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 3104 of 3528

510(k) clearances, page 3104 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834566	Preserv Saf Fixative 15Ml	Preventive Diagnostics Corp.	LIO	Class I	1984-02-04
K834510	Renaflo Avf Set for Hemodialysis	Renal Systems, Inc.	KNZ	Class II	1984-02-04
K834504	Eska Jonas Silicon-Silver Penile	Dacomed Corp.	FAE	Class II	1984-02-04
K834480	Injection Cap	BD Becton Dickinson Vacutainer Systems Preanalytic	FOZ	Class II	1984-02-04
K834476	Nephrostomy/biliary Drainage Bag	Vertex Medical Corp.	LJE	Unclassified	1984-02-04
K834459	Diagnostic Radiology Catheters	American Edwards Laboratories	DQO	Class II	1984-02-04
K834451	Coaxial Balloon Gastroesophageal Dila	Thomas J. Fogarty, M.D.	KNQ	Class II	1984-02-04
K834440	Injection Aide Unit for Diagetics	Gottinger Co.	KZH	Class II	1984-02-04
K834438	Temperature Sensing Foley Catheter	C.R. Bard Inc	KOD	Class II	1984-02-04
K834414	Ercp Cannula	Hobbs Medical, Inc.	ODD	Class II	1984-02-04
K834403	Injection Needle	Bobbs Medical, Inc.	FBK	Class II	1984-02-04
K834402	Gastrointestinal Sheath Brush	Hobbs Medical, Inc.	FDX	Class II	1984-02-04
K834373	Cardiotomy Reservors Bcr-3000/3500-Q-120	American Bentley	DTN	Class II	1984-02-04
K834346	Bhcg-Check	Diagnostic Technology, Inc.	JHJ	Class II	1984-02-04
K834342	Ccs Model Av-102 Implantable a-V Data	Cardiac Control Systems, Inc.	DTB	Class III	1984-02-04
K834301	Thrombolytic Activity Test	Bio/Data Corp.	GJA	Class II	1984-02-04
K834296	Adult Incontinence Brief	Procter & Gamble Mfg. Co.	EYQ	Class I	1984-02-04
K834295	Adult Incontinence Pad	Procter & Gamble Mfg. Co.	EYQ	Class I	1984-02-04
K834290	Inspiron Liquid Oxygen System	Inspiron Corp.	BYJ	Class II	1984-02-04
K834275	Softip Catheter	Angiomedics, Inc.	DQO	Class II	1984-02-04
K834268	Islami Gastrointestinal Tube	Biosearch Medical Products, Inc.	KNT	Class II	1984-02-04
K834262	Trans-Pace	Micromedical Devices, Inc.	DRO	Class II	1984-02-04
K834258	Hodge Decompression Tube	Inmed Corp.	KNT	Class II	1984-02-04
K834246	Progesterone Test Set 125I 17-Oh	Wien Laboratories, Inc.	JLX	Class I	1984-02-04
K834237	Graduated Guide Wire Bowl 8	Sterile Design, Inc.	DQX	Class II	1984-02-04
K834219	Phase II Cortisol Kit	Medical & Scientific Designs, Inc.	CGR	Class II	1984-02-04
K834110	Antense Anti-Tension Device	Bio Sig Instruments, Inc.	HCC	Class II	1984-02-04
K834109	Mahurkar Dual Limen Femoral Catheter	Quinton, Inc.	DQY	Class II	1984-02-04
K834084	Hydroxybutyrate Dehydrogenase Reagent	Sterling Biochemical, Inc.	JKF	Class I	1984-02-04
K834080	Matched Component Set for Digitoxin	Cambridge Medical Technology	LCW	Class II	1984-02-04
K834062	Sterile Labels	Devon Industries, Inc.	LDQ		1984-02-04
K834060	Reliance Ophthalmic Slit Lamp R-083	F. & F. Koenigkramer	HQF	Class II	1984-02-04
K834057	Il 301 Portable Transcut. Oxygen Moni	Instrumentation Laboratory Co.	KLK	Class II	1984-02-04
K834054	Dart Gamma-Gt Reagent System	Coulter Electronics, Inc.	JQB	Class I	1984-02-04
K834053	Dart Alpha-Amylase Reagent System	Coulter Electronics, Inc.	CIJ	Class II	1984-02-04
K834051	Protopath Factor VIII Assay	American Dade	GGP	Class II	1984-02-04
K834050	Protopath Factor IX Assay	American Dade	GGP	Class II	1984-02-04
K833976	Vanish	Parke-Davis Co.	KGO	Class I	1984-02-04
K833947	Superior Enternal Feeding System	Superior Plastic Products Corp.	KNT	Class II	1984-02-04
K833924	Two Channel Gastrofiberscope Fg-36T	Pentax Precision Instrument Corp.	FDS	Class II	1984-02-04
K833908	Irri-Cath	Abbott Medical	BSY	Class I	1984-02-04
K833872	Sav-a-Limb	Sil-Med Corp.	KYR	Class I	1984-02-04
K833856	C-Loops	Concept, Inc.			1984-02-04
K833853	T3 Ria	Syncor Intl. Corp.	CDP	Class II	1984-02-04
K833836	Il Heparinized Flow Directed Thermal	Instrumentation Laboratory Co.	DYG	Class II	1984-02-04
K833555	Lal Test Release & Bonchek Car/jacket	Shiley, Inc.	DTR	Class II	1984-02-04
K833532	Oculase 514 Ophthalmic Argon Laser	Lasermed Corp.	HQF	Class II	1984-02-04
K833311	Nitroglycerine Container	Apothecary Products, LLC	NXB	Class I	1984-02-04
K833231	Sound Imager I	Sound Imaging, Inc.	IYO	Class II	1984-02-04
K833193	Radioimmunoassay, Thyroid Stimu. Hormone	Biosan Laboratories, Inc.	JLW	Class II	1984-02-04