510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QJYClass II

Infusion Pump, Drug Specific, Pharmacy-Filled

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

QJY is the FDA product code for Infusion Pump, Drug Specific, Pharmacy-Filled, a class II device type, regulated under 21 CFR 880.5725. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QJY
Device name
Infusion Pump, Drug Specific, Pharmacy-Filled
FDA 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.
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QJY

By decision year
4 clearances under product code QJY with a decision year between 2020 and 2024, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QJY by decision year
YearClearances
20202
20242

Applicants with the most clearances

Product code QJY
Applicants holding the most 510(k) clearances under product code QJY
ApplicantClearances
Deka Research & Development Corp.4

Companies listing this code with FDA

Companies whose registered establishments list this code