510(k) Report

FDA applicant

Pacific Device, Inc.

San Diego, CA5 decisions1990–19970 recalls

FDA records 5 decisions for Pacific Device, Inc. (San Diego, CA) from 1990 to 1997: 5 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and BSY (Catheters, Suction, Tracheobronchial). 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 Pacific Device, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacific Device, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pacific Device, 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?

  • LHISet, I.V. Fluid Transfer2decisions
  • BSYCatheters, Suction, Tracheobronchial1decision
  • FPASet, Administration, Intravascular1decision
  • KPEContainer, I.V.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.

  • K972464Vitalmix Plus Empty I.V. ContainerPacific Device, Inc. · 19971cites it

What has FDA decided for it lately?

  • K972464Vitalmix Plus Empty I.V. ContainerPacific Device, Inc. · 1997
  • K923782Transfer SetPacific Device, Inc. · 1993
  • K912860Intravascular Administration SetsPacific Device, Inc. · 1991
  • K912596Meconium AspirationPacific Device, Inc. · 1991
  • K902482Vitalmix (Set & Bag)Pacific Device, Inc. · 1990

All 5 as Pacific Device, Inc. →