510(k) Report

FDA applicant

American Threshold Healthcare

Enka, NC2 decisions1996–19960 recalls

FDA records 2 decisions for American Threshold Healthcare (Enka, NC) in 1996: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). Its devices cite 4 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 and plastic surgery panel, where it files most

How often FDA has decided American Threshold Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Threshold Healthcare since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Threshold Healthcare’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FXXMask, Surgical2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K955556Fluid Resistant MaskAmerican Threshold Healthcare · 19962cite it

What has FDA decided for it lately?

  • K955557Fluid Reisistant Eyeshield MaskAmerican Threshold Healthcare · 1996
  • K955556Fluid Resistant MaskAmerican Threshold Healthcare · 1996

All 2 as American Threshold Healthcare →