510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250561Substantially Equivalent

Natural Cycles

Natural Cycles Nordic AB, Stockholm, SE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250561 is the FDA 510(k) clearance record for Natural Cycles, a class II device, cleared for Natural Cycles Nordic AB on under FDA product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application). FDA's definition for product code PYT reads: "Designed to monitor and provide fertility information to prevent pregnancy (contraception)". FDA records list 6 510(k) clearances for Natural Cycles Nordic AB, from to . As of , FDA records show no recalls naming K250561.

Clearance record

Decision date
Received
(24 days to decision)
Product code
PYT Device, Fertility Diagnostic, Contraceptive, Software Application
Regulation
21 CFR 884.5370
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Natural Cycles Nordic AB Sankt Eriksgatan 63 B, Stockholm, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PYT

Trailing 12 months
1 clearance under product code PYT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PYT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260