DeviceClearance

Product code QJY— General Hospital

Remunity System

Classification name
Infusion Pump, Drug Specific, Pharmacy-Filled
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QJY under 21 CFR 880.5725, via openFDA

Market context for product code QJY

FDA has cleared 4 devices under product code QJY between 2020 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJY

Adverse events under product code QJY

product code QJY
Death
4
Other
1
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QJY

Data sourced from openFDA. This site is unofficial and independent of the FDA.