# K983274: Startrack Infant Graphics Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Dec 9, 1998 after 83 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- 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 K890724 (1989). 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)
- K890724: Mofification Bear NVM-1 Neonatal Volume Monitor, Bear Medical Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K051279: Caldyne, Inc. Exhalometer EX100, Model EX100 (2005), 0 descendants of its own

## Indications for use
The StarTrack Infant Graphics Monitor’s intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube <5.0mm I.D. and/or who do not exceed a peak breathing flow of 30 L/Min directly through the ET tube. The intended environments of use comprise Hospital, Hospital-type and Intra-Hospital Transport environments. The device is for prescription use only. Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities such as Surgicenters, Sub-acute Centers and Special Nursing Facilities, outside of the hospital. Intra-hospital transport includes transport with a patient within the hospital or hospital-type facility.

Source page: https://510kreport.com/device/K983274
Methodology: https://510kreport.com/methodology