FDA product code QFG: Alternate Controller Enabled Insulin Infusion Pump

QFG is the FDA product code for alternate controller enabled insulin infusion pump. It is a Class II device, regulated under 21 CFR 880.5730 and reviewed by the Clinical Chemistry panel. FDA has cleared 28 510(k) submissions under QFG, 26 in the last five years, from 9 different applicants. The average 510(k) review took 170 days (median 98); 100 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 21 recalls for QFG devices, 21 initiated in the last five years.

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.

Classification

510(k) clearances per year for QFG

Compare with all 510(k) review times · Search every QFG clearance

Top QFG applicants

4 more applicants have QFG clearances. See the full list in Caduvo.

Most recent QFG clearances

Recalls for QFG devices

21 product recalls in 19 recall events; 21 initiated in the last five years and 21 still open. Most recent: 2026-07-13.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• A4220 — Refill kit for implantable infusion pump

Frequently asked questions

What is FDA product code QFG?

QFG is the FDA product code for alternate controller enabled insulin infusion pump. It is a Class II device, regulated under 21 CFR 880.5730 and reviewed by the Clinical Chemistry panel.

What device class is QFG?

Class II, regulation 21 CFR 880.5730. Typical premarket route: 510(k).

How long does a 510(k) take for product code QFG?

Across 28 cleared submissions the average was 170 days from receipt to decision (median 98).

Which companies have the most QFG clearances?

Tandem Diabetes Care, Inc. (9); Beta Bionics, Inc. (5); Deka Research and Development (4); Medtronic Minimed, Inc. (3); Insulet Corporation (3).

Have QFG devices been recalled?

Yes: 21 product recalls across 19 recall events; the most recent began 2026-07-13.

Next steps

• Run an FDA pathway report with predicate devices for product code QFG
• Run a recall and safety report across every QFG manufacturer
• Watch product code QFG for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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