510(k) Report

FDA applicant

American Mcgaw

Mchenry, IL13 decisions1981–19858 recalls

FDA records 13 decisions for American Mcgaw (Mchenry, IL) from 1981 to 1985: 13 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KPE (Container, I.V.). 8 recalls are 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 American Mcgaw’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Mcgaw since 2007.

Recalls per year

4in 2025

2019: 42025: 4
2007high 4 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Mcgaw 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?

  • FPASet, Administration, Intravascular3decisions
  • KPEContainer, I.V.2decisions
  • FKXSystem, Peritoneal, Automatic Delivery2decisions
  • LHISet, I.V. Fluid Transfer1decision
  • FLNMonitor, Electric For Gravity Flow Infusion Systems1decision
  • FDAEnteroscope And Accessories1decision

Also: KFX (1), KDJ (1), FRN (1).

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K840212Concentrated Platelet Admin. SetAmerican Mcgaw · 19841cites it
  • K820133Mcgaw Fat Emulsion SetAmerican Mcgaw · 19821cites it

What has FDA decided for it lately?

  • K853549Mcgaw/Drop Watch Flow MonitorAmerican Mcgaw · 1985
  • K843639Add-a-Vial Solution Transfer DeviceAmerican Mcgaw · 1985
  • K843954Mixing ContainerAmerican Mcgaw · 1984
  • K841729Accupro Enteral Feeding PumpAmerican Mcgaw · 1984
  • K840388Pab IV ContainerAmerican Mcgaw · 1984
  • K840212Concentrated Platelet Admin. SetAmerican Mcgaw · 19848 recalls
  • K831716Capd - Catheter AdapterAmerican Mcgaw · 1983
  • K822240Ethylene Oxide Steriliz. Parametric Rel.American Mcgaw · 1982

All 13 as American Mcgaw →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K083723Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K083723Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K083723Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K140311Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K083723Y-Type Blood Set, Catalog Number 490293Nov 20, 2019Class II
  • K083723Y-Type Blood Set, Catalog Number 490314Nov 20, 2019Class II