510(k) Report

FDA applicant

Advanced Medical Systems, Inc.

Hamden, CT10 decisions1988–19960 recalls

FDA records 10 decisions for Advanced Medical Systems, Inc. (Hamden, CT) from 1988 to 1996: 10 510(k) clearances. Most are in product codes HGL (Transducer, Ultrasonic, Obstetric) and HGM (System, Monitoring, Perinatal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Advanced Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Medical Systems, 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?

  • HGLTransducer, Ultrasonic, Obstetric2decisions
  • HGMSystem, Monitoring, Perinatal2decisions
  • BZGSpirometer, Diagnostic1decision
  • DQAOximeter1decision
  • HGPElectrode, Circular (Spiral), Scalp And Applicator1decision
  • KPQSystem, Simulation, Radiation Therapy1decision

Also: BTY (1), HEK (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.

  • K940898Model IM77 Intrapartum Fetal MonitorAdvanced Medical Systems, Inc. · 19951cites it
  • K932278PFM Professional 7000 SpirometerAdvanced Medical Systems, Inc. · 19931cites it

What has FDA decided for it lately?

  • K955931Model IM77 Intrapartum Fetal Monitor (Modification)Advanced Medical Systems, Inc. · 1996
  • K952031Ultrasound Transducer, Model US917Advanced Medical Systems, Inc. · 1995
  • K940898Model IM77 Intrapartum Fetal MonitorAdvanced Medical Systems, Inc. · 1995
  • K923335Ultrasound Transucer, Model US915 -- ModificationAdvanced Medical Systems, Inc. · 1994
  • K932278PFM Professional 7000 SpirometerAdvanced Medical Systems, Inc. · 1993
  • K911657Fetal Scalp Spiral ElectrodeAdvanced Medical Systems, Inc. · 1991
  • K902190Fetal Pulse Detector Model Dop-1Advanced Medical Systems, Inc. · 1990
  • K894568New Rad-8 Treatment Planning Computer SystemAdvanced Medical Systems, Inc. · 1990

All 10 as Advanced Medical Systems, Inc. →