510(k) · Cleared
Clearedtwiist system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research & Development Corp. · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Apr 2, 2025 as substantially equivalent to K233952 (Deka Research and Development, 2024) after a 5-day review. Its family tree reaches back 3 generations to 2019. 1 later device descends from it.
- Decided
- Apr 2, 2025
- Review
- 5 days
- Class
- Class II
- Product code
- QFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180058 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 2 generations backK213536 DEKA ACE Pump SystemDeka Research and Development · 2023
- 1 generation backK233952 DEKA ACE Pump SystemDeka Research and Development · 2024
- This deviceK250930 twiist systemDeka Research & Development Corp. · 2025
- Descendant · cites it directly · 0 of its ownK261672 twiist Automated Insulin Delivery (AID) SystemDeka Research and Development · 2026
Most influential descendants
Showing 1 of 1 · See all- K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −2 | K213536 | DEKA ACE Pump System | Deka Research and Development | 2023 | — |
| −1 | K233952 | DEKA ACE Pump System | Deka Research and Development | 2024 | — |
| 0 (this device) | K250930 | twiist system | Deka Research & Development Corp. | 2025 | — |
| +1 | K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K233952 | DEKA ACE Pump SystemSummary page 5…II Device Panel: Clinical Chemistry Predicate Device The predicate device is the DEKA ACE Pump System, cleared under premarket notification K233952 on March 13, 2024. The predicate device has not been subject to a design-related recall. Device Description The twiist system de… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | 2026 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K261672 (Deka Research and Development, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K233952.
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. 2025, 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 twiist 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 6 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 twiist system is intended for single patient, home use and…
Read the full statement (116 words)
The twiist 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 6 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 twiist system 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 as stated in the FDA summary.
https://510kreport.com/device/K250930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250930: twiist system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250930
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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