510(k) Report

FDA applicant

Femcap Incorporated

Mission Viejo, CA2 decisions2003–20120 recalls

FDA records 2 decisions for Femcap Incorporated (Mission Viejo, CA) from 2003 to 2012: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HHE (Cup, Menstrual) and LLQ (Cap, Cervical, Contraceptive). 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 Femcap Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Femcap Incorporated 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, Menstrual1decision
  • LLQCap, Cervical, Contraceptive1decision

What has FDA decided for it lately?

  • K121857FemmycycleFemcap Incorporated · 2012
  • P020041Femcap Barrier ContraceptiveFemcap Incorporated · 2003

All 2 as Femcap Incorporated →