# K101873: Masterscreen Ios

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Feb 10, 2011 after 219 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954140 (1995). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954140: Masterscreen Ios, Erich Jaeger GmbH & Co. KG (1995) Summary page 2.

## Most influential descendants
- K152585: Resmon PRO FULL (2016), 2 descendants of its own
- K170185: tremoFlo C-100 Airwave Oscillometry System (2017), 1 descendant of its own
- K221024: tremoflo C2 Airwave Oscillometry System (2023), 0 descendants of its own

## Indications for use
The MasterScreen lOS is intended to be used for measurement and data collection of lung function parameters in humans. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements and the IOS (multifirequent oscillometry determination) measurement. Tests can be easily and quickly conducted on the basis of Impulse Oscillomtry. The device is useful in the field of early diagnosis in every-day-routine, for clinical trend observations as well as for epidemniologic studies. As only a minimum of patient cooperation is required, Impulse Oscillometry is also suitable for pediatric and geriatric studies. Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. The MasterScreen lOS is powered from 100-240 V /50-60 Hz wall outlets. No energy is transferred to the patient.

Source page: https://510kreport.com/device/K101873
Methodology: https://510kreport.com/methodology