# K023796: MS Paed-Baby Body

- Pathway: 510(k) (Special)
- Applicant: Erich Jaeger GmbH
- Decided: Mar 3, 2003 after 110 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: 1 generation back to K853390 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853390: Infant Body Test, Erich Jaeger, Inc. (1986) Summary page 1.

## Most influential descendants
- K081823: Masterscreen Paed - Baby Body (2009), 0 descendants of its own

## Indications for use
The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants. The MS PAED - BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.

Source page: https://510kreport.com/device/K023796
Methodology: https://510kreport.com/methodology