QJY

Infusion Pump, Drug Specific, Pharmacy-Filled

Product code
QJY
Device name
Infusion Pump, Drug Specific, Pharmacy-Filled
Device class
Class 2
21 CFR
21 CFR 880.5725
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

FDA classification definition

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-11-27.

NumberDecision dateApplicantDevice nameSummary
K2433542024-11-27Deka Research & Development Corp.Remunity SystemPDF
K2402562024-06-12Deka Research and DevelopmentRemunity SystemPDF

2 summaries are archived here for direct download.

Official FDA classification page: QJY
Classification and pathway per current FDA publications. Data from openFDA (CC0).