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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2906 of 3529

510(k) clearances, page 2906 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K855210	Surgical Carbon Dioxide Laser Sys. #20B Ultralight	Directed Energy, Inc.	GEX	Class II	1986-05-02
K854998	Surgical CO2 Laser System #20/Optical for Arthrosc	Directed Energy, Inc.	GEX	Class II	1986-05-02
K854901	Pacific Grasper	Euro-Med Intl.	KDC	Class I	1986-05-02
K854898	Atlantic Grasper	Euro-Med Intl.	KDC	Class I	1986-05-02
K854897	Max-I-Grasp	Euro-Med Intl.	KDC	Class I	1986-05-02
K854896	Hook Scissor	Euro-Med Intl.	KDC	Class I	1986-05-02
K854895	Basket Forcep	Euro-Med Intl.	KDC	Class I	1986-05-02
K854894	Spoon	Euro-Med Intl.	KDC	Class I	1986-05-02
K854891	Knife	Euro-Med Intl.	EMF	Class I	1986-05-02
K854890	Hook Probe	Euro-Med Intl.	KDC	Class I	1986-05-02
K854231	Electrosurgical Cutting & Coagulation Device/acces	Clinical Technology Inc.	GEI	Class II	1986-05-02
K854194	Imt Ultrasonic Stride Monitor	Innovative Medical Technologies, Inc			1986-05-02
K853878	Endo-Lase Cd-100 CO2 Laser for Neurosurgery	Endo Lase, Inc.	GEX	Class II	1986-05-02
K852250	595 Arrhythmia Monitoring System	Burdick Corp.	DSI	Class II	1986-05-02
K861434	Modified Hc-417 Bag to Bag & Hc-418 Bottle to Bag	Churchill Corp.	LHI	Class II	1986-05-01
K861159	Spectro Vwf	Ramco Laboratories, Inc.	GGP	Class II	1986-05-01
K861010	Vma by Hplc Test (Vanilmandelic Acid)	Bio-Rad	CDF	Class I	1986-05-01
K860479	Green-Line Bipolar Coagulation Unit	Grieshaber & Co.	GEI	Class II	1986-05-01
K854705	Infaguard Tm	Lifewatch Systems, Inc.	BZQ	Class II	1986-05-01
K854618	Cordot R	Cordis US Corp.	LFX	Class II	1986-05-01
K854196	Dci Model Ep-2 Clinical Stimulator	Digital Cardiovascular Instruments, Inc.	DRO	Class II	1986-05-01
K853988	Foran Corp-Suresert Intravenous Catheter Place Uni	Foran Industries, Inc.	FOZ	Class II	1986-05-01
K861329	Isotrak Amylase Isoenzyme Control Set	Behring Diagnostics, Inc.	JJT	Class I	1986-04-30
K861265	Dialet Lancing Device	Home Diagnostics, Inc.	FMK	Class II	1986-04-30
K861196	Sterile Stockinette W/antimicrobial Agent	DeRoyal Industries, Inc.	KKX	Class II	1986-04-30
K861148	Bisco's Porcelain Veneer System	Bisco, Inc.	EBF	Class II	1986-04-30
K861084	Osteograf/ar Alveolar Rid Hydrox, 18-40 Mesh	Coors Biomedical Co.	LYC	Class II	1986-04-30
K861083	Osteograf/ar+(plus) Alveolar Rid Hydrox 18-40 Mesh	Coors Biomedical Co.	LYC	Class II	1986-04-30
K860811	Zeiss Voice Control System for Opmi's	Carl Zeiss, Inc.	EPT	Class I	1986-04-30
K860686	Faceglov,anesthetic Gas Mask	Loran, Ltd.	BSJ	Class I	1986-04-30
K860676	Heartstart 2000	First Medical Devices Corp.	MKJ	Class III	1986-04-30
K860551	Etp 180 Cardiac Pacemaker (External)	Biotronics Corp.	DRO	Class II	1986-04-30
K860471	Del Amr Model 250 Cardiodisplay Holter Scanner	Del Mar Avionics	DSI	Class II	1986-04-30
K860470	Del Mar Model 750 Innovator Holter Management Syst	Del Mar Avionics	DSI	Class II	1986-04-30
K860457	Electrocardiograph Continuous Monitor	Oxford Medilog, Inc.	GWN	Class II	1986-04-30
K854334	Painblocker Wa5000	CooperSurgical, Inc.	GXH	Class II	1986-04-30
K843247	Koi Pachymeter	Koi, Inc.	ITX	Class II	1986-04-30
K861243	Neonatal Unilet	Ulster Scientific, Inc.	FMK	Class II	1986-04-29
K861176	Model 366-20 Adaptaid Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1986-04-29
K861008	Percutaneous Catheters	Micor, Inc.	DQY	Class II	1986-04-29
K860984	Tandem Icon Lh Assay (Urine) Immunoenzymetric Kit	Hybritech, Inc.	CEP	Class I	1986-04-29
K860898	Subclavian Introducer Set	Infusaid Corp.	DYB	Class II	1986-04-29
K860834	Spacelabs Medical Workstation	Spacelabs, Inc.	DSI	Class II	1986-04-29
K860539	Sarns Oxygenator System	3M Health Care, Sarns	DTZ	Class II	1986-04-29
K860523	Cardio-Cool	Bio-Vascular, Inc.	DTR	Class II	1986-04-29
K860362	Silicath-Ag Silicone Elastomer Foley Catheter	Travenol Laboratories, S.A.	KNX	Class II	1986-04-29
K855201	Bard Parker Perfusion Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	DQY	Class II	1986-04-29
K854637	Lee Electronics Pal	Lee Electronics	ESD	Class I	1986-04-29
K861448	Quantimetrix Serum Lipid Control I & II Liquid	Quantimetrix Medical Industries	JJY	Class I	1986-04-28
K861419	Hi Chem Diagnostics Ldl Reagent Cartridge	Hi Chem, Inc.	CFJ	Class II	1986-04-28