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 3112 of 3528

510(k) clearances, page 3112 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833600	Coulter Counter Model S-Plus V	Coulter Electronics, Inc.	GKZ	Class II	1984-01-10
K833568	Diatek 600 Thermometer System	Diatek, Inc.	FLL	Class II	1984-01-10
K833459	Coaxial Vol. Ventilator Circuit	Airco/Ohio Medical Products	BZO	Class I	1984-01-10
K833455	Remoldable Craniomandibular Appliance	Jeffrey H. Attlin	KMY	Class I	1984-01-10
K833420	Kinetix Mouthpiece	Kinetix	BYP	Class I	1984-01-10
K833403	Bdh Unipolar Femoral Component A2	Carbomedics, Inc.	KWL	Class II	1984-01-10
K833399	Syringe	I M, Inc.	FMF	Class II	1984-01-10
K833395	Sentinel Systems	Quantitative Medicine, Inc.	DXG	Class II	1984-01-10
K833162	Ambulatory Monitoring Device	Oxford Medilog, Inc.	DSI	Class II	1984-01-10
K833077	Wellcogen H. Influenzal Zl21	Wellcome Diagnostics	GRD	Class I	1984-01-10
K833063	Wellcogen N. Meningitidis A,c,y W135	Wellcome Diagnostics	GTJ	Class II	1984-01-10
K832912	Gelender Vacuum Fixation Ring Sys	Miami Eye Technology, Inc.	HNH	Class I	1984-01-10
K832907	Invasive Monitoring Kits	American Pharmaseal Div. Ahsc	DRS	Class II	1984-01-10
K832817	Telemetry Sys Series 7700 ECG	Marquette Electronics, Inc.	DRG	Class II	1984-01-10
K832115	Atac 3000	Turpen Laboratory Systems, Inc.	JJE	Class I	1984-01-10
K834143	Nylon Compression Stump Sheath	Ipos Luneburg			1984-01-09
K833923	Marz-175 Arterial Blood Gas Syringe	Chesebrough-Pond'S U.S.A. Co.	CBT	Class I	1984-01-09
K833504	Pregnastick Urine Hcg Kit	Monoclonal Antibodies, Inc.	JHJ	Class II	1984-01-09
K831728	Medicalex	Medicalex	FQM	Class I	1984-01-09
K833405	Irrigation Aspiration Kit	American Medical Optics	HQC	Class II	1984-01-06
K831516	Gore-Tex Surgical Membrane	W. L. Gore & Associates, Inc.	DXZ	Class II	1984-01-06
K834286	Bi-Plane Digital Fluorography Dfx7000	Philips North America LLC	JAA	Class II	1984-01-04
K834265	Trach Mate	Tempe Biomedical, Inc.	JAY	Class I	1984-01-04
K834066	Tinsdale Enrichment	Remel Co.	JSK	Class I	1984-01-04
K833984	Antinuclear Antibody Immunological	Intl. Diagnostic Technology	KTL	Class II	1984-01-04
K833969	Mast Total Ige	Mast Immunosystems	DGC	Class II	1984-01-04
K833956	Dot Visual Acvity Test 2000	Good-Lite Co.	HOX	Class I	1984-01-04
K833885	Mast Inhalant Profile	Mast Immunosystems	DHB	Class II	1984-01-04
K833841	Il Test Igg Iga & Igm Kits	Instrumentation Laboratory Co.	CZK	Class II	1984-01-04
K833820	Machemer/tano Rotating	Optical Micro Systems, Inc.	HRJ	Class I	1984-01-04
K833800	Beecher 20 Ga. Probe	Beecher Medical Diagnostic Instrumentation	HQC	Class II	1984-01-04
K833778	Testing Visual Acuity	Technical Enginuities Co.	HOX	Class I	1984-01-04
K833745	Riacoat T-4	Immuno Assay Corp.	CDX	Class II	1984-01-04
K833708	Compur* M1000 Hemoglobin & Erythrocyte	Worthington Diagnostic Systems	LKZ	Class II	1984-01-04
K833702	Aca Thyroxine Uptake Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1984-01-04
K833639	Titangel High Resolution Control	Helena Laboratories, Corp.	JJY	Class I	1984-01-04
K833494	Clerz Lubricating/rewetting Solution	CooperVision, Inc.	HKX	Class II	1984-01-04
K833371	Disposable Ocutome Probe	CooperVision, Inc.	HQE	Class II	1984-01-04
K833064	Storz Extra	Storz Instrument Co.	HQC	Class II	1984-01-04
K832843	Oscar Colour Vision Tester	Keeler Instruments, Inc.	HIT	Class I	1984-01-04
K832560	Aspirating Handle W/backflushing Capab	Precision Medical Instruments, Inc.			1984-01-04
K832529	M.s.d. Aspirator	Medical Surgical Designs	HQC	Class II	1984-01-04
K834215	Mini-1 Transcutaneous Elec-Nerve Stim	Th Charters, Inc.	GZJ	Class II	1984-01-03
K834206	Eugonic Agar	Neogen Culture Media	JSG	Class I	1984-01-03
K834205	Middlebrook & Cohn 7H10 Agar Base	Neogen Culture Media	JSH	Class I	1984-01-03
K834204	Middlebrook & Cohn 7H11 Agar Base	Neogen Culture Media	JSH	Class I	1984-01-03
K834068	Ceb	Remel Co.	JSJ	Class I	1984-01-03
K834067	Legionella Differentiation Disk	Remel Co.	GRO	Class II	1984-01-03
K834043	Msi-Hc Hematology Control	Medical Specialties Inc.	JPK	Class II	1984-01-03
K834039	Infant Vent Catheter 12001 W/side Vent	Dlp, Inc.	DWF	Class II	1984-01-03