Infant Electrode Belt

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830362 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sentry Radiotranslucent ECG Electrodes

  Class II

  FDA 510(k) K962122 Active Cleared 24 Jul 1996

• Duraderm Butterfly

  Class II

  FDA 510(k) K881343 Active Cleared 4 May 1988

• Sentry Flexible Tens

  Class II

  FDA 510(k) K853552 Active Cleared 26 Sep 1985

• Sentry Insertion Tray

  Class II

  FDA 510(k) K942827 Active Cleared 2 Nov 1994

• Diagnostic ECG Disposable Electrode

  Class II

  FDA 510(k) K851522 Active Cleared 24 Oct 1985

• Baby Board

  Class I

  FDA 510(k) K935098 Active Cleared 15 Feb 1994

See all devices from Sentry Medical Products, Inc. →

• What is the infant electrode belt used for?

  The infant electrode belt is used to secure electrodes to an infant during cardiovascular monitoring procedures, holding them in place to ensure reliable signal acquisition while minimizing movement artifacts in clinical settings.

• Is the infant electrode belt sterile or non-sterile, and is it reusable?

  The device is supplied non-sterile and is intended for single use only; it should not be cleaned, resterilized, or reused due to potential degradation of material integrity and risk of cross-contamination after initial application.

• What regulatory pathway was used for the infant electrode belt, and what is its product code?

  The infant electrode belt received FDA 510(k) clearance under product code DRX, with a traditional clearance type and review by the cardiovascular advisory committee, indicating it was found substantially equivalent to a legally marketed predicate device.