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 2429 of 3531

510(k) clearances, page 2429 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912945	Satin Prophylaxis Paste	Dentsply Intl.	EJR	Class I	1991-09-16
K912696	Trauma View Rad Syst Model #B-Trv/stret Mobil Tabl	Bennett X-Ray Corp.	IYB	Class I	1991-09-16
K912686	Whiter Biter Crown	George M. Wilson, Dds	ELZ	Class I	1991-09-16
K912669	Resound Portable Prescriptive Programming System	Resound Corp.	EWO	Class II	1991-09-16
K912663	Natural-Knee Ultra Congruent Tibial Insert	Intermedics Orthopedics	JWH	Class II	1991-09-16
K912656	Endoscopic Electrode	Applied Urology, Inc.	GEI	Class II	1991-09-16
K912644	Cordis Inflator Device	Cordis US Corp.	MAV	Class II	1991-09-16
K912558	Gull Elisaware	Gull Laboratories, Inc.	LIB	Class I	1991-09-16
K912474	Classic 4-Way Elevating Table	Continental X-Ray Corp.	IZZ	Class II	1991-09-16
K912442	Quidel Helicobacter Pylori Microwell Eia Test	Ortho-Clinical Diagnostics, Inc.	LYR	Class I	1991-09-16
K911732	Advance Disposable Control Syringe	Advance Medical Designs Inc	IZI	Class II	1991-09-16
K911433	Right-Angle Catheter for Ventricular Drainage	Cordis US Corp.	JXG	Class II	1991-09-16
K911208	Tin Coated Dental Burs	Surgical Precision Instruments, Corp.	EJL	Class I	1991-09-16
K911131	Sterile Surgical Gown Pack	Central Georgia Ancillary Health Systems	KKX	Class II	1991-09-16
K910757	The Bullion	Octostop, Inc.	KPR	Class II	1991-09-16
K905819	Medrad Varible Infusion Injector	Medrad, Inc.	DXT	Class II	1991-09-16
K913615	Urinary/csf Protein	Boehringer Mannheim Corp.	JGQ	Class II	1991-09-13
K913446	Ican Needle Counters	Icn Pharmaceuticals, Inc.	MMK	Class II	1991-09-13
K913311	Safety Injection Port, Modification	Riverside Technology, Inc.	FPA	Class II	1991-09-13
K913309	Tdm I Linearity Test Set	Casco Standards	DIF	Class I	1991-09-13
K913154	Ohmeda - Ohio Car Plus Incubator, Modification	GE Healthcare	FMZ	Class II	1991-09-13
K913070	X-L (Dw228-14A) and X-Lx (Dw228-24A)	Ivoclar North America, Inc.	EJS	Class II	1991-09-13
K912971	Intherm Radially Expanding Dilater	Interventional Therapeutics Corp.	FGE	Class II	1991-09-13
K912655	Minimax Oxygenation System	Medtronic, Inc.	DTZ	Class II	1991-09-13
K912645	Atriums Pdr Thoracic Catheter	Atrium Medical Corporation	GBS	Class I	1991-09-13
K912628	Air Argon Ion Lasers Various Models	Hgm Medical Laser Systems, Inc.	GEX	Class II	1991-09-13
K911626	System 9000, Interpretive Diff Cell Counter	Serono Baker Diagnostics System	GKZ	Class II	1991-09-13
K911079	Amb-Alert	Medway	KMI	Class I	1991-09-13
K910881	Control and Linearity	Gds Diagnostics	DKB	Class II	1991-09-13
K910475	Dental Needle Protective System	Health Technology Systems, Inc.	DZM	Class I	1991-09-13
K910438	Dipstick Salmonella	Ampcor, Inc.	GRM	Class II	1991-09-13
K912634	Cordless Electric Massager Ev315	Matsushita Electric Co.	ISA	Class I	1991-09-12
K913858	Amylase Reagent (Procedure 577)	Sigma Diagnostics, Inc.	JFJ	Class II	1991-09-11
K913563	Magnetic Resonance Diagnostic Device Accessoriy	Siemens Medical Solutions USA, Inc.	LNH	Class II	1991-09-11
K913513	Lateralase Sterile Disposable Fiber	Heraeus Lasersonics, Inc.	GEX	Class II	1991-09-11
K913496	Cholinesterase Linearity Control	Creative Laboratory Products, Inc.	JJX	Class I	1991-09-11
K913295	Opus(r) Plus Analyzer	Pb Diagnostic Systems, Inc.	JJQ	Class I	1991-09-11
K913207	Triflex(r) Powder Free Sterile Surgeon's Glove	Baxter Healthcare Corporation	KGO	Class I	1991-09-11
K913049	Slip-Pruf-Clinger	Macbrud Corp. Medical Div.	KDD	Class I	1991-09-11
K912961	Morse Vascular Introducer Set	North American Instrument Corp.	DYB	Class II	1991-09-11
K912878	Open Ended Guidewire	Lake Region Mfg., Inc.	DQX	Class II	1991-09-11
K912806	Abbott Quickstart Bicarbonate Test CO2 Item# 5A22	Em Diagnostic Systems, Inc.	KHS	Class II	1991-09-11
K912722	Hyper-K Heat System	Baxter Healthcare Corporation	ILO	Class II	1991-09-11
K912709	Mx 339 Twin Hemostatic Y Connector	Medex, Inc.	DTL	Class II	1991-09-11
K912700	Flocare Dry Cas Sampling Port Models	Flocare Medical	BYD	Class I	1991-09-11
K912699	Flocare Lf-a	Flocare Medical	BYD	Class I	1991-09-11
K912599	Quik-Pace(r) or Ex-Pace(tm) Pediatric Pacing Elec	Physio Control, Inc.	DRO	Class II	1991-09-11
K912578	20Cm/h20 PEEP Valve	Vital Signs, Inc.	BYE	Class II	1991-09-11
K912561	Nova 13 Analyzer	Nova Biomedical Corporation	CGZ	Class II	1991-09-11
K912368	Imx Select Analyzer	Abbott Medical	JJQ	Class I	1991-09-11