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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1979 of 3531

510(k) clearances, page 1979 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962169	Magneto Eyewear	Nike, Inc.	HQY	Class I	1996-06-24
K962021	Ciba Corning 348 System	Ciba Corning Diagnostics Corp.	CHL	Class II	1996-06-24
K961965	Sure Check Pregnancy Test	Chembio Diagnostic Systems, Inc.	LCX	Class II	1996-06-24
K961570	Kec-3840L/f, Video Colonoscope (*L or F in Model Number Denotes Length)	Pentax Precision Instrument Corp.	FDF	Class II	1996-06-24
K961569	Dall-Miles Stainless Steel Beaded Cable	Howmedica Corp.	JDQ	Class II	1996-06-24
K961567	Es-3840, Video Sigmoidoscope	Pentax Precision Instrument Corp.	FAM	Class II	1996-06-24
K961317	Syphilis Igm Human Serum Controls	Pyramid Biological Corp.	LIP	Class II	1996-06-24
K955102	Biodata Testosterone Maia Kit	Biochem Immunosystems (U.S.), Inc.	CDZ	Class I	1996-06-24
K954281	Panasil Impression Material	Roydent Dental Products, Inc.	ELW	Class II	1996-06-24
K943657	Sterilization	Telectronics Pacing Systems, Inc.	DTB	Class III	1996-06-24
K933705	Laminoss Dental Implant	Impladent, Ltd.	DZE	Class II	1996-06-24
K962126	Acs Ckmb II Immunoassay	Ciba Corning Diagnostics Corp.	JHS	Class II	1996-06-21
K962073	Urethral Catheterization Tray/universal Urethral Cath Tray	Continental Medical Laboratories, Inc.	FCM	Class II	1996-06-21
K962041	Acs Lh2 Immunoassay	Ciba Corning Diagnostics Corp.	CEP	Class I	1996-06-21
K961853	Proline Fast Pass Arthoscopic Needle Passer	Acufex Microsurgical, Inc.	HRX	Class II	1996-06-21
K961749	Transamerica Electrode	Transamerica Medical Systems	GZJ	Class II	1996-06-21
K961694	Impact	Matrix Technologies Corp.	JQW	Class I	1996-06-21
K961436	Abuscreen Online Lsd Reagent (90 Ml Test Kit)	Roche Diagnostic Systems, Inc.	DLB	Class II	1996-06-21
K961337	Exactech Rsg Blood Glucose Testing System	Medisense, Inc.	CGA	Class II	1996-06-21
K961326	Easy Stat Sodium/potassium/lithium Analyzer	Medica Corp.	CEM	Class II	1996-06-21
K961282	Glucose-Sl Assay, Catalogue No. 235-60	Sekisui Diagnostics P.E.I. Inc.	CFR	Class II	1996-06-21
K961225	Continuflo Solution Set/secondary Medication Set	Baxter Healthcare Corporation	FPA	Class II	1996-06-21
K961219	Percutaneous Introducer System	Boston Scientific Corporation	GEH	Class II	1996-06-21
K961197	Selectone Universal Plus Munro Laparoscopic Loop Electrode Model 60-5276 Series	Conmedcorp	GEI	Class II	1996-06-21
K961181	Nmi Vein Graft Perfusion Set	Naltiac Medical, Inc.	DTL	Class II	1996-06-21
K961180	Nmi Antegrad Cardioplegia Cannula	Naltiac Medical, Inc.	DWF	Class II	1996-06-21
K961174	ECG Monitor Model Ds-3130/3140	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1996-06-21
K961171	Humphrey Oct Scanner	Carl Zeiss, Inc.	HLI	Class II	1996-06-21
K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	MQV	Class II	1996-06-21
K960386	Handsafe	Handsafe Products Sdn. Bhd.	LYY	Class I	1996-06-21
K960303	Fenning Femoral Component	Zimmer GmbH	LPH	Class II	1996-06-21
K955648	K-Y Personal Lubricant	Ortho Pharmaceutical Corp.	HIS	Class II	1996-06-21
K955489	Calibration Serum Level 1 & 2	Randox Laboratories, Limited	JIX	Class II	1996-06-21
K954792	Lumiscope Model 2018 Thermometer	Lumiscope Co., Inc.	FLL	Class II	1996-06-21
K954514	Ua Perfect Automated Analysis Assay for Urobillinogen in Urine	SCITECK Diagnostics	KQO	Class I	1996-06-21
K953649	Disposable ECG Electrode	Kendall-Ltp	DRX	Class II	1996-06-21
K953551	Know-Recirc	H&H Control Systems	MQS	Class II	1996-06-21
K953211	Amylase (Ethylidene Pngpg7) Kit	Randox Laboratories, Limited	CIJ	Class II	1996-06-21
K950670	Immulite Herpes I and II Igg	Siemens Healthcare Diagnostics Inc.	LGC	Class II	1996-06-21
K962107	Ioves,cortina Club Eyewear,louttesrlg5	Leonachi, Inc.	HQY	Class I	1996-06-20
K960619	More-L Injector Kit Plus	Incutech, Inc.	CAZ	Class II	1996-06-20
K960401	Ultimate Seal	Hans Rudolph, Inc.	KGB	Class I	1996-06-20
K960370	Thyroglobulin Antibody Elisa	Immco Diagnostics, Inc.	JZO	Class II	1996-06-20
K960369	Thyroid Peroxidase Antibody Elisa	Immco Diagnostics, Inc.	JZO	Class II	1996-06-20
K955010	Autovac Bp Syste, 2000 Series	Boehringer Laboratories, LLC	CAC	Class II	1996-06-20
K954202	Platelet Function Test Assay Cartridges for the Hepcon Hms	Medtronic Hemotec, Inc.	JPA	Class II	1996-06-20
K952880	Model Lp-1000 Volume Ventilator	Aequitron Medical, Inc.	CBK	Class II	1996-06-20
K961870	Playtex Slimfit Tampons	Playtex Products, Inc.	HIL	Class II	1996-06-19
K961563	Ec-384Otl, Video Colonscope	Pentax Precision Instrument Corp.	FDF	Class II	1996-06-19
K961323	Lyofoam Extra C Odor Absorbing Wound Dressing	Acme United Corp.	KMF	Class I	1996-06-19