Zoll E Series with Intibation Assist Option

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

510(k) Number

K080903 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Zoll Medical Corporation →

• Is the Zoll E Series With Intubation Assist Option a single-use or reusable device, and what maintenance is required?

  The Zoll E Series With Intubation Assist Option is a reusable medical device. Since it is not sterile by design, it must be cleaned, calibrated, and maintained according to the manufacturer’s guidelines to ensure proper functionality and safety. Regular upkeep is essential for accurate defibrillation, ECG monitoring, and the Intubation Assist Option’s features, including EtCO₂ and impedance analysis for endotracheal tube confirmation.

• What vital signs and monitoring capabilities does this device provide beyond basic defibrillation?

  Beyond defibrillation, the Zoll E Series With Intubation Assist Option offers continuous ECG monitoring, pulse oximetry (SpO₂), end-tidal carbon dioxide (EtCO₂) measurement, and non-invasive blood pressure (NIBP) tracking. The Intubation Assist Option specifically uses EtCO₂ and transthoracic impedance to help confirm proper endotracheal tube placement by analyzing breath patterns post-intubation.

• How is this device regulated, and what classification does it hold under FDA guidelines?

  The Zoll E Series With Intubation Assist Option is classified as a Class III medical device under the FDA and holds 510(k) clearance with a special classification (decision code: SESE). It is governed by 21 CFR 870.5310, reflecting its critical role in emergency cardiovascular care. The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and is intended for use in pre-hospital and in-hospital emergency settings by trained personnel.

• Does this device require any special storage conditions, and is it compatible with MRI environments?

  The provided data does not specify any special storage conditions for the Zoll E Series With Intubation Assist Option, though standard environmental controls (e.g., temperature, humidity) should be followed to preserve functionality. There is no mention of MRI safety in the available documentation, so its compatibility with MRI environments cannot be confirmed—users should consult the manufacturer’s guidelines or safety data sheets for MRI-related risks before use in such settings.

• What distinguishes the Intubation Assist Option from standard defibrillators in this series?

  The Intubation Assist Option enhances airway management by analyzing end-tidal CO₂ (EtCO₂) and transthoracic impedance to confirm endotracheal tube placement. Unlike standard defibrillators, which focus solely on defibrillation and basic monitoring, this feature provides real-time breath-counting verification post-intubation, reducing the risk of misplaced tubes—a critical advantage in emergency scenarios where airway confirmation is time-sensitive.