510(k) Report

FDA applicant

Bales Scientific, Inc.

Walnut Creek, CA3 decisions1985–19980 recalls

FDA records 3 decisions for Bales Scientific, Inc. (Walnut Creek, CA) from 1985 to 1998: 3 510(k) clearances. Most are in product codes LHQ (System, Telethermographic (Adjunctive Use)) and ILY (Lamp, Infrared, Therapeutic Heating). 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 Bales Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bales Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bales Scientific, 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?

  • LHQSystem, Telethermographic (Adjunctive Use)2decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K974468Photonic StimulatorBales Scientific, Inc. · 19984cite it
  • K897191Bsi Model TipBales Scientific, Inc. · 19901cites it

What has FDA decided for it lately?

  • K974468Photonic StimulatorBales Scientific, Inc. · 1998
  • K897191Bsi Model TipBales Scientific, Inc. · 1990
  • K850534Bsi Model MCT 7000-Thermal Imaging SystemBales Scientific, Inc. · 1985

All 3 as Bales Scientific, Inc. →