# K011516: Infant Flow System, Model M672P

- Pathway: 510(k) (Traditional)
- Applicant: Eme (Electro Medical Equipment), Ltd.
- Decided: Jun 8, 2001 after 22 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.
33 later devices descend from it; 3 cite it directly.
9 of 34 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
- K031745: Infant Flow Plus Infant Cpap System with Sipap Function (2004), 22 descendants of its own
- 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

Source page: https://510kreport.com/device/K011516
Methodology: https://510kreport.com/methodology