FDA 510(k) · Ava
K200163: Ava Fertility Tracker (Ava AG)
Ava AG received FDA 510(k) K200163 for Ava Fertility Tracker, with a decision date of Jan 19, 2021 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))
FDA facts
| FDA number | K200163 |
|---|---|
| Pathway | 510(k) |
| Applicant | Ava AG |
| Device name | Ava Fertility Tracker |
| Product code | LHD: Device, Fertility Diagnostic, Proceptive |
| Regulation (21 CFR) | Not listed |
| Device class | Class U |
| Date received | Jan 22, 2020 |
| Decision date | Jan 19, 2021 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LHD is "Device, Fertility Diagnostic, Proceptive", class U.
Our labels for filtering: claim Fertility / cycle, sensor Other. These are heuristics, not FDA fields.