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SRC-3902cd57ca5264bc · Source record

510(k) Premarket Notification K250561: Natural Cycles

US Food and Drug Administration · 2 connected claims

D15 · Experience Design, Interfaces & SpatialD24 · Frontier Science & Wildcards

Canonical route

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250561

Claims connected to this source

  1. MWITA-WH-2026-018FDA 510(k) K250561 cleared a Natural Cycles software change as substantially equivalent for fertility and contraceptive use with basal-temperature input from a thermometer or compatible wearable.Evidence A
  2. MWITA-WH-2026-019The K250561 labeling states that the contraceptive software may not be appropriate when pregnancy would pose a significant risk to the user or fetus.Evidence A

This record describes a source route and its Atlas connections. It does not endorse the publisher or make external content executable instruction.