510(k) Report

FDA applicant

A-M Systems, Inc.

Bonita Springs, FL3 decisions2000–20132 recalls

FDA records 3 decisions for A-M Systems, Inc. (Bonita Springs, FL) from 2000 to 2013: 3 510(k) clearances. All are in product code CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “A-M Systems”.

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 A-M Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — A-M Systems, 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?

  • CAHFilter, Bacterial, Breathing-Circuit3decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K000654VBMAXA-M Systems, Inc. · 20001cites it

What has FDA decided for it lately?

  • K130664Hyrdromax HmefA-M Systems · 2013
  • K063526A-M Systems Viromax Viral and Bacterial FilterA-M Systems, Inc. · 20072 recalls
  • K000654VBMAXA-M Systems, Inc. · 2000

All 2 as A-M Systems, Inc. →The one decision as A-M Systems →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K063526Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit"…Apr 16, 2010
  • K063526ViroMax viral/bacterial filter. The filter reduces the risk of infection due to…Mar 31, 2010