510(k) · Cleared
ClearediLet® ACE Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beta Bionics, Inc. · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on May 19, 2023 as substantially equivalent to K201214 (Tandem Diabetes Care, Inc., 2020) after a 150-day review. Its family tree reaches back 2 generations to 2019. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 19, 2023
- Review
- 150 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, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 1 generation backK201214 t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Recalled (Class I)
- This deviceK223846 iLet® ACE PumpBeta Bionics, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK231485 iLet® ACE PumpBeta Bionics, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK252770 iLet ACE PumpBeta Bionics, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK253976 iLet ACE PumpBeta Bionics, Inc. · 2026
Class I recalls in this family
- K201214 t:slim X2 Insulin Pump with Interoperable…direct predicate · 2020
Most influential descendants
Showing 3 of 3 · See allView 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 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | Class I |
| 0 (this device) | K223846 | iLet® ACE Pump | Beta Bionics, Inc. | 2023 | — |
| +1 | K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023 | 1 |
| +2 | K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025 | 2 |
| +3 | K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K201214 | t:slim X2 Insulin Pump with Interoperable TechnologySummary page 4…e: Alternate controller enabled infusion pump (21 CFR 880.5730, QFG) Predicate Devices t:slim X2 insulin pump with interoperable technology (Tandem Diabetes Care, Inc., K201214) Description of the iLet ACE Pump The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin un… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231485 | iLet® ACE Pump | 2023 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K231485 (Beta Bionics, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K201214.
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. 2023, 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 iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (iCGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223846: iLet® ACE Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223846
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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