# K120087: Exspiron

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Motion, Inc.
- Decided: Sep 26, 2012 after 259 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: 22 generations back to K941811 (1994). 148 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091853: Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014, Nspire Health, Inc. (2009) Summary page 1.
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen GmbH (2006) Summary page 1.

## Most influential descendants
- K130170: Exspiron 1XI (2013), 4 descendants of its own
- K162131: ExSpiron 1Xi (2017), 3 descendants of its own
- K190734: Linshom Respiratory Monitoring Device (LRMD) (2020), 2 descendants of its own
- K173181: ExSpiron 1Xi (2018), 2 descendants of its own
- K240271: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (2024), 1 descendant of its own

## Indications for use
ExSpiron 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 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 measurements are used as an adjunct to other clinical information sources.

Source page: https://510kreport.com/device/K120087
Methodology: https://510kreport.com/methodology