510(k) Report

FDA applicant

Avacore Technologies, Inc.

Palo Alto, CA2 decisions2002–20030 recalls

FDA records 2 decisions for Avacore Technologies, Inc. (Palo Alto, CA) from 2002 to 2003: 2 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Avacore Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avacore Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Avacore Technologies, 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?

  • DWJSystem, Thermal Regulating2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K014210Palmo Thermoregulation Interface AccessoryAvacore Technologies, Inc. · 20021cites it

What has FDA decided for it lately?

  • K023934Rapid Thermal Exchange SystemAvacore Technologies, Inc. · 2003
  • K014210Palmo Thermoregulation Interface AccessoryAvacore Technologies, Inc. · 2002

All 2 as Avacore Technologies, Inc. →