510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193330Substantially Equivalent

Clue Birth Control

Biowink GmbH, Berlin, DE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193330 is the FDA 510(k) clearance record for Clue Birth Control, a class II device, cleared for Biowink GmbH 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 one 510(k) clearance for Biowink GmbH. As of , FDA records show no recalls naming K193330.

Clearance record

Decision date
Received
(444 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
Biowink GmbH Adalbertstrasse 7-8, Berlin, DE
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