DeviceClearance

Product code PYT— Obstetrics/Gynecology

Natural Cycles

Classification name
Device, Fertility Diagnostic, Contraceptive, Software Application
Device class
Class 2
Regulation
21 CFR 884.5370
Advisory panel
Obstetrics/Gynecology
Total cleared
7
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PYT under 21 CFR 884.5370, via openFDA

Market context for product code PYT

FDA has cleared 7 devices under product code PYT between 2018 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PYT

Recent clearances under product code PYT

Data sourced from openFDA. This site is unofficial and independent of the FDA.