# K123043: Irma C02 Model 200101; Irma AX 200601

- Pathway: 510(k) (Special)
- Applicant: Phasein AB
- Decided: Oct 25, 2012 after 27 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: 4 generations back to K935370 (1994). 9 ancestors in all.
11 later devices descend from it; 3 cite it directly.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103604: Isa CO2, Isa AX+, Isa or+, Phasein AB (2011) Summary page 1.
- K081601: Veo Multigas Monitor for Pocket PC, Phasein AB (2008) Summary page 1.

## Most influential descendants
- K123144: VIVO 50 (2013), 8 descendants of its own
- K160481: Vivo 60 (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own

## Indications for use
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases C02, N20 and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desfiurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA C02 may also be used in the emergency medical services environment and road ambulances. Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.

Source page: https://510kreport.com/device/K123043
Methodology: https://510kreport.com/methodology