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 3184 of 3528

510(k) clearances, page 3184 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823577	Cobas Reagent for Calcium	Hoffmann-La Roche, Inc.	CIC	Class II	1983-01-07
K823576	Cobas Standard for Total Protein	Hoffmann-La Roche, Inc.	LER	Class II	1983-01-07
K823575	Cobas Standards for Albumin	Hoffmann-La Roche, Inc.	CIX	Class II	1983-01-07
K823574	Cobas Reagent for Albumin	Hoffmann-La Roche, Inc.	CIX	Class II	1983-01-07
K823573	Cobas Reagent for Creatinine	Hoffmann-La Roche, Inc.	CGX	Class II	1983-01-07
K823572	Cobas Standards for Creatinine	Hoffmann-La Roche, Inc.	CGX	Class II	1983-01-07
K823561	Urethral Pressure Profile & Temp. Modul	Nihon Kohden America Inc	FAP	Class II	1983-01-07
K823550	Ck-Isozyme u.v. Reagent Set	Gelman Sciences, Inc.	JHT	Class II	1983-01-07
K823513	Central Supply Room Wrap	James River Corp.	FRG	Class II	1983-01-07
K823497	Wright Care	Dow Corning Wright	GZJ	Class II	1983-01-07
K823491	Birt-a-Switch Dsp #712	Birtcher Corp.	GEI	Class II	1983-01-07
K823430	Instra-Safe	Instranetics, Inc.	FSM	Class I	1983-01-07
K823338	Cobe Hemoconcentrator 1.3	Cobe Laboratories, Inc.	KDI	Class II	1983-01-07
K823261	Interface Transfusion Blood Filter #30	Medical, Inc.	CAK	Class II	1983-01-07
K823186	Estrocept Stabilized Estrogen Receptor	Brl	JJX	Class I	1983-01-07
K823178	Tel-Star Nu-Way & Generic E	Omni Hearing Systems	ESD	Class I	1983-01-07
K823118	Say	Kells Medical, Inc.	ESE	Class I	1983-01-07
K823078	Spunguard Face Mask	Kimberly-Clark Corporation	FXX	Class II	1983-01-07
K823073	101M in-the-Ear	Danavox, Inc.	ESD	Class I	1983-01-07
K822641	Gore-Tex Barrier Surg. Drapes & Gowns	W. L. Gore & Associates, Inc.	KKX	Class II	1983-01-07
K820126	Rapid Bacteriuria Screening Test	Analytical Luminescence Laboratory, Inc.	JXA	Class I	1983-01-07
K828056	Model 716 Micromanipulator	Laser Industries, Ltd.			1983-01-06
K823747	24 Cell Wells Tissue Culture	Corning Medical & Scientific	KJG	Class I	1983-01-05
K823740	Advance System Emitaed Antiepileptic	Syva Co.	DKB	Class II	1983-01-05
K823731	Cardf	Shiley, Inc.	DTP	Class II	1983-01-05
K823719	Aml (Angle Magnifying Lens	Nikon, Inc.	HKI	Class II	1983-01-05
K823707	Hospal Blood Lines	Hospal Medical Corp.	KOC	Class II	1983-01-05
K823697	Prep Type a Extraction Cartridge	E.I. Dupont de Nemours & Co., Inc.	DJY	Class I	1983-01-05
K823688	Double Antibody Tsh I-125 Radioimmuno	Corning Medical & Scientific	JLW	Class II	1983-01-05
K823680	Coat-a-Count Morphine Kit & Components	Siemens Healthcare Diagnostics Inc.	DDE	Class I	1983-01-05
K823675	Froning Guidance System #Tx-8200	Today'S Machining & Design, Inc.	HAW	Class II	1983-01-05
K823587	Uni-Cell	Medical Specialties Laboratories	GLQ	Class II	1983-01-05
K823582	Oxygen Concentrator Ucc-100	Linde Div. Union Carbide Corp.	CAW	Class II	1983-01-05
K823555	Magtarak Respiratory Monitor & Flow Sens	Penlon, Ltd.	BZK	Class II	1983-01-05
K823554	Acoh Wellness Tester	Occupational Health, Inc.	EWO	Class II	1983-01-05
K823553	Corcath H & B Vascular Access Catheter	Cormed, Inc., Sub. C.R.Bard, Inc.	LJS	Class II	1983-01-05
K823532	Stock #64091-Pediatric Oxygen Mask	B & F Medical Products, Inc.	BYG	Class I	1983-01-05
K823490	Ortho Bi-Level Assayed Lipid Profile	Ortho Diagnostic Systems, Inc.	JJY	Class I	1983-01-05
K823449	Respiratory Gas Analyzer	Thoratec Laboratories Corp.	CCL	Class II	1983-01-05
K823381	Professional Mark I Biofeedback Sys	Srs Co.	HCC	Class II	1983-01-05
K823359	Oxygen Consumption Monitor #Ocm-0100	Bentley Laboratories, Inc.	DRY	Class II	1983-01-05
K823273	Bos-2S, Spiraflo Bubble Infant Oxygen.	Bentley Laboratories, Inc.	DTZ	Class II	1983-01-05
K822908	Coherent Fundusl Retinal Camera	Coherent Medical Division	HKI	Class II	1983-01-05
K821897	Lens	Mortan, Inc.	KYG	Class I	1983-01-05
K828654	Uvb Cabinet or Goekerman Cabinet, Model Spectra 305	Daavlin Co.			1983-01-03
K828619	Ohmicron Mammography X-Ray System Model Omc 4520M	Ohmic, Ltd.			1983-01-03
K828606	Model Pdx-4800 Projection Digital X-Ray System	Philips North America LLC			1983-01-03
K828605	Beam Limiting Device	Rinn Corp.			1983-01-03
K828585	Opthalas Photocoagulator	Synemed, Inc.			1983-01-03
K828575	F-100 Fluoroscopic Control and Xf-100 High Voltage Generator	Interchange Manufacturer Corp.			1983-01-03