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

Device, Fertility Diagnostic, Contraceptive, Software Application

21 CFR 884.5370 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PYT is the FDA product code for Device, Fertility Diagnostic, Contraceptive, Software Application, a class II device type, regulated under 21 CFR 884.5370. FDA's definition for this code reads: "Designed to monitor and provide fertility information to prevent pregnancy (contraception)". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PYT
Device name
Device, Fertility Diagnostic, Contraceptive, Software Application
FDA definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Regulation
21 CFR 884.5370
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code PYT

By decision year
7 clearances under product code PYT with a decision year between 2018 and 2026, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PYT by decision year
YearClearances
20181
20212
20231
20241
20251
20261

Applicants with the most clearances

Product code PYT
Applicants holding the most 510(k) clearances under product code PYT
ApplicantClearances
Natural Cycles Nordic AB6
Biowink GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code