# K162131: ExSpiron 1Xi

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Motion, Inc.
- Decided: May 9, 2017 after 281 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: 24 generations back to K941811 (1994). 150 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130170: Exspiron 1XI, Respiratory Motion, Inc. (2013) Summary page 4.

## Most influential descendants
- K173181: ExSpiron 1Xi (2018), 2 descendants of its own
- K260226: ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (2026), 0 descendants of its own
- K192595: ExSpiron 2Xi (2019), 0 descendants of its own

## Indications for use
ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients. ExSpiron 1Xi 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 1Xi measurements are used as an adjunct to other clinical information.

Source page: https://510kreport.com/device/K162131
Methodology: https://510kreport.com/methodology