# K130170: Exspiron 1XI

- Pathway: 510(k) (Special)
- Applicant: Respiratory Motion, Inc.
- Decided: May 29, 2013 after 125 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: 23 generations back to K941811 (1994). 149 ancestors in all.
4 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)
- K120087: Exspiron, Respiratory Motion, Inc. (2012) Summary page 1.

## Most influential descendants
- K162131: ExSpiron 1Xi (2017), 3 descendants of its own
- 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 lxi 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 of age) patients. ExSpiron lxi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of: * Tidal volume, * Respiratory rate, and * Minute ventilation. ExSpiron lxi measurements are used as an adjunct to other clinical information sources.

Source page: https://510kreport.com/device/K130170
Methodology: https://510kreport.com/methodology