# K250148: Medical Gas Analyzer (AG200)

- Pathway: 510(k) (Traditional)
- Applicant: Prior Care Science Technology, Ltd.
- Decided: Aug 28, 2025 after 219 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: 5 generations back to K935370 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123043: Irma C02 Model 200101; Irma AX 200601, Phasein AB (2012) Summary page 6.

## Indications for use
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases C02, N20 and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane. 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.The C02 may also be used in the emergency medical services environment and road ambulances. Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

Source page: https://510kreport.com/device/K250148
Methodology: https://510kreport.com/methodology