FDA 510(k)

Glucommander

K-Number: K254102 · 2026-05-27

Decision Date2026-05-27

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Glucommander is the device name listed in this FDA 510(k) record. The listed applicant is Glytec, LLC. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254102. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glucommander?

Glucommander is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Glytec, LLC. The 510(k) number is K254102.

When did Glucommander receive FDA 510(k) clearance?

Glucommander received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254102.

Who is the listed applicant for Glucommander?

The FDA 510(k) record lists Glytec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glucommander?

The FDA product code for Glucommander is NDC.

Other records listing Glytec, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152300Glucommander

Related Devices (Code: NDC)

K260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic Minimed K253281UpDocUpdoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.