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SmartGuard Technology

by Medtronic Minimed, Inc.

510(k) K261962

SmartGuard Technology is a Class II device made by Medtronic Minimed, Inc., cleared under FDA 510(k) K261962 on 9 Jul 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK261962 Date9 Jul 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QJI
FDA applicant
Medtronic MiniMed
Device class
Class II
Regulation
21 CFR Part 862.1356
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

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Other devices filed under FDA product code QJI (Interoperable Automated Glycemic Controller).

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