510(k) Report

FDA applicant

F.L.W. Plastics, Inc.

Columbus, IN4 decisions1989–19900 recalls

FDA records 4 decisions for F.L.W. Plastics, Inc. (Columbus, IN) from 1989 to 1990: 4 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and BTM (Ventilator, Emergency, Manual (Resuscitator)). 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 F.L.W. Plastics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for F.L.W. Plastics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — F.L.W. Plastics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like F.L.W. Plastics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • BTMVentilator, Emergency, Manual (Resuscitator)1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1decision

What has FDA decided for it lately?

  • K900291Mass Spectrometry Monitoring Lines and ConnectorsF.L.W. Plastics, Inc. · 1990
  • K895233Bacterial and Viral FilterF.L.W. Plastics, Inc. · 1989
  • K895357Anethesia Breathing CircuitF.L.W. Plastics, Inc. · 1989
  • K895169Manual Disposable Pulmonary ResuscitatorF.L.W. Plastics, Inc. · 1989

All 4 as F.L.W. Plastics, Inc. →