Tandem Diabetes Care Receives FDA Clearance for SteadiSet Infusion Set

Strategic Insights -

Tandem Diabetes Care Inc. has announced that its SteadiSet Infusion Set has received 510(k) clearance from the United States Food and Drug Administration (FDA) for up to three days of use. This wearable infusion set is designed to provide adult patients with Type 1 diabetes continuous insulin delivery during the indicated use period. The clearance was granted on May 9, 2025, following a submission made by Capillary Biomedical, LLC, a wholly owned subsidiary of Tandem Diabetes Care.

Key Takeaways:

  • SteadiSet Infusion Set has received 510(k) clearance from the FDA for up to three days of use, with commercial activities anticipated to start after FDA clearance for extended use time.
  • The SteadiSet Infusion Set features an integrated inserter with a hidden needle designed for one-handed insertion and is designed to provide continuous insulin delivery to adult patients with Type 1 diabetes.
  • Tandem Diabetes Care, Inc. intends to submit a separate 510(k) notification to the FDA to extend the indicated use time of SteadiSet to up to seven days.
  • Capillary Biomedical, LLC, a wholly owned subsidiary of Tandem Diabetes Care, made the submission to the FDA for the initial 510(k) clearance.
  • Tandem Diabetes Care has filed a Form 8-K with the U.S. Securities and Exchange Commission, noting the receipt of 510(k) clearance for SteadiSet Infusion Set.

Statistics:

  • 510(k) clearance granted: May 9, 2025
  • Indicated use period for SteadiSet Infusion Set: up to three days
  • Number of patients expected to benefit from SteadiSet Infusion Set: adult patients with Type 1 diabetes

Sources:

  • Tandem Diabetes Care Inc. at the U.S. Securities and Exchange Commission (USTANDDEMER_SOCKET_DIA BATERIESIPSECONCPACCAFAPen IP intended Use)
  • Tandem Diabetes Care Inc. at capbio.com