Class II	2004-11-17
K042459	Synchron Lx Systems Hemoglobin A1c2 (Hba1c2) Reagent	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2004-11-17
K042359	Subdural Evacuating Port System Cranial Access Kit (Seps-Ca), (Seps-Cal), (Seps-Cand),models 11-0401 Ca, 11-0401-Cal	Medical Designs, LLC	JXG	Class II	2004-11-17
K042256	Ir Heat Lamp Systems: Icl 15 Hfpl System, Icl 60 Plus Hfpl System (Models 40, 100 and 250), Icl 100 Activo Scanner Syste	USA Laser Biotech, Inc.	ILY	Class II	2004-11-17
K042039	Family of Crystal 20 Monitors Model #Cs20-600,900,1300,1400,2400 & 120	Cleveland Medical Devices, Inc.	OLV	Class II	2004-11-17
K042035	Alumina Head	Fournitures Hospitalieres Industrie	LZO	Class II	2004-11-17
K041983	Option-Vm Urinary Catheter/adpater, Models Mv39016, Mva39016	Opticon Medical, Inc.	EZL	Class II	2004-11-17
K041632	Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	OTO	Class II	2004-11-17
K041323	Pulsed Light Therapy System, Model Prima	New Star Lasers, Inc.	GEX	Class II	2004-11-17
K033095	Smoke Evacuation Attachement	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2004-11-17
K043016	Sonoline Orchid Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-11-16
K042895	Synthes Lcp Dynamic Helical Hip System, Additional Helix Blades	Synthes (USA) Products LLC	KTT	Class II	2004-11-16
K042889	Dynamometer - Model Fce and Model Msc	Ametek, Inc.	LBB	Class II	2004-11-16
K042877	Microverter Ureteral Access Sheath	Percutaneous Systems, Inc.	KNY	Class II	2004-11-16
K042824	Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens	CooperVision, Inc.	LPL	Class II	2004-11-16
K042766	Orthofix Volar Distal Radial Plate	Orthofix SRL	HRS	Class II	2004-11-16
K042551	Multi-Chem Calibrator a	FUJIFILM Healthcare Americas Corporation	JIX	Class II	2004-11-16
K042083	Modification to Visitome 20-10 Microkeratome	Biovision, Inc.	HNO	Class I	2004-11-16
K041937	Restitu	Resonant Medical, Inc.	IYE	Class II	2004-11-16
K041443	Oti Alumina Ceramic Femoral Head System	Osteoimplant Technology, Inc.	LZO	Class II	2004-11-16
K040912	Hydrogel Canalicular Plug	Partners in Biomaterials, Inc.	LZU	Unclassified	2004-11-16
K042733	Standard Imaging Pipspro Qa Software System	Standard Imaging Inc.	LHO	Class I	2004-11-15
K042682	Ambu Spur II. Adult Single Patient Resuscitator	Ambu, Inc.	BTM	Class II	2004-11-15
K042637	The 5.0 X 6.0Mm Dental Implant	Bicon, LLC	DZE	Class II	2004-11-15
K042422	D3 Chroma	Sybron Dental Specialties, Inc.	DYH	Class II	2004-11-15
K042197	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration	Ed. Geistlich Soehne AG Fuer Chemische Industrie	NPL	Class II	2004-11-15
K041951	Xpect Clostridium Difficile Toxin A/b	Remel Inc	LLH	Class I	2004-11-15
K041852	Mr Tested Fiber Optic Short Laryngoscope Handle, Model 310002	Minrad, Inc.	CCW	Class I	2004-11-15
K041007	Millenium, Models 2000, 2001 and 2002	Hyperbaric for Life LLC	CBF	Class II	2004-11-15
K040660	Sterichek Glutaraldehyde Reagent Strips	Hach Company	LIF	Class II	2004-11-15
K042690	Ascension Pyrosphere (Pcs)	Ascension Orthopedics, Inc.	KYI	Class II	2004-11-13
K042914	Opus Magnum Knotless Anchor with Inserter Handle	Opus Medical, Inc.	MBI	Class II	2004-11-12
K042909	Stellartech Coagulation System, Models 1100C-115A & 1100C-230A	Stellartech Research Corp.	GEI	Class II	2004-11-12
K042908	Rx Accunet 2 Embolic Protection System	Boston Scientific Corporation	NTE	Class II	2004-11-12
K042855	Intuitive Surgical Harmonic Curved Shears Instrument	Intuitive Surgical, Inc.	NAY	Class II	2004-11-12
K042845	The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, and Mp90 Intellivue Patient Monitors	Philips Medizin Systeme Boblingen GmbH	MSX	Class II	2004-11-12