
Medtronic Minimed
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SmartGuard Technology; Predictive Low Glucose Technology is an FDA 510(k)-cleared medical device (K253701) manufactured by Medtronic Minimed. 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 February 2, 2026. Regulation: 8.