510(k) Report

FDA applicant

First Touch Disposables, Inc.

Wilmington, NC2 decisions1992–19970 recalls

FDA records 2 decisions for First Touch Disposables, Inc. (Wilmington, NC) from 1992 to 1997: 2 510(k) clearances. Most are in product codes FMT (Warmer, Infant Radiant) and FMZ (Incubator, Neonatal). 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 First Touch Disposables, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for First Touch Disposables, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — First Touch Disposables, 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?

  • FMTWarmer, Infant Radiant1decision
  • FMZIncubator, Neonatal1decision

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.

  • K950422First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc. · 19971cites it

What has FDA decided for it lately?

  • K950422First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc. · 1997
  • K915752First Touch/Viledon Non-Woven FilterFirst Touch Disposables, Inc. · 1992

All 2 as First Touch Disposables, Inc. →