510(k) Report

FDA applicant

Stewart-Naumann Laboratories

Mchenry, IL3 decisions1976–19770 recalls

FDA records 3 decisions for Stewart-Naumann Laboratories (Mchenry, IL) from 1976 to 1977: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FRN (Pump, Infusion). 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, general hospital panel, where it files most

How often FDA has decided Stewart-Naumann Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stewart-Naumann Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stewart-Naumann Laboratories 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?

  • FMFSyringe, Piston2decisions
  • FRNPump, Infusion1decision

What has FDA decided for it lately?

  • K771300Intravenous Infusion PumpStewart-Naumann Laboratories · 1977
  • K760005Syringe, Disposable, Glass & PlasticStewart-Naumann Laboratories · 1976
  • K760004Syringe, Disposable, All PlasticStewart-Naumann Laboratories · 1976

All 3 as Stewart-Naumann Laboratories →

Other applicant names beginning “Stewart-Naumann”

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

Stewart Research, Inc. 1Stewart-Riess Labs 1Stewart J. Lustgarten 1