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 3134 of 3528

510(k) clearances, page 3134 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832053	Single Patient Sys. II Model Dm-450	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1983-09-29
K832044	Shiley Multipro Catheter	Shiley, Inc.	DXE	Class II	1983-09-29
K832040	Sterile Fluid Producing Unit #Ep550	American Cystocope Makers, Inc.	LJH	Class II	1983-09-29
K832030	Heparin Coated Stainless Steel/teflon	Argon Medical Corp.	DOX	Class II	1983-09-29
K831999	Femoral Canal Suction Tampon	Richards Manufacturer Co.	JOL	Class II	1983-09-29
K831981	Laryngescope	W.E. Leder Enterprises, Inc.	CCW	Class I	1983-09-29
K831929	Basic Breast Pump	Terayco Intl., Ltd.	HGY	Class I	1983-09-29
K831878	Cardio-Scope Mini Monitor	W.E. Leder Enterprises, Inc.	DPS	Class II	1983-09-29
K831787	Patient Monitor #78353A	Hewlett-Packard Co.	DRT	Class II	1983-09-29
K831756	Anspach 65,000	The Anspach Effort, Inc.	HSZ	Class I	1983-09-29
K831752	Biocheck Pec-108 Program-Pulse Monitor	Biotechnology, Inc.	DRT	Class II	1983-09-29
K831525	H-Flu B Elisa Test	Seragen Diagnostics, Inc.	GRP	Class II	1983-09-29
K831512	Dosimetry Release of Radiation Steriliz	Zimmer GmbH	JDK	Class II	1983-09-29
K831439	Elastoplast T.p.n.	Beiersdorf, Inc.	FPX	Class I	1983-09-29
K830361	Mms Acetabular Cups	3M Company	JDI	Class II	1983-09-29
K822835	Pz-800 Volume Ventilator	Narco Scientific	CBK	Class II	1983-09-29
K832902	Middlebrook Adc Enrichment	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1983-09-26
K832881	Advantage Series Contoured Lumbo Sacar	Depuy, Inc.			1983-09-26
K832874	Isovis Wound Protector	Ritmed, Inc.	KKX	Class II	1983-09-26
K832870	Diazo Colorimetry, Billirubin	Horiba Instruments Incorporated	CIG	Class II	1983-09-26
K832868	Resuscitation Valve	Boehringer Laboratories, LLC	CBP	Class II	1983-09-26
K832863	Strep Id Quad	Troy Biologicals, Inc.	JSI	Class I	1983-09-26
K832862	Transgrow Medium	Troy Biologicals, Inc.	JTY	Class II	1983-09-26
K832861	Sabouraud Dextrose Agar	Troy Biologicals, Inc.	JSJ	Class I	1983-09-26
K832860	Sxt Blood Agar	Troy Biologicals, Inc.	JSJ	Class I	1983-09-26
K832840	Minimum Essential Med. Eagle M4642 W/	Sigma Chemical Co.	KIT	Class I	1983-09-26
K832839	Hanks Balanced Salt Mixture H6136	Sigma Chemical Co.	KIT	Class I	1983-09-26
K832838	Earles Balanced Salt Mixture #E6132	Sigma Chemical Co.	KIT	Class I	1983-09-26
K832837	Nutrient Mixture F-10 #N6635 W/l-Gluta	Sigma Chemical Co.	KIT	Class I	1983-09-26
K832820	Mul-T-Blanket	Gaymar Industries, Inc.	ILO	Class II	1983-09-26
K832819	Mul-T-Pad	Gaymar Industries, Inc.	ILO	Class II	1983-09-26
K832793	Neocath 1000 W/hepcote	Orange Medical Instruments, Inc.	CCE	Class II	1983-09-26
K832778	Epidural Syringe	Concord Laboratories, Inc.	CAZ	Class II	1983-09-26
K832770	Lane One	Loredan Biomedical, Inc.	IKK	Class II	1983-09-26
K832750	Easytouch Hemoglobin Reagent	Worthington Diagnostic Systems	KHG	Class II	1983-09-26
K832709	Skin Stapling Device Sc2000	Prosper, Inc.	GDT	Class I	1983-09-26
K832681	Universal Vol. Ventilator 72 #1626	Hudson Oxygen Therapy Sales Co.	BZO	Class I	1983-09-26
K832660	Oxygen Connecting Tubeset-Respiratory	San Diego Plastics, Inc.	BYX	Class I	1983-09-26
K832655	Ecolyzer #200/Cohb Analyzer Sys	BD Becton Dickinson Vacutainer Systems Preanalytic	CCJ	Class II	1983-09-26
K832654	Heated Gutta Percha Delivery System	Unitek Corp.	EKM	Class I	1983-09-26
K832643	Cell-Dyn 900 Hematology Analyzer	Abbott Diagnostics	GKL	Class II	1983-09-26
K832545	Arterial Blood Sampling Kit	Dhd Medical Products Div. Diemolding Corp.	CBT	Class I	1983-09-26
K832436	Selectro-Disc	Lab Ability, Inc.	JTO	Class I	1983-09-26
K832406	Quantum II Yeast Ident. System	Abbott Medical	JXC	Class I	1983-09-26
K832366	Zoller Burned Lip Conformer	Universal Prosthetics, Inc.	EIG	Class I	1983-09-26
K832359	Oral Safe	Great Lakes Orthodontics, Ltd.	JER	Class I	1983-09-26
K832286	Cerestore Core Material	Johnson & Johnson Professionals, Inc.	EIH	Class II	1983-09-26
K832246	Dupont Isolator 1.5 Microbial Tube	E.I. Dupont de Nemours & Co., Inc.	LIO	Class I	1983-09-26
K832220	Traveler Nebulizing System	Medix of Florida, Inc.	BTI	Class II	1983-09-26
K832118	Digident Elektronic Apex Locator	Ora-Muszeripari Szovetkezet			1983-09-26