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 2340 of 3531

510(k) clearances, page 2340 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923505	Ast (Got) - Aspartate Aminotransferase	Randox Laboratories, Limited	CIT	Class II	1992-11-16
K922976	Lb 9502- Clinilumat, Lb 953 - Auto-Climilumat	Eg&G Berthold Analytical Instruments, Inc.	JJQ	Class I	1992-11-16
K922934	Enzygnost F 1+2	Behring Diagnostics, Inc.	MIF	Class II	1992-11-16
K922881	Clarus Models 1100, 1101, 1102, 1103 Laser Disc	Clarus Medical Systems, Inc.	GEX	Class II	1992-11-16
K922858	Multidraw System	Cambridge Multi-Draw, Inc.	GIM	Class II	1992-11-16
K922529	Powered Muscle Stimulator	M.S.P., Ltd.	LIH	Class II	1992-11-16
K922520	Modified Tsrh Central Post Hooks	Sofamor Danek Mfg., Inc.	KWP	Class II	1992-11-16
K922507	Gerson Isolair Apr Particulate Surgical Mask	Louis M. Gerson Co., Inc.	FXX	Class II	1992-11-16
K922329	Berthold Lb 954	Eg&G Berthold Analytical Instruments, Inc.	JJQ	Class I	1992-11-16
K921705	Ultrasonic Pachymeter	Precision Corneal Instruments	IYO	Class II	1992-11-16
K921414	Trokel /3 Gonio Laser Lens	Ocular Instruments, Inc.	LQJ	Class II	1992-11-16
K915725	Clarus Models 1230 and 1231 Laparo-Needle	Clarus Medical Systems, Inc.	FHO	Class II	1992-11-16
K914920	Biofeedback System/3	Davicon, Inc.	HCC	Class II	1992-11-16
K914397	Oxford Optronix Mpm 3S	Dia-Stron, Ltd.	FTI	Class II	1992-11-16
K911349	E-Z-Em Enteroclysis Catheter Set	E-Z-EM, Inc	EZK	Class II	1992-11-16
K914334	Alcon(r) Fx2(tm) Photocoagulator	Alcon Laboratories	GEX	Class II	1992-11-13
K924276	Short Tegwire -- Modified	Boston Scientific Corporation	LIT	Class II	1992-11-10
K922927	Mortara Instrument St Central Station	Mortara Instrument, Inc.	DPS	Class II	1992-11-10
K922631	Statpal II Blood Gas Analysis System	Ppg Industries, Inc.	CHL	Class II	1992-11-10
K921940	Mrt-35(Tm)	Toshiba America Mri, Inc.	LNH	Class II	1992-11-10
K921845	Insyte Artcath Arterial Catheterization Unit	Becton Dickinson Vascular Access, Inc.	DQO	Class II	1992-11-10
K921289	Inman Medical Petrolatum Dressing	Inman Medical Corp.	FRO	Unclassified	1992-11-10
K920002	Model 7200Ae Ventilator Flow by 2.0 or Option 50	Medtronic, Inc.	CBK	Class II	1992-11-10
K915730	Mortara Instrument Odel Eli 50I	Mortara Instrument, Inc.	LOS		1992-11-10
K915209	Malecot-Nephrostomy Tamponade Catheter	Cook Incorporated	LJE	Unclassified	1992-11-10
K924574	Emds Alkaline Phosphatase (Alp) Test	Em Diagnostic Systems, Inc.	CJE	Class II	1992-11-09
K924427	Synermed Hdl Cholestlerol Reagent Kit	Synermed, Inc.	LBR	Class I	1992-11-09
K924241	Argenco 75M	Argen Precious Metals, Inc.	EJT	Class II	1992-11-09
K924081	Lumisonic	Lumiscope Co., Inc.	CAF	Class II	1992-11-09
K924002	Midland Three Section P.t. Table W/ Drainage	Midland Mfg. Co.	INQ	Class I	1992-11-09
K923998	Midland Tilt Table	Midland Mfg. Co.	INQ	Class I	1992-11-09
K923973	Space Base Electric Tilt Table	Midland Mfg. Co.	INQ	Class I	1992-11-09
K923830	Xomed-Treace Alphascope	Xomed-Treace, Inc.	ERA	Class I	1992-11-09
K923807	P.f.c. Modular Total Knee System, Modular Plus	Johnson & Johnson International	JWH	Class II	1992-11-09
K923647	Rfg-Dgp Disposable Grounding Pads	Radionics, Inc.	JOT	Class II	1992-11-09
K923617	Full Movement Therapy Systems	Arjo-Century, Inc.	ILJ	Class II	1992-11-09
K923494	Paramed Lateral Flexion Machine	Paramed Div	BXB	Class I	1992-11-09
K923103	Jt-1 Powered Traction Unit	Chirotronics, Inc.	ITH	Class II	1992-11-09
K923042	Du Pont Linx Hd-25 Lasr Imager	E.I. Dupont de Nemours & Co., Inc.	LLZ	Class II	1992-11-09
K922636	Hemo-Stat	Mckinley-Ross Laboratories, Inc.	SEJ	Unclassified	1992-11-09
K921941	Signa Advantage 0.5T Mag Reson Sys-Fast Acquis Opt	General Electric Co.	LNH	Class II	1992-11-09
K921194	Hewlett-Packard Cardiac Catheterization Recording	Hewlett-Packard Co.	DRT	Class II	1992-11-09
K921044	Alpha-Dent Orthodontic Adhesive with One Step Bond	Wallace A. Erickson & Co.	DYH	Class II	1992-11-09
K915647	Diagnostic Ultrasound System Model Sc250	Pie Medical Equipment B.V.	ITX	Class II	1992-11-09
K913890	Sonicath(tm) 3.5 F, 20 Mhz	Boston Scientific Corporation	ITX	Class II	1992-11-09
K911529	Bunny Electrode/stealth Electrode Pre Wired EEG	Lead-Lok, Inc.	DRX	Class II	1992-11-09
K911518	Bunny Electrode/stealth Solid Gel-Snap on Foam	Lead-Lok, Inc.	DRX	Class II	1992-11-09
K925103	Aahs Hearing Aid	American Hearing Systems, Inc.	ESD	Class I	1992-11-06
K924864	Nova 13 Analyzer, Modification	Nova Biomedical Corporation	CGZ	Class II	1992-11-06
K924743	Nova 12 Analyzer, Modification	Nova Biomedical Corporation	CGA	Class II	1992-11-06