# K213536: DEKA ACE Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Jul 25, 2023 after 627 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180058 (2019). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180058: t:slim X2 insulin pump with interoperable technology, Tandem Diabetes Care, Inc. (2019) Summary page 4.

## Most influential descendants
- K233952: DEKA ACE Pump System (2024), 3 descendants of its own
- K250930: twiist system (2025), 1 descendant of its own
- K261672: twiist Automated Insulin Delivery (AID) System (2026), 0 descendants of its own
- K241178: DEKA ACE Pump System (2024), 0 descendants of its own

## Indications for use
The DEKA ACE Pump System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 13 and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription. The bolus calculator is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator-entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

Source page: https://510kreport.com/device/K213536
Methodology: https://510kreport.com/methodology