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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3063 of 3528

510(k) clearances, page 3063 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841832	Glottal Frequency Analyser	Teltec Electronic Equipment AB	KLX	Class II	1984-07-18
K841740	Terumo Digital Clinical Thermometer	Terumo Medical Corp.	FLL	Class II	1984-07-18
K841568	Impedance/pure Tone Audiometer Ma620	Maico Hearing Instruments, Inc.	ETY	Class II	1984-07-18
K841399	Bronchoscope Suction Unit	Keymed, Inc.	BTA	Class II	1984-07-18
K841359	Fenestra Hook	Treace Medical, Inc.	IYL	Class II	1984-07-18
K841356	Elevator	Treace Medical, Inc.	KAD	Class I	1984-07-18
K841322	Optimist Sized Particle Aerosol Nebuliz	Airmed Corp.	FLL	Class II	1984-07-18
K841318	A.s.a.p.	Trimedyne, Inc.	LDR	Class II	1984-07-18
K840882	Home Care Water Flotation Bed Hc4/tc/h	Western Medical, Ltd.	IOQ	Class II	1984-07-18
K840881	Water Floation Bed 800/Tc/h	Western Medical, Ltd.	IOQ	Class II	1984-07-18
K831356	Steam Sterilizer	Ars Enterprises, Inc.	FLE	Class II	1984-07-18
K842354	EMG Model 133	Calnor of el Paseo, Inc.	HCC	Class II	1984-07-17
K842353	Temperature 132	Calnor of el Paseo, Inc.	HCC	Class II	1984-07-17
K842340	Vh820 Humidifier	Bear Medical Systems, Inc.	BTT	Class II	1984-07-17
K842288	EEG 130	Calnor of el Paseo, Inc.	HCC	Class II	1984-07-17
K842265	Ortho Brand Home Pregnancy Test	Advanced Care Products	LCX	Class II	1984-07-17
K842184	Spot-Film Device 8835	General Electric Co.	IXL	Class II	1984-07-17
K842108	Universal Examination Table	Engineering Dynamics Corp.	GZO	Class II	1984-07-17
K842102	Lorad	Lorad Medical Systems, Inc.	IZH	Class II	1984-07-17
K841895	Gsr, 126, EEG 130-Temp. 132, EMG 133	Calnor of el Paseo, Inc.	HCC	Class II	1984-07-17
K841566	Hesung Disposable Syringe	Amkor Trading Co.	FMF	Class II	1984-07-17
K841565	Hesung's Hyperdermic Needles	Amkor Trading Co.	FMI	Class II	1984-07-17
K841564	Hesung Scalp Vein Set	Amkor Trading Co.	FPA	Class II	1984-07-17
K841563	Hesung's Solution Infusion Sets	Amkor Trading Co.	FPA	Class II	1984-07-17
K841559	Conforma	Beiersdorf, Inc.	GBI	Class I	1984-07-17
K841463	Bone Densitometer	Norland Corp.	KGI	Class II	1984-07-17
K840613	Colon Irrigation Unit	Colenz Co.	KPL	Class II	1984-07-17
K840098	Model 811 Veri/tens & Po	Verite	GZJ	Class II	1984-07-17
K831148	High Filtration ISO-Mask	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1984-07-17
K842276	Sunmaster	Mt. Hood Mfr., Inc.	IOB	Class II	1984-07-16
K842168	Atago Urine Specific Gravity & Serum	Kyoto Diagnostics, Inc.	JRE	Class I	1984-07-16
K842006	Citoject Cartridge Syringe	Miles Laboratories, Inc.	EJI	Class II	1984-07-16
K841996	Maxicamera 400T W/body Contour Tomogra	General Electric Co.	JAM	Class I	1984-07-16
K841787	Radcal Model 4050 Radionuclide Calib	Radcal	KPT	Class II	1984-07-16
K841786	Radcal Model 4051 Radionuclide Calibra	Radcal	KPT	Class II	1984-07-16
K841785	Radcal Model 4046 Radionuclide Calibr	Radcal	KPT	Class II	1984-07-16
K841731	Brimfield Fiberoptic Light Scource	Brimfield Scientific Instruments	EQH	Class I	1984-07-16
K841558	Banana Cuff	Aspen Laboratories, Inc.	KCY	Class I	1984-07-16
K841153	Adaptor Hr-3000 Reuse	Colorado Medical, Inc.	LIF	Class II	1984-07-16
K841128	Relax Stress Reduction Sys	Synapse Software Corp.	HCC	Class II	1984-07-16
K840542	Mini-Doppler Es-100	Hayashi Denki Co., Ltd.	JOP	Class II	1984-07-16
K842535	Pentad Vocalizer	Pentad Corp.	ILQ	Class II	1984-07-13
K842436	Erika Negative Press. Arterial Blood	Erika, Inc.	KOC	Class II	1984-07-13
K842336	Disposable Pillow	Monterey Mills, Inc.	KME	Class I	1984-07-13
K842195	Advanced Cardiovascular-Coronary Guid	Advanced Cardiovascular Systems, Inc.	DQO	Class II	1984-07-13
K842176	Raaf Dual Lumen Catheter	Quinton, Inc.	DQY	Class II	1984-07-13
K842113	Amendment to Angiography Kit W/addit	Mallinckrodt Critical Care	DRE	Class II	1984-07-13
K842004	Percutaneous Catheter Introducer Set	Aries Medical, Inc.	DYB	Class II	1984-07-13
K841922	Accupro Volumetric Infusion Pump W/rs232	American Edwards Laboratories	FRN	Class II	1984-07-13
K841910	Kerr Sealapex Root Canal Sealer	Sybron Corp.	EJK	Class II	1984-07-13