Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1900](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1900) → PHZ — Abnormal Breath Sound Device

# PHZ · Abnormal Breath Sound Device

_Anesthesiology · 21 CFR 868.1900 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ

## Overview

- **Product Code:** PHZ
- **Device Name:** Abnormal Breath Sound Device
- **Regulation:** [21 CFR 868.1900](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1900)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243567](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K243567.md) | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | Apr 7, 2025 | SESE |
| [K240555](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K240555.md) | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | Jul 2, 2024 | SESE |
| [K232237](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K232237.md) | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | Dec 13, 2023 | SESE |
| [K221614](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K221614.md) | TytoCare Lung Sounds Analyzer | Tyto Care , Ltd. | Feb 24, 2023 | SESE |
| [K202062](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K202062.md) | wheezo WheezeRate Detector | Respiri Limited | Mar 11, 2021 | SESE |
| [K131285](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K131285.md) | SONOSENTRY | Isonea, Ltd. | Aug 19, 2014 | SESE |

## Top Applicants

- Tyto Care , Ltd. — 4 clearances
- Isonea, Ltd. — 1 clearance
- Respiri Limited — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ)

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