510(k) Report

FDA applicant

Pan-America Hyperbarics, Inc.

San Antonio, TX4 decisions2002–20130 recalls

FDA records 4 decisions for Pan-America Hyperbarics, Inc. (San Antonio, TX) from 2002 to 2013: 4 510(k) clearances. Most are in product codes CBF (Chamber, Hyperbaric) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 13 predicates, 0 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, anesthesiology panel, where it files most

How often FDA has decided Pan-America Hyperbarics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pan-America Hyperbarics, 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?

  • CBFChamber, Hyperbaric3decisions
  • CBKVentilator, Continuous, Facility Use1decision

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 20022cite it

What has FDA decided for it lately?

  • K122560Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1Pan-America Hyperbarics, Inc. · 2013
  • K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
  • K021690Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1Pan-America Hyperbarics, Inc. · 2002
  • K021689Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2Pan-America Hyperbarics, Inc. · 2002

All 4 as Pan-America Hyperbarics, Inc. →