SteadiSet infusion set
FDA 510(k) K251854 · Tandem Diabetes Care
510(k) numberK251854
Submission
- Device name
- SteadiSet infusion set
- Applicant
- Tandem Diabetes Care
San Diego, CA, US - Received
- June 17, 2025
- Decision date
- August 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | Icu Medical, Inc. | 06/05/2025SE |
More from Icu Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260429 | Control-IQ+ technologyQJI · Traditional | 04/24/2026SE |
| K253074 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 11/06/2025SE |
| K250792 | t:slim X2 insulin pump with interoperable technologyQFG · Traditional | 09/24/2025SE |
| K250798 | Control-IQ+ technologyQJI · Traditional | 05/21/2025SE |
| K243823 | Control-IQ+ technologyQJI · Traditional | 02/24/2025SE |
| K241078 | Tandem Mobi Insulin Pump with interoperable technologyQFG · Traditional | 07/26/2024SE |
| K240309 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 03/21/2024SE |
| K232382 | Control-IQ TechnologyQJI · Traditional | 11/03/2023SE |
| K232380 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Traditional | 11/03/2023SE |
| K233044 | Tandem Mobi insulin pump with interoperable technologyQFG · Special | 10/05/2023SE |
Questions and answers
When was SteadiSet infusion set cleared by the FDA?
SteadiSet infusion set (K251854) received a 510(k) decision of Substantially Equivalent on August 6, 2025, 50 days after the submission was received.
What is the product code of K251854?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.