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

Alternate Controller Enabled Insulin Infusion Pump

21 CFR 880.5730 / Clinical Chemistry
FDA source (opens on fda.gov)

QFG is the FDA product code for Alternate Controller Enabled Insulin Infusion Pump, a class II device type, regulated under 21 CFR 880.5730. FDA's definition for this code reads: "An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices...". As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
QFG
Device name
Alternate Controller Enabled Insulin Infusion Pump
FDA definition
An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.
Regulation
21 CFR 880.5730
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
29
Ingested recalls
22

Clearances, product code QFG

By decision year
29 clearances under product code QFG with a decision year between 2019 and 2026, 2023 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code QFG by decision year
YearClearances
20192
20201
20222
20239
20245
20255
20265

Applicants with the most clearances

Product code QFG
Applicants holding the most 510(k) clearances under product code QFG
ApplicantClearances
Tandem Diabetes Care, Inc.10
Deka Research & Development Corp.5
Beta Bionics, Inc.4
Insulet Corporation3
Medtronic, Inc.3
Beta Bionics, Inc.1
embecta medical I LLC1
Roche Diabetes Care, Inc.1
Triple Jump Israel, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order