FDA 510(k)

SteadiSet infusion set

Número K: K251854 · 2025-08-06

Data da decisão2025-08-06

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the SteadiSet infusion set?

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

When did SteadiSet infusion set receive FDA 510(k) clearance?

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

Who is the listed applicant for SteadiSet infusion set?

The FDA 510(k) record lists Tandem Diabetes Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteadiSet infusion set?

The FDA product code for SteadiSet infusion set is FPA.

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