510(k) Report

FDA applicant

Theyfit

Covington, GA2 decisions2013–20150 recalls

FDA records 2 decisions for Theyfit (Covington, GA) from 2013 to 2015: 2 510(k) clearances. All are in product code HIS (Condom). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Theyfit’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Theyfit by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HISCondom2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122219Theyfit Male CondomTheyfit · 20132cite it

What has FDA decided for it lately?

  • K150072TheyFit Male CondomTheyfit · 2015
  • K122219Theyfit Male CondomTheyfit · 2013

All 2 as Theyfit →