Class Class II
SteadiSet infusion set (K251854)
Description
SteadiSet infusion set by Tandem Diabetes Care, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251854
Clearance Date2025-08-06
Clearance TypeAbbreviated
Product CodeFPA
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251854
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. SteadiSet infusion set (K251854) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025 |
Trace the full predicate network for K251854
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.