Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PHZ · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
227 daysmedian FDA review time
470 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | 2026-06-02 | 267 | 0 |
| K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | 2025-04-07 | 140 | 0 |
| K240555 | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | 2024-07-02 | 125 | 0 |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | 2023-12-13 | 138 | 0 |
| K221614 | TytoCare Lung Sounds Analyzer | Tyto Care , Ltd. | 2023-02-24 | 266 | 0 |
| K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021-03-11 | 227 | 0 |
| K131285 | SONOSENTRY | Isonea, Ltd. | 2014-08-19 | 470 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda