# K081823: Masterscreen Paed - Baby Body

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: May 18, 2009 after 325 days
- Product code: CCM (Plethysmograph, Pressure)
- Device class: 2
- Regulation: 21 CFR 868.1750
- 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 K853390 (1986). 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)
- K023796: MS Paed-Baby Body, Erich Jaeger GmbH (2003) Summary page 2.
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body, Viasys Healthcare GmbH (2008) Summary page 2.
- K011344: Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400, Collins Medical, Inc. (2002) Summary page 2.

## Indications for use
The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent. The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V I 50-60Hz wall outlet.

Source page: https://510kreport.com/device/K081823
Methodology: https://510kreport.com/methodology