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EndoTool IV Cloud 1.0

by Glooko, Inc.

510(k) K260910

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 · Traditional NumberK260910 Date1 May 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  • Withdrawn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
NDC
Device class
Class II
Regulation
21 CFR Part 868.1890
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

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

The EndoTool IV Cloud 1.0 is a Calculator, Drug Dose (FDA regulation 868.1890), designed to assist in the precise calculation and administration of intravenous drug dosages. This digital tool supports anesthesiology workflows by automating calculations to enhance patient safety and reduce human error during critical procedures.

Supplied as a cloud-based software solution, the EndoTool IV Cloud 1.0 is intended for single-use per session and does not require physical sterilization. It operates within Class 2 regulatory standards and has received FDA 510(k) clearance under the Traditional pathway (K260910). No MRI safety or physical size specifications are noted in the regulatory submission.

Similar devices

Other devices filed under FDA product code NDC (Calculator, Drug Dose).

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