Cleared Traditional

K200163 - Ava Fertility Tracker (FDA 510(k) Clearance)

K200163 · Ava AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
363d
Days
-
Risk

K200163 is an FDA 510(k) clearance for the Ava Fertility Tracker. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Ava AG (Zurich, CH). The FDA issued a Cleared decision on January 19, 2021 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ava AG devices

Submission Details

510(k) Number K200163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date January 19, 2021
Days to Decision 363 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 160d · This submission: 363d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHD Device, Fertility Diagnostic, Proceptive
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT03161873 Completed Observational

Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

194
Patients (actual)
1
Site
Condition studied Fertility Disorders; Early Pregnancy
Eligibility Female only · 20 Years+ · Healthy volunteers accepted
Principal investigator Brigitte Leeners, Prof
Sponsor University of Zurich
Started 2016-11-01 → Primary completion 2020-11-01
Primary outcome
Correlation between the physiology and the menstrual cycle dynamics
Secondary outcome
Correlation between the physiology measured using a wearable device and the occurrence of pregnancy
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov