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 2026-11-02, 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 2400 of 3531

510(k) clearances, page 2400 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910727	Excel Model 2110	Excel Medical Systems, Inc.	GZJ	Class II	1992-01-17
K910624	Case IV Computer Aided Sensory Evaluator Version 4	WR Medical Electronics Co.	LLN	Class I	1992-01-17
K902433	Dia Anatomic Abutment	Dental Imaging Assoc., Inc.	DZE	Class II	1992-01-17
K895901	Vita Cerec Set and Vita Cerec Blocs	Vident	ELW	Class II	1992-01-17
K915692	Cannulated Drill Bit	W. L. Gore & Associates, Inc.	HTW	Class I	1992-01-16
K915581	Codman Sof'wire (Tm) Kit	Cerenovus, Inc.	JDQ	Class II	1992-01-16
K914695	Global Total Shoulder	Depuy, Inc.	KWT	Class II	1992-01-16
K914694	Sterile View(tm) Hi Effic Helmet/back Pk Sup/exhau	Depuy, Inc.	JCX	Class II	1992-01-16
K914558	Traumafix (Tm) External Fixator	Synthes (USA) Products LLC	KTT	Class II	1992-01-16
K913814	Model #05 Aneroid Sphygmomanometer Kit	National Health-Care Equipment, Inc.	ELY	Class II	1992-01-16
K913561	Luque Segmental Spinal Instrumentation	Zimmer GmbH	KWP	Class II	1992-01-16
K913420	Zirconia Ceramic Modular Heads(type I Taper) Modif	Zimmer GmbH	LZO	Class II	1992-01-16
K910986	Hoffmann Dynamic Wrist Fixator	Howmedica Corp.	KTT	Class II	1992-01-16
K915732	Abbott Quickstart Tiglycerides Reagent	Em Diagnostic Systems, Inc.	CDT	Class I	1992-01-15
K915464	Digitoxin Fpia Calibrator Set	Sigma Diagnostics, Inc.	DLJ	Class II	1992-01-15
K915346	Custom Canal Hearing Aid	Dicta Laboratories	ESD	Class I	1992-01-15
K915265	Cdi(tm) H/s Cuvette, Modification	3M Company	DRY	Class II	1992-01-15
K915255	Cdi(tm) 300, 400 & 100, Modification	3M Company	DRY	Class II	1992-01-15
K915239	Endopath Disposable Trocar Sleeve W/dilating Obtur	Ethicon, Inc	GCJ	Class II	1992-01-15
K915176	Nova 4 Na/k/c1/tco2/li Analyzer	Nova Biomedical Corporation	JGS	Class II	1992-01-15
K914869	Marlow Laparoscopic Scissors	Marlo Surgical Technology	GCJ	Class II	1992-01-15
K914857	Cedia(r) Carbamazepine Assay	Microgenics Corporation	KLT	Class II	1992-01-15
K914853	Antinuclear Antibody (Ana) Screening Test Kit	Reads Medical Products, Inc.	LJM	Class II	1992-01-15
K914818	Dade(r) Alpha 2 Antiplasmin(2 2-Ap) Chromo Assay	Baxter Diagnostics, Inc.	GGP	Class II	1992-01-15
K914792	Pn 62290 0.22 Micron Micro Infus i.v. Exten Set	Filtertek, Inc.	FPA	Class II	1992-01-15
K914756	Ultrasensitive Tsh (U-Tsh) Enzyme Immuno Test Kit	Medix Biotech, Inc.	JLW	Class II	1992-01-15
K914691	Individual/large/belt First Aid Kits	Lighthouse for the Blind	LYY	Class I	1992-01-15
K914605	Multiple Sterile Surgical Drape Pack	Assured Surgical Products, Inc.	KKX	Class II	1992-01-15
K914429	Dsl Ultra-Sensitive Calcitonin Ria (Dsl 5200)	Diagnostic Systems Laboratories, Inc.	JKR	Class II	1992-01-15
K914155	Tia Crp Test Kit	Crestat Diagnostics, Inc.	DCK	Class II	1992-01-15
K913809	Hy-Prep System	Hyperion, Inc.	JQW	Class I	1992-01-15
K913784	Dobbhoff(r) Single Pass Peg Kit	Biosearch Medical Products, Inc.	KNT	Class II	1992-01-15
K913308	Ivex-Tpn Extension Filter Set	Abbott Medical	FPB	Class II	1992-01-15
K913216	Trach T Adapter	Specialty Packaging Producs, Inc.	BZA	Class I	1992-01-15
K913164	Non Rebreathing Mask	Specialty Packaging Producs, Inc.	KGB	Class I	1992-01-15
K912946	Collins Digital Pulmonary Manometer	Warren E. Collins, Inc.	BXR	Class II	1992-01-15
K912805	Pari-Master	Paul Ritzau Pari GmbH	CAF	Class II	1992-01-15
K912760	Ad-Tech Epidural Peg Electrode	AD-Tech Medical Instrument Corp.	GYC	Class II	1992-01-15
K911776	Dpi-1106 Implant, Modification	Minimatic Implant Technology	DZE	Class II	1992-01-15
K910994	Modified Seismocardiograph	Seismed Instruments, Inc.	DSB	Class II	1992-01-15
K915784	Intersegmental Traction Table	TJN Manufacturing,Inc.	JFB	Class II	1992-01-14
K915417	Kopan's Target	Medical Device Technologies, Inc.	GAA	Class I	1992-01-14
K915382	Amoena Affinity Model #802	MEDLINE INDUSTRIES, LP - Northfield	KCZ	Class I	1992-01-14
K915333	Electrode Using Promeon Rg-60 Series Gel	Labeltape Meditect, Inc.	GXY	Class II	1992-01-14
K915005	Photac-Bond Aplicap, Modification	Espe GmbH (US)	EMA	Class II	1992-01-14
K914591	L.c.s. 2000 System	Stiefel Research Institute, Inc.	GEH	Class II	1992-01-14
K913966	Sono(r) -Cem	Espe GmbH (US)	EBF	Class II	1992-01-14
K913854	Ortho Light Cure	Ortho Source	DYH	Class II	1992-01-14
K913651	Mani Dia-Burs	The Lahr Consulting Group, Inc.	DZP	Class I	1992-01-14
K910742	Medi-Trace Disposable Intrauterine Catheter	Graphic Controls Corp.	KXO	Class II	1992-01-14