# K223818: Model 9160 VitaloQUB

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph Ireland, Ltd.
- Decided: May 25, 2023 after 155 days
- Product code: JEH (Plethysmograph, Volume)
- Device class: 2
- Regulation: 21 CFR 868.1760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942211 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022636: Body Box 5500, Morgan Scientific, Inc. (2003) Summary page 4.
- K221030: Model 9100 PFT/DICO, Vitalograph Ireland, Ltd. (2022) Summary page 4.

## Indications for use
The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers. The Model 9160 VitaloQUB is a pulmonary function testing device which uses Morgan Scientific’s ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2, SBN2, Thoracic Gas Volume (TGV) and Airway Resistance (Raw)

Source page: https://510kreport.com/device/K223818
Methodology: https://510kreport.com/methodology