510(k) Report

FDA applicant

County Line, Ltd.

Warrensville, OH1 decision1996–19960 recalls

FDA records 1 decision for County Line, Ltd. (Warrensville, OH) in 1996: 1 510(k) clearance. All are in product code LIX (Aid, Cardiopulmonary Resuscitation). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for County Line, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like County Line, 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?

  • LIXAid, Cardiopulmonary Resuscitation1decision

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.

  • K954692CPR PromptCounty Line, Ltd. · 19961cites it

What has FDA decided for it lately?

  • K954692CPR PromptCounty Line, Ltd. · 1996

The one decision as County Line, Ltd. →