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 2562 of 3530

510(k) clearances, page 2562 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900090	Nikon Multi-Sport Sunglasses	Oculus America	HQY	Class I	1990-03-12
K897186	Laser Imaging Work Station	Innovision Medical, Inc.	HJI	Class I	1990-03-12
K897107	Poly G Physiological Data Recorder	Cns, Inc.	BXO	Class I	1990-03-12
K897059	Hood Speaking Valve	Hood Laboratories	JOH	Class II	1990-03-12
K896923	Intertech/inspiron (R) Medication Nebulizer Kit	Intertech Resources, Inc.	CAF	Class II	1990-03-12
K895915	Meritec(tm) - C. Difficile Latex Test System	Meridian Diagnostics, Inc.	MCB	Class I	1990-03-12
K895159	Intravascular Imaging System	Intertherapy, Inc.	LYK	Class II	1990-03-12
K894650	Q-Port System Kit	Quinton, Inc.	LJT	Class II	1990-03-12
K884389	Modified 225/Simv Volume Ventilator	Monaghan Medical Corp.	CBK	Class II	1990-03-12
K900869	Non-Sterile Latex Procedure Glove	Sri Johani Sdn. Bhd.	LYY	Class I	1990-03-09
K900868	Sterile Latex Examination Glove	Sri Johani Sdn. Bhd.	LYY	Class I	1990-03-09
K900811	Latex Patient Examination Gloves	Kenwell International, Ltd.	LYY	Class I	1990-03-09
K900775	Novapath Sp Advanced Liquid Handling System	Bio-Rad	JQW	Class I	1990-03-09
K900728	Mrt 50A Knee Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900727	Mrt 50A Joint Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900644	i.v. Freedom Clip	Infection Control Products, Inc.	FPA	Class II	1990-03-09
K900591	Vent-Trap Cat# Wr1000	Salter Labs	BYH	Class I	1990-03-09
K900484	Ret-Check	Streck Laboratories, Inc.	GJR	Class II	1990-03-09
K900289	Mrt 50A 100Mm Circular Surface Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900288	Mrt 50A Brain Qd Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900285	Mrt 50A Flexible Body Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900284	Mrt 50A 150Mm Circular Surface Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-03-09
K900203	Ez-Screen:opiates	Environmental Diagnostics, Inc.	DJG	Class II	1990-03-09
K900149	Powder-Free Vinyl Gloves	Good Glove Corp.	LYZ	Class I	1990-03-09
K900143	Abuscreen Fp for Methamphetamine	Roche Diagnostic Systems, Inc.	DKZ	Class II	1990-03-09
K900120	Roche Separating Reagent for Hdl Cholesterol	Roche Diagnostic Systems, Inc.	LBR	Class I	1990-03-09
K900064	Vista Hpq System, Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1990-03-09
K900036	Immunotech Hdl-Cholesterol Test	IMMUNOTECH s.r.o.	LBS	Class I	1990-03-09
K900013	Milenia (Tm) Digitoxin	Siemens Healthcare Diagnostics Inc.	LFM	Class II	1990-03-09
K897164	Coulter Ld (Ldh-L) Reagent	Coulter Electronics, Inc.	CFJ	Class II	1990-03-09
K897163	Coulter Alt (Gpt) Reagent	Coulter Electronics, Inc.	CKA	Class I	1990-03-09
K897160	Coulter Glucose Reagent	Coulter Electronics, Inc.	CFR	Class II	1990-03-09
K897159	Coulter Triglycerides Gpo Reagent	Coulter Electronics, Inc.	CDT	Class I	1990-03-09
K897138	Affinity(tm) Htsh(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1990-03-09
K897071	Roche Standards for the Cobas Ise Module	Roche Diagnostic Systems, Inc.	JIX	Class II	1990-03-09
K897001	Tosoh Aia-Pack T3	Tosoh Corp.	CDP	Class II	1990-03-09
K896984	Pari I.s.-2	Dura Pharmaceuticals, Inc.	CAF	Class II	1990-03-09
K896982	Aia-Pack T4	Tosoh Corp.	KLI	Class II	1990-03-09
K896359	Ag-820Pa Fi02 Module	Nihon Kohden America Inc	CCL	Class II	1990-03-09
K896146	Biopsy Forceps, (Non-Rigid)	Portlyn Corp.	EOQ	Class II	1990-03-09
K895781	Ansell E.p. Extra-Protection Examination Gloves	Ansell Intl.	LZC	Class I	1990-03-09
K895479	Thayer Semi-Rigid Condensate Collection System	Thayer Medical Corportation	BYH	Class I	1990-03-09
K895328	Magnetic Resonance System Model Bmt-1100	Bruker Medical Imaging, Inc.	LNH	Class II	1990-03-09
K894629	Nicolet Beam II System	Nicolet Instrument Corp.	GWS	Class I	1990-03-09
K893606	Patient Examination Gloves	Aukland Mfg., Inc.	LZA	Class I	1990-03-09
K900691	Biodyne Instrument Wipes	Bio-Dyne, Inc.	GEC	Class I	1990-03-08
K900654	Modified Captia(r) Syphilis-M	Mercia Diagnostics, Ltd.	LIP	Class II	1990-03-08
K900650	Latex Examination Gloves	Shenzhen Guang JI Emulsion Products Co., Ltd.	LYY	Class I	1990-03-08
K900648	Nil Sterile Latex Examination Gloves	United Lion Rubber Industries Sdn. Bhd.	LYY	Class I	1990-03-08
K900499	Latex Patient Examination Gloves	Premium Fit	LYY	Class I	1990-03-08