510(k) Report

FDA applicant

Advanced Respiratory

St. Paul, MN2 decisions2001–20030 recalls

FDA records 2 decisions for Advanced Respiratory (St. Paul, MN) from 2001 to 2003: 2 510(k) clearances. All are in product code BYI (Percussor, Powered-Electric). Its devices cite 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Advanced Respiratory since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Respiratory 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?

  • BYIPercussor, Powered-Electric2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K024309The Vest Airway Clearance System, Model 104Advanced Respiratory · 20034cite it
  • K012928Abi Vest Airway Clearance SystemAdvanced Respiratory · 20012cite it

What has FDA decided for it lately?

  • K024309The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
  • K012928Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001

All 2 as Advanced Respiratory →