# K042417: Zoll M Series ETC02 Loflo Option

- Pathway: 510(k) (Special)
- Applicant: Zoll Medical Corp
- Decided: Oct 5, 2004 after 28 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001359 (2000). 4 ancestors in all.
238 later devices descend from it; 1 cites it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993036: Zoll M Series ETCO2 Option, Zoll Medical Corp (2000) Summary page 1.
- K030431: Modification to Dash 3000/4000 Patient Monitor, Ge Medical Systems Information Technologies (2003) Summary page 2.

## Most influential descendants
- K053174: Loflo C5 CO2 Sensor (2006), 237 descendants of its own
- K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors (2006), 222 descendants of its own
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), 221 descendants of its own
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own
- K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors (2006), 188 descendants of its own

## Indications for use
The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.

Source page: https://510kreport.com/device/K042417
Methodology: https://510kreport.com/methodology