510(k) Report

FDA applicant

Arcos, Inc.

Houston, TX1 decision2013–20131 recall

FDA records 1 decision for Arcos, Inc. (Houston, TX) in 2013: 1 510(k) clearance. All are in product code PDT (Burn Resuscitation Decision Support Software). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2013high 1 (2015) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Arcos, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PDTBurn Resuscitation Decision Support Software1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131cites it

What has FDA decided for it lately?

  • K121659Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 20131 recall

The one decision as Arcos, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K121659Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125…Mar 16, 2015Class II