510(k) Report

FDA applicant

Healthpoint, Ltd.

Euless, TX2 decisions2005–20100 recalls

FDA records 2 decisions for Healthpoint, Ltd. (Euless, TX) from 2005 to 2010: 2 510(k) clearances. All are in product code MED (Sterilant, Medical Devices). Its devices cite 1 predicate, 1 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 hospital panel, where it files most

How often FDA has decided Healthpoint, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Healthpoint, Ltd.’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?

  • MEDSterilant, Medical Devices2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K041360Aldahol Iii High-Level DisinfectantHealthpoint, Ltd. · 20052cite it

What has FDA decided for it lately?

  • K091890Extended Use Aldahol High Level DisinfectantHealthpoint, Ltd. · 2010
  • K041360Aldahol Iii High-Level DisinfectantHealthpoint, Ltd. · 2005

All 2 as Healthpoint, Ltd. →