510(k) Report

FDA applicant

Chest M.I., Inc.

Austin, TX2 decisions2009–20090 recalls

FDA records 2 decisions for Chest M.I., Inc. (Austin, TX) in 2009: 2 510(k) clearances. All are in product code BZG (Spirometer, Diagnostic). Its devices cite 4 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 Chest M.I., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Chest M.I., Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZGSpirometer, Diagnostic2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 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.

  • K090646Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 20091cites it

What has FDA decided for it lately?

  • K090646Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 2009
  • K080921Spiro-Master PC-10 Spirometry SystemChest M.I., Inc. · 2009

All 2 as Chest M.I., Inc. →

Other applicant names beginning “Chest”

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

Chest Innovations, Inc. 1Chest Wall Innovations, Inc. 1