510(k) Report

FDA applicant

Elcare Innovations, Inc.

Burleson, TX1 decision2001–20010 recalls

FDA records 1 decision for Elcare Innovations, Inc. (Burleson, TX) in 2001: 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 Elcare Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elcare Innovations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Elcare Innovations, Inc.’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 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.

  • K010526Modification to the GripElcare Innovations, Inc. · 20012cite it

What has FDA decided for it lately?

  • K010526Modification to the GripElcare Innovations, Inc. · 2001

The one decision as Elcare Innovations, Inc. →