# K945740: Infant Flow System

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical, Inc.
- Decided: Mar 23, 1995 after 120 days
- Product code: BZO (Set, Tubing And Support, Ventilator (W Harness))
- Device class: 1
- Regulation: 21 CFR 868.5975
- Recalls of this device: 3 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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

## Recalls of this device
- Jun 1, 2015 · Class II · Z-1964-2015: An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventila
- Jun 1, 2015 · Class II · Z-1963-2015: An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventila
- Jun 1, 2015 · Class II · Z-1965-2015: An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventila

Source page: https://510kreport.com/device/K945740
Methodology: https://510kreport.com/methodology