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Glucommander Plus

by Collaborativemed, LLC

510(k) K061110

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061110 Date7 Jun 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
NDC
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Glucommander Plus is a drug dose calculator classified as a Class II medical device under product code NDC. It is substantially equivalent to a predicate device and received FDA 510(k) clearance on June 7, 2006.

The device is manufactured by Collaborativemed, LLC located at 14-D Pelham Ridge Dr., Greenville, SC 29615. It is regulated under regulation number 868.1890 and falls within the anesthesiology medical specialty.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Glucommander Plus used for?

    Glucommander Plus is a drug dose calculator designed to assist in calculating drug doses, specifically within the anesthesiology medical specialty as indicated by its product code NDC and regulation number 868.1890.

  • How is Glucommander Plus supplied or accessed?

    The device is a software-based drug dose calculator manufactured by Collaborativemed, LLC, and is accessed as a Class II medical device under FDA 510(k) clearance K061110, though specific delivery format (e.g., standalone software, integrated system) is not detailed in the provided data.

  • Is Glucommander Plus sterile or single-use?

    As a drug dose calculator, Glucommander Plus is not a physical implant or disposable item; it is a reusable software tool for dose calculation, so sterility and single-use designations do not apply to its function as a computational aid.

  • What regulatory pathway was used for Glucommander Plus?

    Glucommander Plus received FDA 510(k) clearance via the traditional pathway on June 7, 2006, under K-number K061110, demonstrating substantial equivalence to a predicate device in the Class II drug dose calculator category.