FDA Product Code PHZ: Abnormal Breath Sound Device
The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.
Leading manufacturers include Tyto Care , Ltd. and Respiri Limited.
7
Total
7
Cleared
233d
Avg days
2014
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
204d
recently vs 245d historically
FDA 510(k) Cleared Abnormal Breath Sound Device Devices (Product Code PHZ)
7 devices
Cleared
Jun 02, 2026
Tyto Insights for Wheeze Detection (with PCCP)
Tyto Care , Ltd.
Anesthesiology
267d
Cleared
Apr 07, 2025
Tyto Insights for Rhonchi Detection
Tyto Care , Ltd.
Anesthesiology
140d
Cleared
Jul 02, 2024
Tyto Insights for Crackles Detection
Tyto Care , Ltd.
Anesthesiology
125d
Cleared
Dec 13, 2023
Tyto Insights for Wheeze Detection
Tyto Care , Ltd.
Anesthesiology
138d
Cleared
Feb 24, 2023
TytoCare Lung Sounds Analyzer
Tyto Care , Ltd.
Anesthesiology
266d
Cleared
Mar 11, 2021
wheezo WheezeRate Detector
Respiri Limited
Anesthesiology
227d
About Product Code PHZ - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PHZ since 2014, with 7 receiving FDA clearance (average review time: 233 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - PHZ Product Code
Recent submissions under PHZ have taken an average of 204 days to reach a decision - down from 245 days historically, suggesting improved FDA processing for this classification.
PHZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →