510(k) Report

FDA applicant

American I.V. Products, Inc.

Hanover, MD7 decisions2003–20120 recalls

FDA records 7 decisions for American I.V. Products, Inc. (Hanover, MD) from 2003 to 2012: 7 510(k) clearances. Most are in product codes HFM (Monitor, Uterine Contraction, External (For…) and HGM (System, Monitoring, Perinatal). Its devices cite 29 predicates, 0 of them its own earlier devices. 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 American I.V. Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 22012: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American I.V. Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like American I.V. Products, 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?

  • HFMMonitor, Uterine Contraction, External (For Use In Clinic)1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • FRNPump, Infusion1decision
  • DQAOximeter1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • FLLContinuous Measurement Thermometer1decision

Also: MRZ (1).

Whose devices does it build on?

Its devices cite 29 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.

  • K120209Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 20121cites it

What has FDA decided for it lately?

  • K120209Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012
  • K070232Ecg Cables, Trunk and Patient Lead WiresAmerican I.V. Products, Inc. · 2007
  • K070342Clinical Electronic Thermometer, Models TP11403 Through TP11413American I.V. Products, Inc. · 2007
  • K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006
  • K040392Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc. · 2004
  • K040819Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834American I.V. Products, Inc. · 2004
  • K032789Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469American I.V. Products, Inc. · 2003

All 7 as American I.V. Products, Inc. →