# K984254: Infant Flow Ncpap Masks

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Feb 24, 1999 after 89 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
Longest line of descent: 1 generation back to K945740 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962848: Hans Rudolph Nasal Cpap Mask, Hans Rudolph, Inc. (1996) Summary page 1.
- K974303: Infant Flow System, Sensor Medics Corp. (1998) Summary page 1.
- K960359: Aladdin Monitoring Oxygen/Air Mixer, Hamilton Medical, Inc. (1996) Summary page 1.
- K945740: Infant Flow System, Hamilton Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- 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 NCPAP Masks are intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

Source page: https://510kreport.com/device/K984254
Methodology: https://510kreport.com/methodology