Glucommander— 510(k) K261939
Substantially EquivalentGlytec, LLC
FDA 510(k) clearance K261939 for Glucommander, Substantially Equivalent on 2026-10-05. Applicant: Glytec, LLC. Device class: 2.
Summary
Glucommander from Glytec is filed under NDC, drug dose calculators. The record doesn't say which drugs it calculates doses for.
Class II, 21 CFR 868.1890. The Clinical Chemistry review panel handled it as a Traditional 510(k); the record lists Anesthesiology as the classification panel.
Glytec filed from Greenville, South Carolina. Review took 117 days (June 10 to October 5, 2026).
Clearance details
- Applicant
- Glytec, LLC
- Product code
- Product code NDC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenville, SC, US
Recent devices under product code NDC
view allMore clearances from Glytec, LLC
view allAdverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.