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PYT — Device, Fertility Diagnostic, Contraceptive, Software Application Class II

FDA Device Classification

Classification Details

Product Code
PYT
Device Class
Class II
Regulation Number
884.5370
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

Designed to monitor and provide fertility information to prevent pregnancy (contraception).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250561natural cycles nordicNatural CyclesMarch 21, 2025
K241006natural cycles nordicNatural CyclesJuly 11, 2024
K231274natural cycles nordicNatural CyclesAugust 24, 2023
K202897natural cycles nordicNatural CyclesJune 24, 2021
K193330biowinkClue Birth ControlFebruary 18, 2021
DEN170052natural cycles nordicNatural CyclesAugust 10, 2018