# K011865: Zoll M Series Ibp Operation; Zoll M Series Temperature Option

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Jul 31, 2001 after 47 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061707: Heartstart MRX, Invasive Pressure & Temperature Options (2006), 4 descendants of its own
- K130153: Hearstart MRX with Airway Confimration Assist (2013), 2 descendants of its own
- K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring (2015), 1 descendant of its own
- K200849: Tempus LS - Manual (2020), 0 descendants of its own
- K063375: Heartstart MRX, Models M3535A or M3536A (2007), 0 descendants of its own

## Indications for use
IBP The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for resting patients in critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only. Contraindications: The ZOLL M Series IBP option is not indicated for use on neonatal patients. TEMPERATURE The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors. Contraindications: The ZOLL M Series Temperature option is not indicated for use on neonatal patients.

Source page: https://510kreport.com/device/K011865
Methodology: https://510kreport.com/methodology