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 1347 of 3531

510(k) clearances, page 1347 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043072	Gen-Probe Aptima Assay for Chlamydia Trachomatis	Hologic, Inc.	MKZ	Class I	2005-01-27
K043071	Randox Phencyclidine Assay	Randox Laboratories, Limited	LCM	Unclassified	2005-01-27
K042973	Solitude Unipolar Head	Ortho Development Corp.	KWL	Class II	2005-01-27
K042818	Panasonic Wrist Blood Pressure Monitor, Models Ew3003 and Ew3037	Matsushita Electric Works, Ltd.	DXN	Class II	2005-01-27
K042650	Biomove 3000	Curatronic, Ltd.	IPF	Class II	2005-01-27
K042623	Agilis Steerable Catheter Introducer, Model 408304	Abbott Medical	DYB	Class II	2005-01-27
K042129	F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock	Cedic S.r.l.	FPA	Class II	2005-01-27
K043596	Theraload Custom Loaded Needles, Models 200 and 125.S06	Theragenics Corp.	KXK	Class II	2005-01-26
K043583	Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003	Wrightmedicaltechnologyinc	HWC	Class II	2005-01-26
K043326	Bewell, Model Sc 20	Cycling and Health Tech. Industry R&D Center	INI	Class II	2005-01-26
K043309	Geodesic Photogrammetry System	Electrical Geodesics, Incorporated	GWQ	Class II	2005-01-26
K043264	Ldl-Ex Seiken Assay Kit	Denka Seiken Co., Ltd.	MRR	Class I	2005-01-26
K043065	Vigileo Arterial Pressure Cardiac Output/oximetry Monitor, Models Mihm1 and Mihm1p	Edwards Lifesciences LLC	DRS	Class II	2005-01-26
K042596	Lsa Helium	Lifestand	IPL	Class II	2005-01-26
K041031	Cardiostation-100 (Cs-100)	Us Clover Co.	DQK	Class II	2005-01-26
K040497	Distal Radio-Ulnar Joint Implant	Aptis Medical, LLC.	KXE	Class II	2005-01-26
K050035	Elekta Neuromag with Maxwell Filter	Elekta Neuromag Oy	OLX	Class II	2005-01-25
K050005	Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180	Intuitive Surgical, Inc.	NAY	Class II	2005-01-25
K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	IYN	Class II	2005-01-25
K043568	Equestra Fluid Delivery System	Medtronic Sofamor Danek	HRX	Class II	2005-01-25
K043530	Dvi Curing Light	Designs for Vision, Inc.	EBZ	Class II	2005-01-25
K043301	Gc Tion Gingival Protector	GC America Inc.	EIE	Class I	2005-01-25
K042594	Vanguard Reprocessed Non-Electric Biopsy Forceps	Stryker Sustainability Solutions	NON	Class I	2005-01-25
K042578	I-Promotions Contact Lens Case	I-Promotions, Inc.	LRX	Class II	2005-01-25
K042160	Sonosurg Trocar	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LFL	Unclassified	2005-01-25
K041642	V.a.c. Granufoam Silver Dressing	KCI USA, Inc.	OMP	Class II	2005-01-25
K040685	Z - Series Modular Total Hip System Plasma Coated	Osteoimplant Technology, Inc.	LWJ	Class II	2005-01-25
K043396	Integrity, Model V500	Vivosonic Inc.	GWJ	Class II	2005-01-24
K043375	Fisch Titanium Middle Ear Prostheses	Karl Storz Endoscopy-America, Inc.	ETA	Class II	2005-01-24
K043118	Hydrogum Soft	Zhermack S.p.A.	ELW	Class II	2005-01-24
K042924	Architect Stat Myo Immunoassay	Fisher Diagnostics	DDR	Class II	2005-01-24
K043582	Ocean Chest Drain	Atrium Medical Corporation	KDQ	Class II	2005-01-21
K043560	Periarticular Locking Plates and Screws, Series 2358 and 2359	Zimmer GmbH	HRS	Class II	2005-01-21
K043549	Infinity Gateway Suite, Vf4	Draeger Medical Systems, Inc.	MHX	Class II	2005-01-21
K043534	Modification to Outback Catheter	Lumend, Inc.	DQY	Class II	2005-01-21
K043514	Allogran-N-Bone Void Filler	Biocomposites, Ltd.	MQV	Class II	2005-01-21
K043415	Centricity Pacs System	GE Medical Systems Information Technologies, Inc.	LLZ	Class II	2005-01-21
K043389	Bd Phoenix Automated Microbiology System -Ampicillin-Sulbactam (Gn) 0.5/0.25-32/16Ug/ml	Becton Dickinson & Co	LON	Class II	2005-01-21
K043336	Optistrand, Model 1032S	Ibt SA	KXK	Class II	2005-01-21
K043271	R2-MRI Analysis System	Inner Vision Biometrics Pty, Ltd.	LNH	Class II	2005-01-21
K043206	Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQP	Class II	2005-01-21
K043113	Tempfix External Fixation System, Mr Safe	Depuy Orthopaedics Inc.	KTT	Class II	2005-01-21
K043102	Multi-Use Compression Screw	Wrightmedicaltechnologyinc	HWC	Class II	2005-01-21
K042885	Oct-Opthalmoscope	Ophthalmic Technologies, Inc.	HLI	Class II	2005-01-21
K042774	Mallory-Head Modular Calcar Stems with Interlocking Slots	Zimmer GmbH	LPH	Class II	2005-01-21
K042487	Procedur Sf Safety Syringe Device	Avanca Medical Devices, Inc.	MEG	Class II	2005-01-21
K042486	Procedur 10 Syringe Device	Avanca Medical Devices, Inc.	FMF	Class II	2005-01-21
K042315	Cerebral State Monitor - Csm	Danmeter A/S	OLW	Class II	2005-01-21
K042082	Airstrip Ob	Mp4 Solutions, LP	HGM	Class II	2005-01-21
K041920	Infinity Plus Electrotherapy System	Empi	IPF	Class II	2005-01-21