510(k) Report

FDA applicant

H & S Technical Services

Mesa, AZ1 decision2004–20041 recall

FDA records 1 decision for H & S Technical Services (Mesa, AZ) in 2004: 1 510(k) clearance. All are in product code FKH (Solution-Test Standard-Conductivity, Dialysis). Its devices cite 1 predicate, 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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided H & S Technical Services’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for H & S Technical Services since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — H & S Technical Services by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like H & S Technical Services’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?

  • FKHSolution-Test Standard-Conductivity, Dialysis1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K041636H&S-Conductivity Standard SolutionH & S Technical Services · 20041 recall

The one decision as H & S Technical Services →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041636Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040…Dec 12, 2025Class II