
Tandem Diabetes Care, Inc.
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t:slim X2 insulin pump with interoperable technology is an FDA 510(k)-cleared medical device (K250792) manufactured by Tandem Diabetes Care, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 2025. Regulation: 8.