MiniMed Quick-serter— 510(k) K160860

Clearance details

Applicant

Medtronic Minimed

Product code

Code KZH

Device class

Class 2

Regulation

21 CFR 880.6920

Advisory panel

General Hospital

Date received

2016-03-29

Decision date

2016-09-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northridge, CA, US

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• K253701 — SmartGuard Technology; Predictive Low Glucose Technology2026-02-03
• K253512 — MiniMed Go App2026-01-08
• K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))2024-11-12
• K241622 — Extended Reservoir; MiniMed Reservoir2024-07-02

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →