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 3157 of 3528

510(k) clearances, page 3157 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830990	Blakemore Tube	Medovations, Inc.	KNT	Class II	1983-06-02
K830989	Baker Jejunostomy Tube	Medovations, Inc.	KNT	Class II	1983-06-02
K830926	160/260 Suction Coagulator	Zimmer GmbH	GEI	Class II	1983-06-02
K830881	Ampercide Disinfectant Accessory to -	American Medical Products LLC	FKX	Class II	1983-06-02
K830871	Phakosystems Model 1000/Omni Packs Irrigation/aspiration	Phakosystems, Inc.	HOC	Class I	1983-06-02
K830740	Clerz Lubricating & Rewetting Eye Drops	CooperVision, Inc.	HPX	Unclassified	1983-06-02
K830737	Jermyn Occluders Kit	Jermyn Specialties of California			1983-06-02
K830628	Real-Time Spectrum Analyzer	Diagnostic Electronics Corp.	DXG	Class II	1983-06-02
K830584	Soileau Tytan Bobbin Vent Tube	Treace Medical, Inc.	ETD	Class II	1983-06-02
K830298	Accu-Line Surgical Marker	Accu-Line	FZZ	Class I	1983-06-02
K830271	Lapet & Lapwall Laparotomy Sponges	Ritmed, Inc.	EFQ	Unclassified	1983-06-02
K830269	Floret Neuro Sponge	Ritmed, Inc.	EFQ	Unclassified	1983-06-02
K830084	Angioscope	Trimedyne, Inc.	LYK	Class II	1983-06-02
K830050	Molnlycke Mepore Sterile Self-Adhesive	Lada Intl., Inc.	NAD	Class I	1983-06-02
K830005	Ip Specific G	Diagnostic Reagent Tech.	DAA	Class II	1983-06-02
K822824	Adhesive Tape/first-Band	Leonard Joseph Co.	KGX	Class I	1983-06-02
K837343	Pz-600 Computerized Axial Tomography Scanner	Phoenix Medical Electronics			1983-05-31
K830747	Pc 2909A-Health Pulse Control Stimulator	J.A. Preston Corp.	GZJ	Class II	1983-05-30
K831369	Latex Urinary Catheters	Wayne Surgical Products	KOD	Class II	1983-05-27
K831364	Testcorp Ra	Myo-Tronics Research, Inc.	DCN	Class II	1983-05-27
K831362	Testcorp Crp	Catheter Technology Corp.	DCN	Class II	1983-05-27
K831354	Emit Qst Lidocaine Assay	Syva Co.	KLR	Class II	1983-05-27
K831348	Fluid Admin. Set Afs-1C	Linton Biomed Corp.	DRS	Class II	1983-05-27
K831338	Lundia 10-3-L Parallel Flow Dialyzer	Gambro, Inc.	KOC	Class II	1983-05-27
K831324	EEG 42/2P Electro Encephalograph	Nihon Kohden America Inc	GWQ	Class II	1983-05-27
K831278	Liqui-Sera Anticonvulsants Controls	Biodiagnostic Intl	DIF	Class I	1983-05-27
K831272	Emit Qst Theophylline Assay	Syva Co.	KLS	Class II	1983-05-27
K831225	Gas-Stat Monitoring System	Cardiovascular Devices, Inc.	DRY	Class II	1983-05-27
K831185	Cardiac Output Measure System	Cook, Inc.	DYG	Class II	1983-05-27
K831180	Pregna-Cert, Slide Pregnancy Test	Diagnostic Specialties	JHJ	Class II	1983-05-27
K831178	Coat-a-Count No-Extraction Aldosterone	Siemens Healthcare Diagnostics Inc.	CJM	Class II	1983-05-27
K831141	Emit Srd Manual Cortisol Assay	Syva Co.	CGR	Class II	1983-05-27
K831039	Complus Various Forms	Parker Laboratories, Inc.			1983-05-27
K830994	Redox Controller	St. Louis Univ. Medical Center	KDN	Class II	1983-05-27
K830987	Levin Tube	Medovations, Inc.	KNT	Class II	1983-05-27
K830986	Rectal Tubes	Medovations, Inc.	KNT	Class II	1983-05-27
K830985	Stomach Tube	Medovations, Inc.	KNT	Class II	1983-05-27
K830844	Portable Oxygen System	Medtronic, Inc.	CAN	Class I	1983-05-27
K830646	Directigen Neisseria Meningitidis	BD Becton Dickinson Vacutainer Systems Preanalytic			1983-05-27
K830585	Anvil Retractor	Twin City Surgical, Inc.	GAD	Class I	1983-05-27
K830354	Colorectal Dilator	Cleveland Medical Supply & Services	FFP	Class I	1983-05-27
K830344	Siemens-Elma Pulse Generator #718	Burditt & Calkins-Siemens-Elema	DXY	Class III	1983-05-27
K830190	Ahr-3000 Re-Use Adaptor	Colorado Medical, Inc.	LIF	Class II	1983-05-27
K823487	Bard Ureteral Stent	C.R. Bard Inc	FAD	Class II	1983-05-27
K831367	Pmn Volz Curettes	3M Company	FZS	Class I	1983-05-25
K831334	Tissue Cassettes for Processing-Em Bed	Surgipath Medical Industries, Inc.	IDZ	Class I	1983-05-25
K831333	Embedding Rings	Surgipath Medical Industries, Inc.	KER	Class I	1983-05-25
K831312	Lopez-Horn Carrier	Chiron Vision Corp.	KYP	Class I	1983-05-25
K831303	Telectronics #030-253 Bifurcated	William C. Nealon	DTB	Class III	1983-05-25
K831262	Data IV Ambulatory Monitor	Cardio-Scan of Texas	DSH	Class II	1983-05-25