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 1477 of 3531

510(k) clearances, page 1477 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022917	Home Care Various Models of Self-Adhesive Electrodes	Home Care Technology Co., Ltd.	GXY	Class II	2003-03-04
K021878	Eska Modular Hip System Acetabular Components	Eska America Corp.	LPH	Class II	2003-03-04
K030524	Cd Leycom 7 Fr Pressure/volume Catheter (10 Mm Electrode Spacing) Pressure/volume Combination Catheter with Lumen	CD Leycom	OBJ	Class II	2003-03-03
K030492	Titanium Ossicular Replacment System	Invotec International, Inc.	ETA	Class II	2003-03-03
K030452	Bayer Ligand Plus 1, 2, 3 Controls	Bayer Diagnostics Corp.	JJY	Class I	2003-03-03
K030380	Tissuelink Sealing Forceps, Model 1 21-202-1	Medtronic Navigation, Inc	GEI	Class II	2003-03-03
K030335	On-Line Powder-Free Nitrile Examination Glove, Violet Colored	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	2003-03-03
K030163	Aseptico Vct Versatile Command Technology Model Aeu-925	Aseptico, Inc.	EKX	Class I	2003-03-03
K024338	Powder Free Vinyl Exam Gloves with Aloe Coating Inside	General Gloves Corp.	LYZ	Class I	2003-03-03
K024290	Promotor Final Rinse Sperm Wash Medium	Ceres Fertility, Inc.	MQL	Class II	2003-03-03
K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents	Precision Systems, Inc.	CDQ	Class II	2003-03-03
K024062	Ascensia Breeze Blood Glucose Meter	Bayer Corp.	CGA	Class II	2003-03-03
K024004	Xive Transgingival Dental Implant System	Friadent GmbH	DZE	Class II	2003-03-03
K023997	Tenscare Ultima Nms/ems	Tenscare Ltd.	IPF	Class II	2003-03-03
K023796	Ms Paed-Baby Body	Erich Jaeger, Inc.	CCM	Class II	2003-03-03
K023348	Midmark M9 Ultraclave Steam Sterilizer	Midmark Corp	FLE	Class II	2003-03-03
K023082	Babycare	Bionet Co., Ltd.	HEP	Class II	2003-03-03
K021537	Multipurpose Neuroplus Electrode, Model A10005	Vermont Medical, Inc.	GXY	Class II	2003-03-03
K030091	Bd Phoenix Automated Microbiology System - Norfloxacin 0.25 - 16 Ug/ml	Lee Laboratories, Inc.	LON	Class II	2003-02-28
K024091	Silk Sutures	Aurolab	GAP	Class II	2003-02-28
K024090	Nylon Suture	Aurolab	GAR	Class II	2003-02-28
K023985	Acidified Component Concentrates for Bicarbonate Dialysis Containing Di-Acetate	Rockwell Medical	KPO	Class II	2003-02-28
K023690	Catheter Connector	World Metals, Inc.	KNY	Class II	2003-02-28
K023455	Aosept Clear Care Cleaning and Disinfecting Solution	Alcon Laboratories	MRC	Class II	2003-02-28
K023083	Silberg T.p.s., Tissue Preparation System, Model Me 800	Mettler Electronics Corp	FRN	Class II	2003-02-28
K030406	Nitrile Powder Free Exam Glove, with Peppermint Flavor	Pt. Smartglove Indonesia	LZA	Class I	2003-02-27
K030324	Radiant Innovation Inc. Infrared Ear Thermometer, Models Th1 Series	Radiant Innovation Inc.	FLL	Class II	2003-02-27
K030315	Modification to Ultroid Hemorrhoid Management System	Ultroid, LLC	KNS	Class II	2003-02-27
K030112	Powder Free Latex Examination Gloves with Protein Labeling Claim Less Than 50 Microgram or Less of Total Water Extractab	Pt. Smartglove Indonesia	LYY	Class I	2003-02-27
K030004	0.55% Orth-Phthalaldehyde Solution	Advanced Sterilization Products	MED	Class II	2003-02-27
K024216	Top Glove Vinyl Examination Glove	Top Glove (Zhangjiagang) Co., Ltd.	LYZ	Class I	2003-02-27
K024079	Alibi Biological Indicator, Model Ws	Arden Laboratories, Incorporated	FRC	Class II	2003-02-27
K024050	Cook Nephrostomy Dilation Balloon Catheter Set	Cook Incorporated	LJE	Unclassified	2003-02-27
K023973	Automed 3200 Infusion Pump	Help Technologies	FRN	Class II	2003-02-27
K023966	Disposable Bi-Polar Cable	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2003-02-27
K022980	Modification to Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2003-02-27
K022388	Startox Drug of Abuse Screening Test (4)	Starplex Scientific Corp.	DJC	Class II	2003-02-27
K030473	Senorx Es-300	Senorx, Inc.	GEI	Class II	2003-02-26
K030463	Modification to the Maestro System	BioHorizons Implant Systems Inc	DZE	Class II	2003-02-26
K030431	Modification to Dash 3000/4000 Patient Monitor	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-02-26
K030383	Modification to Moss Miami Spinal System Polyaxial Screws	Depuyacromed	MNH	Class II	2003-02-26
K030327	Zephir Anterior Cervical System	Medtronic Sofamor Danek	KWQ	Class II	2003-02-26
K030311	Hem-O-Lok Xl Clip	Weck	FZP	Class II	2003-02-26
K030289	Hermetic Plus External Csf Drainage Systems, Ins-8301,Ins-8302,Ins-8700, Nl850-830N	Integra LifeSciences Corporation	JXG	Class II	2003-02-26
K030264	Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030	Jostra AG	DTZ	Class II	2003-02-26
K030254	Interferential Stimulator, Model Rtm1000	Ryan Telemedicine	IPF	Class II	2003-02-26
K030246	Victus i.v. Administration Set, Models 27071 and 27072	Victus, Inc.	FPA	Class II	2003-02-26
K030178	Calcigen Psi Bone Graft Substitute	Zimmer GmbH	MQV	Class II	2003-02-26
K030141	Modification to Cardiovention Powerbase Console, Model Pcb-100	Cardiovention, Inc.	DTQ	Class II	2003-02-26
K030054	Disposable Vitrectomy Sets, Disposable Virectomy Lenses	Fci Ophthalmics, Inc.	HJK	Class II	2003-02-26