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 2026-10-21, 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 3009 of 3529

510(k) clearances, page 3009 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850767	Spectronic 2000 Spectrophotometer	Bausch & Lomb Incorporated	JJQ	Class I	1985-03-14
K850587	Spq Test System for Alpha, - Antitrypsin	Applications Lab	DEM	Class II	1985-03-14
K850586	Spq Test System for Immunoglobulin M	Applications Lab	DAO	Class II	1985-03-14
K850527	Arthroscopy Suction Biopsy Punch	T. Korossurgical Instruments Corp.	HTZ	Class I	1985-03-14
K850423	Concept Suction Sleeve	Concept, Inc.	HTZ	Class I	1985-03-14
K850334	Roche Reagent for Chloride, for the Cobas	Roche Diagnostic Systems, Inc.	CHJ	Class II	1985-03-14
K842991	Autofluor V System	Tech America Diagnostics	DHN	Class II	1985-03-14
K841871	Liqua-Sonic Gel	Chester Labs, Inc.	GYB	Class II	1985-03-14
K850565	Biotis Chocolate Tellurite	Otisville Biotech, Inc.	JSI	Class I	1985-03-13
K850351	Phadebact Monoclonal Gc Test	Pharmacia, Inc.	LIC	Class II	1985-03-13
K850249	Bio-Tek Automated Microplate Washer El402	Bio-Tek Instruments, Inc.	JTC	Class I	1985-03-13
K850183	Cadd-Vt, 5300 Ambulatory Infusion Pump W/3050, 50M	Deltec Systems, Inc.	FRN	Class II	1985-03-13
K844847	Mobilchair 360 Electric-Powered Chair	Davis-Smith Corp.	ITI	Class II	1985-03-13
K844476	Portable Diagnostic Laboratory	Portable Medical Laboratories, Inc.	LIB	Class I	1985-03-13
K844434	Vaccess 3000 Single Lumen Jugular Cannula-Cath	Vas-Cath of Canada, Ltd.	LFJ	Class II	1985-03-13
K844433	Vaccess 2000 Single Lumen Subclavian Cannula	Vas-Cath of Canada, Ltd.	LFJ	Class II	1985-03-13
K844336	Vas-Cath Parallel Dual Luman Jugular Cannual Cath	Vas-Cath of Canada, Ltd.	LFJ	Class II	1985-03-13
K843487	Visitec Ophthalmic Fluid Distrib- Set	Visitec Co.	HQC	Class II	1985-03-13
K843311	IV Admin. Set for Mvp 1 Infusion Pump	Ziehm International, Inc.	FRN	Class II	1985-03-13
K842577	Cath-Tech Polyurethane Umbilical Vess	Catheter Technology Corp.	FOZ	Class II	1985-03-13
K841943	Gibco Herpes Id Kit	Gibco Laboratories Life Technologies, Inc.	GQL	Class II	1985-03-13
K850709	Spectronic 501 & 601 - Clinical Spectrophotometer	Bausch & Lomb Incorporated	JJQ	Class I	1985-03-12
K850647	Heated Respiratory Humififier Mr440	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1985-03-12
K850629	Innofluor Theophylline	Innotron Diagnostics	LGS	Class II	1985-03-12
K850626	Carnation Oxygen	Cathay Consolidated Inc.	BYG	Class I	1985-03-12
K850617	Corning 780 Fluorometer/densitometer	Corning Medical & Scientific	JQT	Class I	1985-03-12
K850569	Bsm 2000 Dialysis Machine - Modified	bioMerieux, Inc.	FKP	Class II	1985-03-12
K850563	Sechrist Ventilator/nautilus Chamber Combination	Nautilus Environmedical Systems, Inc.	CBF	Class II	1985-03-12
K850544	Shave Prep Tray	Packaging Technologies, Inc.	KME	Class I	1985-03-12
K850485	Rotor Systems a/s-400 & La/s-400	E.I. Dupont de Nemours & Co., Inc.	JQC	Class I	1985-03-12
K850355	Mentor Percutaneous Renal Dilator Set	Mentor	EZN	Class II	1985-03-12
K850348	Urotron Rl9	Boehringer Mannheim Corp.	JJQ	Class I	1985-03-12
K850339	Special Procedures Pack	Marwood Medical, Inc.	FPA	Class II	1985-03-12
K850335	Ureteroscopy Catheter	Inmed Corp.	KOD	Class II	1985-03-12
K850248	Disposable Guedel Airway	Inmed Corp.	CAE	Class I	1985-03-12
K850241	Alba Health Care Non-Adhering Dressing	Alba Health Care	FRO	Unclassified	1985-03-12
K850152	Preconnected Urethral Catheter Tray	Inmed Corp.			1985-03-12
K845031	Kareco Int'l - Dougle-Hook i.v. Stand	Kareco Intl., Inc.	FOX	Class I	1985-03-12
K844942	Plura-Gard Chest Drainage System	Consolidated Medical Equipment Company	KDQ	Class II	1985-03-12
K844817	Micro-Structured Hs3p Proportional Series Hip Stem	Osteonics Corp.	JDI	Class II	1985-03-12
K844630	Rope System Reverse Osmosis Peritoneal System	bioMerieux, Inc.	FKX	Class II	1985-03-12
K844488	Mecron Cemented Structured Stem Hip Prosthesis	Mecron Medical Products, Inc.	KWL	Class II	1985-03-12
K844416	Thermopuls E	Nemectron Medical, Inc.	IMJ	Class II	1985-03-12
K844401	Repro-Med Systems Infusion Device	Repro-Med Systems, Inc.	FRN	Class II	1985-03-12
K844008	Penlon Am1000 Anaesthesia Machine	Penlon, Ltd.	BSZ	Class II	1985-03-12
K844007	Penlon Ppv Vaporizer	Penlon, Ltd.	CAD	Class II	1985-03-12
K843953	Scanheads Access 10 10Pv B10	Advanced Technology Laboratories, Inc.	JOP	Class II	1985-03-12
K843924	Digital Electroneurometer S-100	Neurotron Inc	JXE	Class II	1985-03-12
K843620	Scanheads-Access 10Pv, Biostatic	Advanced Technology Laboratories, Inc.	JOP	Class II	1985-03-12
K843200	Site Strip	E-Med Corp.	NAD	Class I	1985-03-12