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 3004 of 3529

510(k) clearances, page 3004 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850570	Stratus Hcg Fluorometric Enzyme Immunoassay	American Dade	JHI	Class II	1985-04-02
K850531	Leeco Concep-7-Bhcg Eia	Leeco Diagnostics, Inc.	JHI	Class II	1985-04-02
K850530	Leeco Concep-7-Bhcg Irma	Leeco Diagnostics, Inc.	JHI	Class II	1985-04-02
K850071	Teca Mf-20 Microvascular Doppler	Teca, Inc.	IYN	Class II	1985-04-02
K850004	Transcutaneous Nerve Stimulator for Pain Relief	Todd Medical, Inc.	GZJ	Class II	1985-04-02
K844850	Medicorp Dehydracon a Dehydrated Dialysate Concent	Medicorp, Inc.	FKQ	Class II	1985-04-02
K843922	Osteon Bone Mineral Analyzer	Osteon, Inc.	KGI	Class II	1985-04-02
K832170	Muffler Gas-Air Vent Unit	Dr. Edward Richards	KNT	Class II	1985-04-02
K851184	Spottest India Ink	Difco Laboratories, Inc.	JTO	Class I	1985-04-01
K851062	Derapage Eyewear by Vitaloni	Vitaloni S.p.A.	HQY	Class I	1985-04-01
K851039	Eyedentity Eyewear	Vitech Research C/O Johnsen, Manfredi & Thorpe	HQZ	Class I	1985-04-01
K850998	Uri-Kit	Culture Kits, Inc.	JSG	Class I	1985-04-01
K850986	Date Chem Inorganic Phosphorous u.v. Procedure	Data Medical Associates, Inc.	CEO	Class I	1985-04-01
K850953	Emit 700 Methadone Assay	Syva Co.	DJR	Class II	1985-04-01
K850901	Data Chem Auto-Bilirubin/direct Procedure	Data Medical Associates, Inc.	CIG	Class II	1985-04-01
K850659	Syva 700 System Accessories-Clinical Chem Analyzer	Syva Co.	JQP	Class I	1985-04-01
K850651	Programalith III-3 Model 231 Pulse Generator	Pacesetter Systems	DXY	Class III	1985-04-01
K850606	Ceftriaxone 30 Mcg Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1985-04-01
K850555	Chocolate Agar W/bacitracin, Chocolate W/bacitraci	Hardy Media	JSJ	Class I	1985-04-01
K850506	Correct Flo Intravascular Administration Set	Biomedical Dynamics, Inc.	FPA	Class II	1985-04-01
K850503	Secu-Tape Universal Flexible Medical Clamps	Turn Needle Intl., Inc.	KMK	Class I	1985-04-01
K850470	Bed Products	Abco Dealers, Inc.	FMQ	Class I	1985-04-01
K850405	Calibrator B 88133	Hi Chem, Inc.	JIX	Class II	1985-04-01
K850250	Technicon Testpoint Assayed Hematology Low & High	Technicon Instruments Corp.	JPK	Class II	1985-04-01
K850239	Sysmex Hematological Whole Blood Diluting Reagent-	Toa Medical Electronics USA, Inc.	GIF	Class I	1985-04-01
K844995	Synchro-Link -Contin-Passive Motion Device/muscle	Cropper Medical, Inc.	BXB	Class I	1985-04-01
K844989	Flo-Phoresis - Desensitizer	Eastco, Inc.	EGS	Class I	1985-04-01
K844976	Medi-Man Water Powered Bath Lift & Hydraulic Lift	Medi-Man Rehabilitation Products, Inc.	FSA	Class I	1985-04-01
K844920	Csr Wrap - Central Supply Room Wrap for Steril-	Papeteries Depont-Audemer	FRG	Class II	1985-04-01
K844910	Sysmex Cc-800/Pda-410 W/tri-Modal Leukocyte Size -	Toa Medical Electronics USA, Inc.	GKZ	Class II	1985-04-01
K844839	Dinamap Vital Signs Monitor 1846 Sx & 1846P Sx	Critikon Company, LLC	DXN	Class II	1985-04-01
K844726	Gauze Sponge 4X4x12 Ply	Applied Medical	EFQ	Unclassified	1985-04-01
K844702	Gauze Asorbable	Medicon Co., Ltd.	EFQ	Unclassified	1985-04-01
K844677	Applied Gauze Sponge 2X2x12	Applied Medical	EFQ	Unclassified	1985-04-01
K844676	Applied Gauze Sponge 4X4x8	Applied Medical	EFQ	Unclassified	1985-04-01
K844675	Applied Gauze Sponge 3X3x12	Applied Medical	EFQ	Unclassified	1985-04-01
K844674	Applied Gauze Sponge 2X2x8 Ply	Applied Medical	EFQ	Unclassified	1985-04-01
K844673	Applied Gauze Sponge 4X4x16 Ply	Applied Medical	EFQ	Unclassified	1985-04-01
K844353	Physiological Monitor 2100	Datascope Corp.	DXN	Class II	1985-04-01
K851020	Mic-Concept Inoculator	Microtech Medical Systems, Inc.	JTC	Class I	1985-03-29
K851019	Mic-Concept Inoculum Seed Tray	Microtech Medical Systems, Inc.	JTC	Class I	1985-03-29
K850991	Landers Vitrectomy Lens Ring Systems	Ocular Instruments, Inc.	HNH	Class I	1985-03-29
K850982	Ctapi - Neissera Screen	Analytical Products, Inc.	JSE	Class I	1985-03-29
K850970	Brain Heart Infusion Agar W/5% Sheep Blood, Chlora	Granite Diagnostics, Inc.	JSJ	Class I	1985-03-29
K850969	Inhibitory Mold Agar Plate	Granite Diagnostics, Inc.	JSJ	Class I	1985-03-29
K850944	Nsi Lysing-D Reagent -4000 Ml	Nobel Scientific Industries, Inc.	GGK	Class I	1985-03-29
K850900	Phaco-Bac Stop Kit	Staar Surgical AG	HQC	Class II	1985-03-29
K850899	I/a Bac Stop Kit	Staar Surgical AG	HQC	Class II	1985-03-29
K850857	I/a Handpiece	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1985-03-29
K850856	Ics Theophylline Reagents	Beckman Instruments, Inc.	KLS	Class II	1985-03-29