FDA 510(k)

SteadiSet infusion set

K-Number: K251854 · 2025-08-06

Decision Date2025-08-06

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SteadiSet infusion set is a medical device manufactured by Tandem Diabetes Care. It received FDA 510(k) clearance on 2025-08-06 under approval number K251854. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SteadiSet infusion set?

SteadiSet infusion set is a medical device that received FDA 510(k) clearance on 2025-08-06. It is manufactured by Tandem Diabetes Care. The 510(k) number is K251854.

When was SteadiSet infusion set approved by the FDA?

SteadiSet infusion set received FDA 510(k) clearance on 2025-08-06, under approval number K251854.

What company makes SteadiSet infusion set?

SteadiSet infusion set is manufactured by Tandem Diabetes Care.

What is the FDA product code for SteadiSet infusion set?

The FDA product code for SteadiSet infusion set is FPA.

Related Clinical Trials

NCT06024928 Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes COMPLETED

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.