# K974303: Infant Flow System

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Jan 30, 1998 after 74 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K984254: Infant Flow Ncpap Masks (1999), 2 descendants of its own
- K030563: Arabella Ncpap Masks (2003), 0 descendants of its own
- K012034: Modification to: Sipap Infant Nasal Cpap Circuit (2001), 0 descendants of its own

## Indications for use
The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

Source page: https://510kreport.com/device/K974303
Methodology: https://510kreport.com/methodology