510(k) Report

FDA applicant

Palco Labs, Inc.

Santa Cruz, CA2 decisions2000–20000 recalls

FDA records 2 decisions for Palco Labs, Inc. (Santa Cruz, CA) in 2000: 2 510(k) clearances. All are in product code DQA (Oximeter). 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 Palco Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Palco Labs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Palco Labs, 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?

  • DQAOximeter2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K994372MODEL 120Palco Labs, Inc. · 20002cite it

What has FDA decided for it lately?

  • K002787Model 120, Oxysoft, Infrared Data Converter, Model 120Palco Labs, Inc. · 2000
  • K994372MODEL 120Palco Labs, Inc. · 2000

All 2 as Palco Labs, Inc. →

Other applicant names beginning “Palco”

FDA records each applicant name separately; these may or may not be the same firm.

Palco Laboratories, Inc. 9