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 912 of 3530

510(k) clearances, page 912 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113790	Disposable Vinyl Exam Glove, Powdered	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-03-06
K113686	Kimono Microthin with Aqua Lube, Reality Ultra Lubricated	Mayer Laboratories	HIS	Class II	2012-03-06
K113464	Nc Trek Otw Coronary Dilatation Catheter	Abbott Vascular	LOX	Class II	2012-03-06
K113356	Hologic Visceral Fat Software	Hologic, Inc.	KGI	Class II	2012-03-06
K113274	Footprint Ultra Pk Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2012-03-06
K112606	Activator V-E	Activator Methods International Ltd.	LXM	Unclassified	2012-03-06
K112547	Neo Nest	Denovo Proucts, LLC	IMD	Class I	2012-03-06
K111268	Contour (R) Next Blood Glucose Monitoring System	Medrad, Inc.	LFR	Class II	2012-03-06
K113750	Disposable Powder Free Vinyl Exam Glove, White Color	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-03-05
K113711	Lime-Lite II	Pulpdent Corporation	EJK	Class II	2012-03-05
K113655	Ti-Max X Turbine	Nakanishi Inc.	EFB	Class I	2012-03-05
K113478	Plif Cage	Eisertech, LLC	MAX	Class II	2012-03-05
K113422	Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle	Terumo (Philippines) Corporation	FMI	Class II	2012-03-05
K111869	Virtuoso System for Ihc Pr (Ie2)	Ventana Medical Systems Inc	NQN	Class II	2012-03-05
K111792	Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini	Signus Medizintechnik GmbH	MAX	Class II	2012-03-05
K110901	Symbiq Infusion and Adminstration Set	Abbott Medical	FRN	Class II	2012-03-05
K120274	Deltamaxx 18 Microcoil System	Cerenovus, Inc.	HCG	Class II	2012-03-02
K113797	Disposable Vinyl Exam Glove, Powder Free	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-03-02
K113784	3Mp Monochrome Lcd Monitor, Radiforce Gx340	Eizo Nanao Corporation	LLZ	Class II	2012-03-02
K113617	Spee-Dee Patch	Pulpdent Corporation	EBF	Class II	2012-03-02
K113594	C-Thv System	Paieon, Inc.	IZI	Class II	2012-03-02
K113584	Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver	Abbott Medical	DXO	Class II	2012-03-02
K113455	Solitaire Fr Revascularization Device	Micro Therapeutics dba Ev3 Neurovascular	NRY	Class II	2012-03-02
K113297	Knotilus Anchor System	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2012-03-02
K113264	Electro Sensor Complex Software (Es Complex Software)	LD Technology LLC	DXN	Class II	2012-03-02
K113097	Laser Helmet	Theradome, Inc.	OAP	Class II	2012-03-02
K113095	E-Care Infrared Ear Thermometer	E-Care Technology Corporation	FLL	Class II	2012-03-02
K111964	Audit Microcv Urine/fluids Chemistry Linearity	Aalto Scientific Ltd.	JJY	Class I	2012-03-02
K111670	Venus Freeze (Mp)2 System	Venus Concept Inc.	GEI	Class II	2012-03-02
K111544	Glider Ptca Balloon Catheter	Trireme Medical, Inc.	LOX	Class II	2012-03-02
K111423	Cs 1600 Intraoral Camera	Eastman Kodak Company	NBL	Class II	2012-03-02
K110745	Helicobacter Pylori Elisa Igg Test Kit	Gold Standard Diagnostics, LLC	LYR	Class I	2012-03-02
K103081	Covaortho-Nerve Resorbable Collagen Membrane	Biom'Up SAS	JXI	Class II	2012-03-02
K120304	Footprint Medical Polyurethane Umbilical Catheter	Footprint Medical Inc.	FOS	Class II	2012-03-01
K113569	Apnearx	Apnea Science Corporation	LRK	Class II	2012-03-01
K113249	Transport Culture Medium Device	Puritan Medical Products Company, LLC	JSM	Class I	2012-03-01
K113238	Full Automatic (Nibp) Blood Pressue Monitor	Health & Life Corporation	DXN	Class II	2012-03-01
K113232	Maxmixing Block	Maxtec, LLC	BZR	Class II	2012-03-01
K113188	Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/sonolong	Pajunk GmbH Medizintechnologie	CAZ	Class II	2012-03-01
K113037	Pain-Aid	Pdi Works, LLC	NUH	Class II	2012-03-01
K113003	Atlantis(tm) Abutment and Atlantis(tm) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini(tm) Abutment...	Astra Tech, Inc.	NHA	Class II	2012-03-01
K112769	Curad Compression Hosiery	MEDLINE INDUSTRIES, LP - Northfield	DWL	Class II	2012-03-01
K112568	Aongen Dental Collagen Matrix	Aeon Astron Europe B.V.	OLR	Unclassified	2012-03-01
K112507	Restoris Partial Knee Application (Pka), Rio Standard System	Mako Surgical Corp.	OLO	Class II	2012-03-01
K112133	Oasys Surgical Light Controller	Oasys Healthcare Corporation	FTA	Class II	2012-03-01
K111947	Duet Magna	Direx Systems Corp.	LNS	Class II	2012-03-01
K111841	Shifeng Disposable Syringe with or without Needle	Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.	FMF	Class II	2012-03-01
K111654	Fd TENS 2070	FUJI Dynamics Limited	GZJ	Class II	2012-03-01
K111426	Euclid (Tm) Tier 1-Gw Access System	Houston Medical Robotics	ITX	Class II	2012-03-01
K120293	Spineology Peek Lumbar Interbody Fusion Drive	Spineology, Inc.	MAX	Class II	2012-02-29