# K031745: Infant Flow Plus Infant Cpap System with Sipap Function

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Feb 13, 2004 after 253 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 K833982 (1984). 5 ancestors in all.
22 later devices descend from it; 1 cites it directly.
9 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840865: Infant Star Ventilator, Infrasonics Corp. (1984) Summary page 2.
- K884521: Star Sync, Infrasonics Corp. (1989) Summary page 2.
- K011516: Infant Flow System, Model M672P, Eme (Electro Medical Equipment), Ltd. (2001) Summary page 2.
- K833982: Model IV 100B-DA Infant Ventilator, Sechrist Industries, Inc. (1984) Summary page 2.
- K991972: Infant Flow System, Sensor Medics Corp. (1999) Summary page 2.

## Most influential descendants
- K062093: Avea Ventilator (2006), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own

## Indications for use
The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

Source page: https://510kreport.com/device/K031745
Methodology: https://510kreport.com/methodology