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 2126 of 3531

510(k) clearances, page 2126 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K946171	Video Endoscope System with Zoom	Oktas	GCJ	Class II	1995-01-26
K946137	Pulpdent Periodontal Dressings	Pulpdent Corporation	EMA	Class II	1995-01-26
K946027	Big Phil	Biomedical Waste Systems, Inc.	FMI	Class II	1995-01-26
K945248	Hukuba Hyg Electric Ionic Toothbrush	Hukuba Dental Corp.	JEQ	Class I	1995-01-26
K945225	Disposable Syringes and Disposable Needles	Myco Medical Supplies Inc	FMF	Class II	1995-01-26
K945179	Bottle Collection Set	Medgyn Products, Inc.	HGF	Class II	1995-01-26
K944771	Intrascan II	Markcare Medical Systems, Inc.	LMD	Class I	1995-01-26
K944656	Optus Sinuscopes and Accessories	Optus, Inc.	EOB	Class II	1995-01-26
K944619	I.v.i.d. Fluid Administration Set Marker	Advanced Bioresearch Assoc.	FPA	Class II	1995-01-26
K944425	Ultrasafe Aspirating Syringe	Safety Syringes, Inc.	MEG	Class II	1995-01-26
K944268	Cit Two Way Suctin and Irrigation Tubes	Chirurgische Instrumente	HET	Class II	1995-01-26
K944183	Tru-Touch Medical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1995-01-26
K943810	Imagyn Microlap Introducer	Imagyn Medical, Inc.	HET	Class II	1995-01-26
K943277	Link Saddle Prothesis	Turnkey Intergration USA, Inc.			1995-01-26
K941915	Oral Steel Cartridge Syringe	Robert W. Bauer & Assoc., Inc.	EJI	Class II	1995-01-26
K941864	Mrt-150A, Mrt-150A Software Version 11.9	Toshiba America Mri, Inc.	LNH	Class II	1995-01-26
K941622	Echo Planar Imaging Option for the Magnetom Vision	Siemens Medical Solutions USA, Inc.	LNH	Class II	1995-01-26
K941031	Tohp-Cap	Jrm Ent., Inc.	FMI	Class II	1995-01-26
K932394	Bernstein(tm) Uterine Manipulator	Gm Engineering, Inc.	LKF	Class II	1995-01-26
K946000	Abuscreen Online(r) Calibrators	Roche Diagnostic Systems, Inc.	DKJ	Class II	1995-01-25
K945829	Microline Screen for Benzodiazepine	Drug Screening Systems, Inc.	JXM	Class II	1995-01-25
K945788	Karl Storz Rigid Telescopes for ENT Endoscopic Procedures	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1995-01-25
K945692	Monoclonal Mouse Anti-Human T-Cell, Cd2, Clone Mt910 Fitc-Conjugated, (Anti-Cd2,fitc, Mt910)	Dako Corp.	GKZ	Class II	1995-01-25
K945431	Model 792 Converge, Model 793 Vision 2000	Hausted, Inc.	FPO	Class II	1995-01-25
K944773	Model 405Ge-64: Phased Array Tmj Coil	Medical Advances, Inc.	LNH	Class II	1995-01-25
K944662	Flexart Qd Body Coil	Toshiba America Mri, Inc.	LNH	Class II	1995-01-25
K944469	General Purpose Flex Coil	Philips North America LLC	LNH	Class II	1995-01-25
K944331	Model 528Ge Series	Medical Advances, Inc.	LNH	Class II	1995-01-25
K944131	Anatom 2000	Analogic Corp.	JAK	Class II	1995-01-25
K943999	Abuscreen Ontrak Positive Control	Roche Diagnostic Systems, Inc.	DIF	Class I	1995-01-25
K943982	Il Test Gentamicin Calibrators	Instrumentation Laboratory Co.	LCD	Class II	1995-01-25
K943969	Model 578 Mobile Surgical Stretcher	Hausted, Inc.	FPO	Class II	1995-01-25
K942687	Il Test Carbamazepine, Pn 181754-00; Il Test Carbamazepine Calibrators, Pn 181762-00	Instrumentation Laboratory Co.	KLT	Class II	1995-01-25
K941458	Uterine Manipulator/injector with Spring	Zinnanti Surgical Instruments, Inc.	LKF	Class II	1995-01-25
K934139	Tomtec Echo-View	Tomtec Tomographic Technologies GmbH	IYO	Class II	1995-01-25
K933818	Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter	C.G.H. Medical, Inc.	KDI	Class II	1995-01-25
K946326	Dutex Gauze Bandage	Dumex Medical Surgical Products, Ltd.	EFQ	Unclassified	1995-01-24
K946162	3M(tm) Surgical Slipper, 9660 Series	Wahl Clipper Corp	LWK	Class I	1995-01-24
K946146	Cardiospex(tm) Liquid Ckmb/ld-1 Immunoinhibition	Clinical Controls, Inc.	JJT	Class I	1995-01-24
K946145	Cardiospex(tm) Ckmb/ld-1 Immunoinhibition Control	Clinical Controls, Inc.	JJT	Class I	1995-01-24
K946012	Precision Uv(tm) (Vasurficon a)	Pilkington Barnes-Hind, Ltd.	LPL	Class II	1995-01-24
K945701	Surgilene(r) Sutures	Davis & Geck, Inc.	GAW	Class II	1995-01-24
K945607	Varelisa M2 Antibodies	Elias U.S.A., Inc.	DBM	Class II	1995-01-24
K945576	Meadox Surgimed Noprofile(tm) Olbert Catheter System(r)	Meadox Medicals, Div. Boston Scientific Corp.	EZN	Class II	1995-01-24
K945259	Dateminder Contact Lens Case	Bruce A. Berkley	LRX	Class II	1995-01-24
K945182	Dyonics Fixation Screws	Smith & Nephew Dyonics, Inc.	HWC	Class II	1995-01-24
K945100	Karl Storz Suction/irrigation Tubes, Cannulae	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-01-24
K944842	Arthroscope	5 Star Medical, Inc.	HRX	Class II	1995-01-24
K944793	Karl Storz Monopolar Coagulation, Needle, Loop Electrodes	Karl Storz Endoscopy-America, Inc.	KNF	Class II	1995-01-24
K944269	Cit Grasping and Dissecting Forceps	Chirurgische Instrumente	HET	Class II	1995-01-24