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 2026-10-12, 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 3265 of 3528

510(k) clearances, page 3265 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812694	Whisk-R	Medi-Spec	GEE	Class I	1981-10-26
K812644	Replaceable Battery Perfectemp 2 Caut	Key Medical, Inc.	GEI	Class II	1981-10-26
K812637	Acmi Bipolar Hemostatic Source	American Cystocope Makers, Inc.	GEI	Class II	1981-10-26
K812624	Oxequip Conductive & Non Anes. Breath	Oxequip Health Ind.	CAI	Class I	1981-10-26
K812205	Forcep	Reznik Instruments	GEN	Class I	1981-10-26
K812861	Cholesterol Calibrators	Gilford Diagnostics	JIS	Class II	1981-10-23
K812848	Accra Lab Hemotology	Accra Laboratories, Inc.	IAF	Class I	1981-10-23
K812844	Moxalactam 30Mcg. Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1981-10-23
K812826	Forma Ch/p Gas Processor	Forma Scientific, Inc.	JTQ	Class I	1981-10-23
K812818	Titertek Autodrop	Flow Laboratories, Inc.	JTC	Class I	1981-10-23
K812786	Ferritin(125i) Radioimmunoassay Test Sys	Corning Medical & Scientific	DBF	Class II	1981-10-23
K812783	Trimethoprim 5Mcg. Antimicrobial Disk	General Diagnostics	JTN	Class II	1981-10-23
K812782	Dispenser Aspirator Da 300	Pharmacia, Inc.	JQW	Class I	1981-10-23
K812774	Ventilator Circuit	Hudson Oxygen Therapy Sales Co.	BZO	Class I	1981-10-23
K812773	Bennett Volume Ventilator Circuit	Ideal Medical, Inc.	BZO	Class I	1981-10-23
K812748	Monoject M535 35Cc Syringe	Sherwood Medical Co.	FMF	Class II	1981-10-23
K812747	Argyle Suction Catheters	Sherwood Medical Co.	BSY	Class I	1981-10-23
K812741	Reagents for Serodiagnosis of Candidosis	Nolan Biological Laboratories, Inc.	LHK	Class II	1981-10-23
K812737	Rain-X	Nova-Ventrx	BZO	Class I	1981-10-23
K812730	Septi-Chek Columbia Broth Blood Culture	Hoffmann-La Roche, Inc.	JSG	Class I	1981-10-23
K812709	Sterile Dental Roll	Medspec Corp.	EFN	Class I	1981-10-23
K812703	Model 9408 a Teletrace	Medtronic, Inc.	DXH	Class II	1981-10-23
K812692	Files & Reamers	Miltex Instrument Co.	EKS	Class I	1981-10-23
K812667	Meddars/ultra Imager Respiration Module	Honeywell, Inc.	BZQ	Class II	1981-10-23
K812657	Injection Cap, Luer Lock	Procedure Products, Inc.	FPA	Class II	1981-10-23
K812599	Medtronic #4951	Medtronic, Inc.	DTB	Class III	1981-10-23
K812573	Spirometer Filter	K & G Healthcare Ind., Inc.	CAH	Class II	1981-10-23
K812565	Elution Solution	Biological Corp. of America	KSG	Class II	1981-10-23
K812564	Zee Life Support Air Pants	Zee Medical Products Co., Inc.	LHX	Class II	1981-10-23
K812531	Cell Culture Reagents	M.A. Bioproducts	KIT	Class I	1981-10-23
K812455	Sucker Cardiotomy Return, C.p. Bypass	Electromedics, Inc.	DTN	Class II	1981-10-23
K812428	Helena Coloscreen Method	Helena Laboratories, Corp.	KHE	Class II	1981-10-23
K812292	Autotrans Bt795	Electromedics, Inc.	CAC	Class II	1981-10-23
K812282	Portable Oxygen Generator	American Marketing Assoc., Inc.	CAW	Class II	1981-10-23
K811713	Avi-D Control	Ortho Diagnostic Systems, Inc.	KSF	Class II	1981-10-23
K810592	Nuclear Antigens	Alpha Antigens, Inc.	LLL	Class II	1981-10-23
K812801	Hip Stem System Titanium Alloy	Osteonics Corp.	JDI	Class II	1981-10-20
K812800	Flow-Directed Thermodilution Catheter	Sorensen Research	KRB	Class II	1981-10-20
K812799	Dcats	Dorex, Inc.	IYM	Class III	1981-10-20
K812798	Motility Gi Medium	Isle Media and Sterile Products, Inc.	JSG	Class I	1981-10-20
K812797	Schaedler Agars	Isle Media and Sterile Products, Inc.	JSG	Class I	1981-10-20
K812796	Anaerobic Cna Blood Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1981-10-20
K812795	Anaerobic Blood Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1981-10-20
K812794	Lipase	Horiba Instruments Incorporated	CET	Class I	1981-10-20
K812784	Beckman Astra Sys. Total Bilirubin Mod	Beckman Instruments, Inc.	CIG	Class II	1981-10-20
K812763	ECG Medatape-601	Hospital Equipment Service	DSH	Class II	1981-10-20
K812762	Il 501, Na/k Analyzer	Instrumentation Laboratory Co.	JGS	Class II	1981-10-20
K812758	Physiological Pressure Transducer	Electromedics, Inc.	DRS	Class II	1981-10-20
K812740	Reagents for Serodiagnosis of Aspergill	Nolan Biological Laboratories, Inc.	JWT	Class I	1981-10-20
K812651	X-Ray Detectable Lap Sponges	Procter & Gamble Mfg. Co.	GDY	Class I	1981-10-20