510(k) Report

FDA applicant

Trans-Pacific Healthcare-USA

Naples, FL1 decision1990–19900 recalls

FDA records 1 decision for Trans-Pacific Healthcare-USA (Naples, FL) in 1990: 1 510(k) clearance. All are in product code FLN (Monitor, Electric For Gravity Flow 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 Trans-Pacific Healthcare-USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trans-Pacific Healthcare-USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trans-Pacific Healthcare-USA 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?

  • FLNMonitor, Electric For Gravity Flow Infusion Systems1decision

What has FDA decided for it lately?

  • K902808DriptrolTrans-Pacific Healthcare-USA · 1990

The one decision as Trans-Pacific Healthcare-USA →

Other applicant names beginning “Trans-Pacific”

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

Trans Vascular Incorporated 2Trans World Agency, Inc. 2Trans-National Trade Development Corp. 2Trans Texas Medical Devices Corp. 1Trans-America Enterprises Corp. 1Trans-Med Corp. 1Trans American Chemical Corp. 1Trans Aire 1Trans Ancient Products Co., Ltd. 1Trans-Atlantic Dental 1Trans Pace, Inc. 1