# K103604: Isa CO2, Isa AX+, Isa or+

- Pathway: 510(k) (Traditional)
- Applicant: Phasein AB
- Decided: Apr 6, 2011 after 118 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001814 (2000). 2 ancestors in all.
91 later devices descend from it; 5 cite it directly.
3 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc, GE Healthcare (2005) Summary page 1.

## Most influential descendants
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own

## Indications for use
The ISA product family consists of three types of sidestreamn gas analyzers (ISA 002, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA 002: 002 ISA AX+: 002, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane ISA OR+: 002, 02, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA 002, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA 002 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

Source page: https://510kreport.com/device/K103604
Methodology: https://510kreport.com/methodology