510(k) Report

FDA applicant

Nutec, Inc.

Winfield, IL3 decisions1994–19940 recalls

FDA records 3 decisions for Nutec, Inc. (Winfield, IL) in 1994: 3 510(k) clearances. Most are in product codes NHK (Resuscitator, Manual, Non Self-Inflating) and BZA (Connector, Airway (Extension)). 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 Nutec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nutec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nutec, 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?

  • NHKResuscitator, Manual, Non Self-Inflating1decision
  • BZAConnector, Airway (Extension)1decision
  • CAFNebulizer (Direct Patient Interface)1decision

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.

  • K940255Hyperinflation Bag SystemNutec, Inc. · 19941cites it

What has FDA decided for it lately?

  • K940257Hand-Held NebulizerNutec, Inc. · 1994
  • K940255Hyperinflation Bag SystemNutec, Inc. · 1994
  • K935821Double Trach Swivel ConnectorNutec, Inc. · 1994

All 3 as Nutec, Inc. →

Other applicant names beginning “Nutec”

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

Nutec Med, Inc. 1