510(k) Report

FDA applicant

Organic Essentials

O'Donnell, TX1 decision1998–19980 recalls

FDA records 1 decision for Organic Essentials (O'Donnell, TX) in 1998: 1 510(k) clearance. All are in product code HEB (Tampon, Menstrual, Unscented). 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 Organic Essentials’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Organic Essentials since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Organic Essentials 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?

  • HEBTampon, Menstrual, Unscented1decision

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.

  • K983478Organic Essentials, Organic Cotton TamponOrganic Essentials · 19981cites it

What has FDA decided for it lately?

  • K983478Organic Essentials, Organic Cotton TamponOrganic Essentials · 1998

The one decision as Organic Essentials →