510(k) · Cleared
ClearedDEKA ACE Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research and Development · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Mar 13, 2024 as substantially equivalent to K213536 (Deka Research and Development, 2023) after an 89-day review. Its family tree reaches back 2 generations to 2019. 3 later devices descend from it.
- Decided
- Mar 13, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- QFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180058 (2019). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 1 generation backK213536 DEKA ACE Pump SystemDeka Research and Development · 2023
- This deviceK233952 DEKA ACE Pump SystemDeka Research and Development · 2024
- Descendant · cites it directly · 1 of its ownK250930 twiist systemDeka Research & Development Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK261672 twiist Automated Insulin Delivery (AID) SystemDeka Research and Development · 2026
- Descendant · cites it directly · 0 of its ownK241178 DEKA ACE Pump SystemDeka Research and Development · 2024
Most influential descendants
Showing 3 of 3 · See all- K250930twiist systemDeka Research & Development Corp. · 2025 · cites it directly1descendant
- K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development · 2026 · 2 generations on0descendants
- K241178DEKA ACE Pump SystemDeka Research and Development · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −1 | K213536 | DEKA ACE Pump System | Deka Research and Development | 2023 | — |
| 0 (this device) | K233952 | DEKA ACE Pump System | Deka Research and Development | 2024 | — |
| +1 | K250930 | twiist system | Deka Research & Development Corp. | 2025 | — |
| +2 | K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026 | — |
| +1 | K241178 | DEKA ACE Pump System | Deka Research and Development | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFG device
- #1 K251032 MiniMed 780G insulin pumpscore 19.6 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213536 | DEKA ACE Pump SystemSummary page 4…: QFG Class: II Device Panel: Clinical Chemistry Predicate Device The predicate device for this submission is the DEKA ACE Pump System cleared on 7/25/2023 under 510(k) K213536. Device Description The DEKA ACE Pump system is a modification of the previously cleared DEKA ACE Pump System (K213536). The mo… | 2023 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250930 (Deka Research & Development Corp., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QFG devicesQFG Alternate Controller Enabled Insulin Infusion Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QFG
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFG
44in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFG
8so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · QFG
324,360in 2025
MAUDE reports naming product code QFG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 30,522 |
| 2021 | 0 | — | 0 | 74,701 |
| 2022 | 2 | — | 1 | 129,119 |
| 2023 | 9 | 150 | 1 (1) | 188,014 |
| 2024 | 5 | 89 | 0 | 273,180 |
| 2025 | 5 | 44 | 3 (1) | 324,360 |
| 2026 | 6 | 103 | 8 (1) | — |
What is it indicated for?
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 six 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…
Read the full statement (117 words)
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 six 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233952 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233952: DEKA ACE Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233952
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026