Class Class II
Tidepool Loop (K203689)
Description
Tidepool Loop by Tidepool Project, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK203689
Clearance Date2023-01-23
Clearance TypeTraditional
Product CodeQJI
Regulation Number862.1356
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K203689
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. Tidepool Loop (K203689) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234055 | DEKA Loop | Deka Research and Development | 2024 |
Trace the full predicate network for K203689
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.