510(k) Report

FDA applicant

Baal Assoc., Inc.

Salt Lake City, UT1 decision1994–19940 recalls

FDA records 1 decision for Baal Assoc., Inc. (Salt Lake City, UT) in 1994: 1 510(k) clearance. All are in product code HHT (Spatula, Cervical, Cytological). 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 Baal Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baal Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Baal Assoc., 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?

  • HHTSpatula, Cervical, Cytological1decision

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.

  • K915844Exact-TouchBaal Assoc., Inc. · 19941cites it

What has FDA decided for it lately?

  • K915844Exact-TouchBaal Assoc., Inc. · 1994

The one decision as Baal Assoc., Inc. →