FDA product code PHZ: Abnormal Breath Sound Device
PHZ is the FDA product code for abnormal breath sound device. It is a Class II device, regulated under 21 CFR 868.1900 and reviewed by the Anesthesiology panel. FDA has cleared 7 510(k) submissions under PHZ, 5 in the last five years, from 3 different applicants. The average 510(k) review took 233 days (median 227); 177 days on average over the last three years.
Definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Classification
| Field | Value |
|---|---|
| Device name | Abnormal Breath Sound Device |
| Device class | Class II |
| Regulation | 21 CFR 868.1900 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PHZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 227 |
| 2023 | 2 | 202 |
| 2024 | 1 | 125 |
| 2025 | 1 | 140 |
| 2026 | 1 | 267 |
Compare with all 510(k) review times · Search every PHZ clearance
Top PHZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tyto Care , Ltd. | 5 | 2026-06-02 |
| Respiri Limited | 1 | 2021-03-11 |
| Isonea, Ltd. | 1 | 2014-08-19 |
Most recent PHZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252844 | Tyto Care , Ltd. | Tyto Insights for Wheeze Detection (with PCCP) | 2026-06-02 | 267 |
| K243567 | Tyto Care , Ltd. | Tyto Insights for Rhonchi Detection | 2025-04-07 | 140 |
| K240555 | Tyto Care , Ltd. | Tyto Insights for Crackles Detection | 2024-07-02 | 125 |
| K232237 | Tyto Care , Ltd. | Tyto Insights for Wheeze Detection | 2023-12-13 | 138 |
| K221614 | Tyto Care , Ltd. | TytoCare Lung Sounds Analyzer | 2023-02-24 | 266 |
Recalls for PHZ devices
openFDA lists no recalls for product code PHZ.
Frequently asked questions
What is FDA product code PHZ?
PHZ is the FDA product code for abnormal breath sound device. It is a Class II device, regulated under 21 CFR 868.1900 and reviewed by the Anesthesiology panel.
What device class is PHZ?
Class II, regulation 21 CFR 868.1900. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHZ?
Across 7 cleared submissions the average was 233 days from receipt to decision (median 227).
Which companies have the most PHZ clearances?
Tyto Care , Ltd. (5); Respiri Limited (1); Isonea, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHZ
- Run a recall and safety report across every PHZ manufacturer
- Watch product code PHZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times