Is Pivot Breathe FDA approved or cleared?
Not as such. Pivot Health holds a 510(k) clearance for related hardware, latest decision in 2021, but Pivot Breathe itself is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Pivot Breathe |
|---|---|
| Maker | Pivot Health |
| Care area | Mental health |
| What it does | Digital therapeutic for smoking cessation with breath monitoring |
| FDA | 510(k), latest decision 2021 |
| Verification level | Related hardware authorised; this app itself is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | pivot.co |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes