# K180788: Gas Module 3

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 24, 2018 after 212 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- 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 K974903 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062754: Gas Module SE, Model 0998-00-0481-02, Datascope Corp. (2006) Summary page 5.

## Indications for use
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

Source page: https://510kreport.com/device/K180788
Methodology: https://510kreport.com/methodology