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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3518 of 3526

510(k) clearances, page 3518 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760577	Richards Clavicle Strap	Richard'S Medical Equip., Inc.	IQJ	Class I	1976-10-06
K760575	Rocker-Sole Cast Sandal	Richard'S Medical Equip., Inc.	IPG	Class I	1976-10-06
K760574	Economy Immobilization and Velpean Sling	Richard'S Medical Equip., Inc.	ILI	Class I	1976-10-06
K760264	Curette, Proposed Tis-U-Trap, Metal	Milex Products, Inc.	HHK	Class II	1976-10-06
K760741	Portable X-Ray	Minxray Inc	IZL	Class II	1976-10-05
K760726	Electro-Keratotome, Line-Operated	Storz Instrument Co.	HNO	Class I	1976-10-05
K760707	Ritter Starlight Dental Operating Light	Ritter GmbH	EAZ	Class I	1976-10-05
K760705	Oxygen-Rich	The John Bunn Co.	CAW	Class II	1976-10-05
K760704	Oxygen-Rich	Xorbox	CAW	Class II	1976-10-05
K760689	Nervel-Nerve Conduction Velocity Meter	Bak Electronics	JXE	Class II	1976-10-05
K760688	Ct/n-II Scanner System	General Electric Co.	JAK	Class II	1976-10-05
K760684	Visc X-Vitreous Aspirating & Cut. Instr	Varian Assoc., Inc.	HKP	Class II	1976-10-05
K760677	Lifepak 5 Cardioscope Module (Npn 5)	Physio Control, Inc.	DPS	Class II	1976-10-05
K760664	Crawford Portavac	Crawford Electric			1976-10-05
K760655	Aneroid Sphygmomanometer	Abco Dealers, Inc.	DXQ	Class II	1976-10-05
K760651	Total Hip Replacement,lagrange-Letournel	Orthopedic Equipment Co., Inc.	JDG	Class II	1976-10-05
K760649	Total Spinal Correction	Depuy, Inc.	JDN	Class II	1976-10-05
K760636	Orthomix	Diemolding Corp.	JDZ	Class I	1976-10-05
K760621	Lancer Plastic Transfer Pipette	Sherwood Medical Industries	JRC	Class I	1976-10-05
K760617	Mix Evac Bone Cement	Stryker Corp.	JDZ	Class I	1976-10-05
K760605	Lightcast II Carbide Blade	Merck, Sharp & Dohme	GES	Class I	1976-10-05
K760576	Tourniwrap Bandage	Richard'S Medical Equip., Inc.	ILG	Class I	1976-10-05
K760573	Improved Knee Dressing	Richard'S Medical Equip., Inc.	ITM	Class I	1976-10-05
K760550	Implant, Silicone and Tantalum	Medical Instrument Research Assoc., Inc.	HQJ	Class II	1976-10-05
K760437	Causse Modified Teflon Piston, Otology	Richard'S Medical Equip., Inc.	ETB	Class II	1976-10-05
K760434	Trapeze Platinum Ribbon Loop, Otology	Richard'S Medical Equip., Inc.	ETB	Class II	1976-10-05
K760433	Shea Torp, Otology Implant	Richard'S Medical Equip., Inc.	ETA	Class II	1976-10-05
K760355	Test, Serosonic Albumin	Mallinckrodt Critical Care	CIX	Class II	1976-10-05
K760349	Bilirubin Ref., Sigma Stock No. 605-10	Sigma Chemical Co.	JIT	Class II	1976-10-05
K760347	Set, Trinder Glucose	Princeton Biomedix	CGA	Class II	1976-10-05
K760201	X-Ray Scanner, Computerized Tomographic	American Science and Engineering, Inc.	JAK	Class II	1976-10-05
K760008	Dental Material, Implant, High-Purity Al	Kyocera International, Inc.	DZE	Class II	1976-10-05
K760583	Disposable/borosilicate Culture Tubes	BD Becton Dickinson Vacutainer Systems Preanalytic			1976-10-03
K760329	Mask, Disposable Oxygen Therapy	Inhal-O-Tech Medical Plastic	BYG	Class I	1976-09-30
K760320	Protector, Surgical Instrument	Devon Industries, Inc.	KCT	Class II	1976-09-30
K760683	Alarm, Thermal, Therm-Alert	Respiratory Care, Inc.	KPD	Class II	1976-09-27
K760680	Intermittent Mandatory Ventilation	B & F Medical Products, Inc.	CBO	Class II	1976-09-27
K760668	Selectatec System	Medishield, Inc.	CAD	Class II	1976-09-27
K760663	Mvp-10 Pediatric/neonatal Ventilator	Air-Shields, Inc.	CBK	Class II	1976-09-27
K760660	Hydrol	Septodont	LBH	Class II	1976-09-27
K760659	Calcipulpe	Septodont	EJK	Class II	1976-09-27
K760658	Detartrine P	Septodont	EJR	Class I	1976-09-27
K760657	Racestyptine Cord	Septodont	EIG	Class I	1976-09-27
K760656	Detartrine Z	Mr. J. Garrick Eisenberg	EJR	Class I	1976-09-27
K760623	Lancer Paraplast Histo Process Cassette	Sherwood Medical Industries	IDZ	Class I	1976-09-27
K760578	Balanced Cast Sole	Parke-Davis Co.	IPG	Class I	1976-09-27
K760503	Stimulator, Electrical Muscle (#Md-8)	R. A. Fischer Co. Corp.	IPF	Class II	1976-09-27
K760439	Plasti-Pore Bobbin Drain Tube, Otology	Richard'S Medical Equip., Inc.	ETD	Class II	1976-09-27
K760435	Piston, Platinum Teflon, Otology Implant	Richard'S Medical Equip., Inc.	ETB	Class II	1976-09-27
K760261	Detector, Model Lc-100 Fluorescence	Revvity Health Sciences, Inc.	KHO	Class I	1976-09-27