510(k) Report

FDA applicant

Eusa Pharma (Uk) Limited

Hemel Hempstead, GB2 decisions2017–20241 recall

FDA records 2 decisions for Eusa Pharma (Uk) Limited (Hemel Hempstead, GB) from 2017 to 2024: 2 510(k) clearances. All are in product code LFD (Saliva, Artificial). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Eusa Pharma (Uk) Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2017high 1 (2025) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Eusa Pharma (Uk) Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFDSaliva, Artificial2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited · 20241 recall
  • K162167Caphosol Artifical Saliva TabletsEusa Pharma (Uk) Limited · 2017

All 2 as Eusa Pharma (Uk) Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • K234015Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution…Jun 11, 2025Class II