# K091853: Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014

- Pathway: 510(k) (Traditional)
- Applicant: Nspire Health, Inc.
- Decided: Sep 21, 2009 after 90 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boehringer Laboratories Adult Spirometer #8800: named in the summary without a submission number

## Most influential descendants
- K120087: Exspiron (2012), 8 descendants of its own
- 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

## Indications for use
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery. It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.

Source page: https://510kreport.com/device/K091853
Methodology: https://510kreport.com/methodology