Class Class II
iLet® ACE Pump (K223846)
Description
iLet® ACE Pump by Beta Bionics, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223846
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeQFG
Regulation Number880.5730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223846
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. iLet® ACE Pump (K223846) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023 |
Trace the full predicate network for K223846
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.