# K192595: ExSpiron 2Xi

- Pathway: 510(k) (Special)
- Applicant: Respiratory Motion
- Decided: Dec 17, 2019 after 88 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: 26 generations back to K941811 (1994). 152 ancestors in all.
No later device cites it as a predicate yet.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173181: ExSpiron 1Xi, Respiratory Motion, Inc. (2018) Summary page 5.

## Indications for use
ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age. ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: - Minute Ventilation (MV) - Tidal volume (TV) - Respiratory Rate (RR) ExSpiron 2Xi measurements are used as an adjunct to other clinical information.

Source page: https://510kreport.com/device/K192595
Methodology: https://510kreport.com/methodology