Zoll M Series ETC02 LoFlo Option
510(k) K042417
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042417 | Date5 Oct 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Zoll M Series ETC02 LoFlo Option is an Automated External Defibrillator (Non-Wearable) designed for continuous noninvasive monitoring of end-tidal carbon dioxide (EtCO₂) and respiration rate. It integrates with the Zoll M Series defibrillator to provide real-time respiratory assessment during cardiac emergencies, aiding in patient evaluation and treatment decisions.
This device is supplied as a reusable component for use with the Zoll M Series defibrillator system in clinical and prehospital settings. It operates in conjunction with the defibrillator’s existing functionality, requiring no additional sterility measures beyond standard device preparation. The device is classified as Class III under FDA regulation 870.5310 and holds a Special 510(k) clearance (K042417) for cardiovascular applications, with no MRI safety restrictions specified.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
What clinical scenarios or settings is the Zoll M Series ETC02 LoFlo Option intended to enhance during cardiac emergencies?
The Zoll M Series ETC02 LoFlo Option is designed to provide continuous noninvasive monitoring of end-tidal carbon dioxide (EtCO₂) and respiration rate during cardiac emergencies. It integrates with the Zoll M Series defibrillator to offer real-time respiratory assessment, which aids clinicians in evaluating patients more comprehensively during resuscitation efforts in both clinical (e.g., hospital ERs, ICUs) and prehospital settings (e.g., ambulances, emergency response units).
Is the ETC02 LoFlo Option a single-use or reusable component, and what does that mean for maintenance?
The ETC02 LoFlo Option is supplied as a reusable component for use with the Zoll M Series defibrillator system. This means it is not disposable and can be cleaned, disinfected, and reused according to standard device preparation protocols for reusable medical equipment. Maintenance includes adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and periodic inspection to ensure proper functionality.
Does the ETC02 LoFlo Option require additional sterility measures beyond standard defibrillator preparation?
No, the device does not require additional sterility measures beyond those already applied to the Zoll M Series defibrillator system. Since it is a reusable component designed to integrate with the defibrillator, standard cleaning and disinfection protocols for reusable medical devices—such as those outlined by the manufacturer—are sufficient to maintain its safety and functionality.
How is the ETC02 LoFlo Option regulated, and what does its classification as Class III under FDA 870.5310 imply?
The Zoll M Series ETC02 LoFlo Option holds a Special 510(k) clearance (K042417) under FDA regulation 870.5310, classifying it as a Class III device for cardiovascular applications. This classification indicates it is subject to stringent premarket approval requirements due to its role in life-supporting or life-sustaining functions, ensuring rigorous evaluation of safety and effectiveness before market authorization.
Can the ETC02 LoFlo Option be used with any Zoll M Series defibrillator, or is it specific to certain models?
The ETC02 LoFlo Option is designed specifically to integrate with the Zoll M Series defibrillator system, but it is not limited to a single model. It functions as a reusable add-on component to provide EtCO₂ and respiration monitoring capabilities. For compatibility and proper operation, it must be used with an authorized Zoll M Series defibrillator model that supports this feature, as outlined in the manufacturer’s instructions.