510(k) Report

FDA applicant

Ultrafem, Inc.

Washington, DC2 decisions1993–19970 recalls

FDA records 2 decisions for Ultrafem, Inc. (Washington, DC) from 1993 to 1997: 2 510(k) clearances. All are in product code HHE (Cup, Menstrual). 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 Ultrafem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ultrafem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ultrafem, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HHECup, Menstrual2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K971303Instead, SoftcupUltrafem, Inc. · 19971cites it

What has FDA decided for it lately?

  • K971303Instead, SoftcupUltrafem, Inc. · 1997
  • K920792Softcup (TM):2Ultrafem, Inc. · 1993

All 2 as Ultrafem, Inc. →