# K221030: Model 9100 PFT/DICO

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph Ireland, Ltd.
- Decided: Jul 15, 2022 after 99 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942211 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161534: EasyOne Pro Respiratory Analysis System, Ndd Medizintechnik AG (2017) Summary page 4.

## Most influential descendants
- K223818: Model 9160 VitaloQUB (2023), 0 descendants of its own

## Indications for use
The Model 9100 PFT/DlCO 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 and SBN2. The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians’ offices. The Model 9100 PFT/DlCO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

Source page: https://510kreport.com/device/K221030
Methodology: https://510kreport.com/methodology