# Clarius Bladder AI

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

- Canonical page: <https://devicerts.com/devices/clarius-bladder-ai-qih>
- Manufacturer: [Clarius Mobile Health Corp.](https://devicerts.com/manufacturers/fda-fei-3012747207) (Canada)
- Device class: Class II (US FDA)
- FDA product code: QIH

## Overview

*AI-generated summary, 2026-09-26. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

Clarius Bladder AI is a noninvasive tool designed to automatically measure bladder volume. It identifies and highlights the bladder to deliver calculations that support clinical decision-making and interventions.

This device has received 510(k) clearance from the U.S. FDA. It is intended for use in settings such as hospitals, clinics, and nursing homes to assist in the assessment of bladder volume.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K232257 · decision 2023-11-13 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K232257 [FDA 510(k)]
- FDA product code: QIH [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Clarius Bladder AI, Clarius Mobile Health Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/clarius-bladder-ai-qih (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/clarius-bladder-ai-qih.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/clarius-bladder-ai-qih
- 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.