Atlas FDA

PYT

7 FDA 510(k) clearances · Product code

238 daysmedian time to decision
444 days90th percentile
7clearances measured

FDA profile

Official device name
Device, Fertility Diagnostic, Contraceptive, Software Application
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5370
Medical specialty
Obstetrics/Gynecology
FDA definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
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RecordFirmDate
Natural Cycles (K253694)Natural Cycles Nordic AB2026-07-17
Natural Cycles (K250561)Natural Cycles Nordic AB2025-03-21
Natural Cycles (K241006)Natural Cycles Nordic AB2024-07-11
Natural Cycles (K231274)Natural Cycles Nordic AB2023-08-24
Natural Cycles (K202897)Natural Cycles Nordic AB2021-06-24
Clue Birth Control (K193330)Biowink GmbH2021-02-18
Natural Cycles (DEN170052)Natural Cycles Nordic AB2018-08-10

Track PYT automatically

Every clearance here is in the API, with alerts when new ones post.