# K051279: Caldyne, Inc. Exhalometer EX100, Model EX100

- Pathway: 510(k) (Traditional)
- Applicant: Caldyne, Inc.
- Decided: Sep 7, 2005 after 113 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: 2 generations back to K914272 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983274: Startrack Infant Graphics Monitor, Nellcor Puritan Bennett, Inc. (1998) Summary page 5.
- K973314: Spirosafe Filter, Micro Direct, Inc. (1997) Summary page 5.

## Indications for use
The EXHALOMETERTM EX100 is intended to measure the tidal volume, minute volume and respiration rate being delivered to the patient via expiratory ports of resuscitation devices such as transport ventilators and resuscitators. The device is primarily used by Emergency Medical Technicians during emergency transport operations and can also be used for intra-hospital transport. The device is used for indicating how well the resuscitator is functioning. In addition, the device is used for periodically checking the adequacy of the ventilation effort of patients who have initiated spontaneous respiration. The EXHALOMETER can also be used for training and developing resuscitation techniques.

Source page: https://510kreport.com/device/K051279
Methodology: https://510kreport.com/methodology