Cleared Abbreviated

SteadiSet infusion set

K251854 · Tandem Diabetes Care · Chemistry

Aug 2025

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K251854 is an FDA 510(k) clearance for the SteadiSet infusion set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Tandem Diabetes Care (San Diego, US). The FDA issued a Cleared decision on August 6, 2025, 50 days after receiving the submission on June 17, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251854 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2025
Decision Date	August 06, 2025
Days to Decision	50 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF