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 2853 of 3529

510(k) clearances, page 2853 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864626	Cancellous Bone Screw	Dow Corning Wright	HWC	Class II	1986-12-15
K864574	Mac 150E Opthalmic Chair	Koken Mfg Company, Inc.	HME	Class I	1986-12-15
K864494	Model 6500 Opthalmic Chair	Koken Mfg Company, Inc.	HME	Class I	1986-12-15
K864476	Leg Holder	American Container Technology, Inc.	HRX	Class II	1986-12-15
K864467	Henson - Hamblin Cfs 2000 Central Field Screen	Keeler Instruments, Inc.	HOO	Class I	1986-12-15
K864379	Emerson 3Mv Volume Ventilator	J. H. Emerson Co.	CBK	Class II	1986-12-15
K864369	Lts Corneal Microscope Laser Tomographic Scanner	Heidelberg Instruments	HJB	Class I	1986-12-15
K864339	Porta Ray Model 325	Porta Ray, Inc.	IZO	Class I	1986-12-15
K864304	Yannuzzi Fundus Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1986-12-15
K864301	Site Phacoemulsification Syst/ophthalmic Use (Mod)	Site Microsurgical Systems, Inc.	HQC	Class II	1986-12-15
K864290	Rk-M & Rk-Dk Diamond Knives with Measuring Gauge	Keeler Instruments, Inc.	HNN	Class I	1986-12-15
K864275	Anti-Ndna Antibody Test Kit	Cappel Diagnostics, Inc.	KTL	Class II	1986-12-15
K864065	Bks-42 Disposable Vacuum Tubing Pack	Allergan	HNO	Class I	1986-12-15
K864043	Esophageal Stethoscope W/thermocouple Type T	Respiratory Support Products, Inc.	BZT	Class II	1986-12-15
K864035	Ves-10 Intraocular Scissors Drive	Trek Medical Products, Inc.	HQE	Class II	1986-12-15
K864034	Open Reservoir Scavenger	Draeger, Inc.	CBN	Class II	1986-12-15
K863978	Portable Liquid Oxygen Unit (Modification)	Penox Technologies, Inc.	BYJ	Class II	1986-12-15
K863933	Vis-Cube Hcg (Eia)	Leeco Diagnostics, Inc.	JHI	Class II	1986-12-15
K863746	Bird Nightbird Nasal CPAP System	Bird Products Corp.	BZD	Class II	1986-12-15
K863743	Biotech's Ige Immuno Response Test Isotope Unit	Immuno Nuclear Corp.	DHB	Class II	1986-12-15
K863613	No-Flo I	Design Technologies, Inc.	CCN	Class I	1986-12-15
K863134	Multispiro Sa/100	Biotrine Corp.	BZG	Class II	1986-12-15
K862017	Arthroscopic Shoulder Ligament Repair Kit	Dyonics, Inc.	HRX	Class II	1986-12-15
K861692	Fischer Pps/mammotest Mammography System	Fischer Imaging Corp.	IZH	Class II	1986-12-15
K864517	Model 504-S External Infusion Pump for Diabetics	Medtronic, Inc.	FRN	Class II	1986-12-12
K864425	Raylor(tm) Dissecting Hook	Cedar Surgical, Inc.	GDG	Class I	1986-12-12
K864015	Sterilabels	Diversatronics, Inc.	LDQ		1986-12-12
K864012	Iras Perimeter	Randwal Instrument Co., Inc.	HPJ	Class II	1986-12-12
K863997	Abbott Lifecare(r) 4100 Pca Infuser	Abbott Medical	FRN	Class II	1986-12-12
K863911	Mainster Retina Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1986-12-12
K863667	Modified Synatomic Knee Patella Prosthesis	Depuy, Inc.	JWH	Class II	1986-12-12
K863576	Eub-400 Diagnostic Ultrasound Device	Hitachi Medical Corp. of America	IYO	Class II	1986-12-12
K863368	Syph-Trust	I.A.F. Production, Inc.	GMQ	Class II	1986-12-12
K863079	Creatinkinetic	J. D. Assoc.	CGX	Class II	1986-12-12
K864666	Modified Lifestat 200	Physio Control, Inc.	DXN	Class II	1986-12-11
K864665	Modified Vsm 2 Vital Signs Monitor	Physio Control, Inc.	DXN	Class II	1986-12-11
K864442	Norfloxacin Susceptibility Powder	Merck, Sharp & Dohme	JTT	Class II	1986-12-11
K864187	Kotex (R) Goodnites	Kimberly-Clark Corporation	HHL	Class II	1986-12-11
K864179	Biologic 1000 Hemodialysis Mach/hd-1000 Disp Cartr	Ash Medical Systems, Inc.	FKT	Class II	1986-12-11
K864027	Bbl Campyslide(tm) Test	BD Becton Dickinson Vacutainer Systems Preanalytic	LQP	Class I	1986-12-11
K863960	Stockert-Shiley Caps Battery Module	Shiley, Inc.	DTQ	Class II	1986-12-11
K863902	Modified Sarns Membrane Oxygenator	3M Health Care, Sarns	DTX	Class II	1986-12-11
K863785	Makler Catheter	I M, Inc.	HDR	Class II	1986-12-11
K862153	Arrow 18Ga Two-Lumen Intravenous Cath/23ga Needle	Arrow Intl., Inc.	FOZ	Class II	1986-12-11
K862127	Dymax Personal Scanner	Dymax Corp	IYO	Class II	1986-12-11
K861305	Intrauterine Catheter	Ram Development	HDR	Class II	1986-12-11
K864149	Q-Scan II and Q-Scan III	Quinton, Inc.	DSI	Class II	1986-12-10
K864121	Pharmacokinetics Software System (Pps)	Pharmatrol, Inc.	NDC	Class II	1986-12-10
K864051	Tubulicid Red Label	Dental Dimensions Supply Co.	LBH	Class II	1986-12-10
K863907	Modified Sodium Electrode	Ionetics, Inc.	JGS	Class II	1986-12-10