Tyto Care , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tyto Care , Ltd.” (first 2016, latest 2026), plus 1 De Novo decision, across 4 product codes in 4 review panels. Median 510(k) review time under this name: 181 days. Since 2017 the median was 160 days, against 194 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 250 |
| 2017 | 0 | — |
| 2018 | 1 | 181 |
| 2019 | 1 | 49 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 202 |
| 2024 | 1 | 125 |
| 2025 | 1 | 140 |
| 2026 | 2 | 260 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tyto Care , Ltd. took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 194 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHZ | Abnormal Breath Sound Device | 5 | 5 |
| DQD | Stethoscope, Electronic | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| SHL | Ear, Nose, And Throat Image Analyzer | 1 | 0 |
Review panels
- Anesthesiology (5)
- Cardiovascular (3)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Tyto Care , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | PHZ | 2026-06-02 | 267 |
| K252089 | Tyto Stethoscope (G3) | DQD | 2026-03-12 | 253 |
| K243567 | Tyto Insights for Rhonchi Detection | PHZ | 2025-04-07 | 140 |
| K240555 | Tyto Insights for Crackles Detection | PHZ | 2024-07-02 | 125 |
| K232237 | Tyto Insights for Wheeze Detection | PHZ | 2023-12-13 | 138 |
| K221614 | TytoCare Lung Sounds Analyzer | PHZ | 2023-02-24 | 266 |
| K190242 | Tyto Thermometer | FLL | 2019-03-27 | 49 |
| K181612 | Tyto Stethoscope (OTC) | DQD | 2018-12-17 | 181 |
| K160401 | Tyto Stethoscope | DQD | 2016-10-19 | 250 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250014 | De Novo | Ear, Nose, And Throat Image Analyzer | 2026-03-17 |
Recalls
openFDA lists no recalls under a recalling firm named Tyto Care , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tyto Care , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Tyto Care , Ltd.” (first 2016, latest 2026), plus 1 De Novo decision, across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tyto Care , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tyto Care , Ltd. is 181 days. Since 2017: 160 days, versus 194 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tyto Care , Ltd.?
The most frequent FDA product codes under this applicant name are PHZ (Abnormal Breath Sound Device, 5); DQD (Stethoscope, Electronic, 3); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 9 Tyto Care , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PHZ, Tyto Care , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.