510(k) Report

FDA applicant

Kendall-Ltp

Chicopee, MA1 decision1996–19960 recalls

FDA records 1 decision for Kendall-Ltp (Chicopee, MA) in 1996: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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 Kendall-Ltp’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kendall-Ltp since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DRXElectrode, Electrocardiograph1decision

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.

  • K953649Disposable Ecg ElectrodeKendall-Ltp · 19962cite it

What has FDA decided for it lately?

  • K953649Disposable Ecg ElectrodeKendall-Ltp · 1996

The one decision as Kendall-Ltp →

Other applicant names beginning “Kendall-Ltp”

FDA records each applicant name separately; these may or may not be the same firm.

Kendall Healthcare Products Co. Div.Of Tyco Health 66Kendall 22Kendall Research Center 14Kendall Mcgaw Laboratories, Inc. 13The Kendall Company Div. of Tyco Healthcare Group 4