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510(k) K202897

Natural Cycles by Natural Cycles Nordic AB — Product Code PYT

K202897 is an FDA 510(k) premarket notification submitted by Natural Cycles Nordic AB for the device "Natural Cycles". The FDA issued a decision of Substantially Equivalent on June 24, 2021. The device falls under product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application), a Class II device regulated under 21 CFR 884.5370. Natural Cycles Nordic AB has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2021
Date Received
September 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fertility Diagnostic, Contraceptive, Software Application
Device Class
Class II
Regulation Number
884.5370
Review Panel
OB
Submission Type

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

Other clearances by Natural Cycles Nordic AB

  • K250561 — Natural Cycles (March 21, 2025)
  • K241006 — Natural Cycles (July 11, 2024)
  • K231274 — Natural Cycles (August 24, 2023)
  • DEN170052 — Natural Cycles (August 10, 2018)

Other clearances for product code PYT

  • K250561 — Natural Cycles (March 21, 2025)
  • K241006 — Natural Cycles (July 11, 2024)
  • K231274 — Natural Cycles (August 24, 2023)
  • K193330 — Clue Birth Control (February 18, 2021)
  • DEN170052 — Natural Cycles (August 10, 2018)

FDA data resources