# EndoTool IV Cloud 1.0

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc>
- Manufacturer: [Glooko, Inc.](https://devicerts.com/manufacturers/glooko-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: NDC

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K260910 · decision 2026-05-01 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K260910 [FDA 510(k)]
- FDA product code: NDC [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 868.1890 [FDA 510(k)]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: EndoTool IV Cloud 1.0, Glooko, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/endotool-iv-cloud-1-0-ndc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.
