Zoll E Series 12SL Analysis Option

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

510(k) Number

K080232 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Propaq MD

  Class III

  FDA 510(k) K112761 Active Cleared 25 Apr 2012

• Zoll Propaq Md

  Class II

  FDA 510(k) K102468 Active Cleared 30 Sep 2010

• Zoll E Series with CPRReadyCharge

  Class III

  FDA 510(k) K091265 Active Cleared 23 Dec 2009

• Zoll E Series Defibrillator

  Class III

  FDA 510(k) K072923 Active Cleared 24 Apr 2008

• Zoll E Series with Bluetooth Dial Up Networking

  Class III

  FDA 510(k) K081081 Active Cleared 9 Mar 2009

• Zoll R Series with 2010 Aha Guidelines Software Update

  Class III

  FDA 510(k) K110361 Active Cleared 8 Mar 2011

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• What types of cardiac analysis does the Zoll E Series 12SL Analysis Option perform, and how does it differ from standard defibrillators?

  The Zoll E Series 12SL Analysis Option provides automated 12-lead ECG analysis using the GE/Marquette 12SL algorithm, which interprets signals for acute myocardial infarction (AMI) diagnosis and arrhythmia documentation. Unlike standard automated external defibrillators (AEDs), which typically offer limited ECG monitoring (e.g., single-lead rhythms), this device integrates multiple monitoring parameters—including ECG, pacing, SpO₂, EtCO₂, and non-invasive blood pressure (NIBP)—for comprehensive cardiac assessment in pre-hospital, emergency, and clinical settings.

• Is the Zoll E Series 12SL Analysis Option designed for single-use or reusable applications, and what maintenance is required?

  The device is reusable and requires proper maintenance and calibration as outlined by the manufacturer. Since it is not labeled as sterile or disposable, it must be cleaned, inspected, and serviced according to Zoll’s guidelines to ensure reliable defibrillation and monitoring functionality over repeated uses.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Zoll E Series 12SL Analysis Option received FDA 510(k) clearance (K080232) under the Special 510(k) Review pathway, classified as Class III under regulation 870.5310 for automated external defibrillators (non-wearable). It was deemed substantially equivalent to a predicate device, with review by the Cardiovascular (CV) Advisory Committee.

• Can this device be used in environments where MRI scans are performed, or are there specific safety considerations?

  The provided data does not specify MRI safety information for the Zoll E Series 12SL Analysis Option. As a reusable defibrillator with electronic components, it should not be exposed to MRI environments unless explicitly tested and labeled as MRI-safe by the manufacturer. Always verify compatibility with facility MRI protocols before use.