# K102649: Neopop Infant Resuscitator with Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Jan 6, 2011 after 114 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862830 (1986). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.
- K072021: Neopip Infant Resuscitator, Neoforce Group, Inc. (2007) Summary page 1.
- K092085: Ispira Resuscitation Unit, Neoforce Group, Inc. (2009) Summary page 1.

## Most influential descendants
- K110119: Pressure Manometer (2011), 1 descendant of its own
- K122627: Gio Digital Pressure Guages (2013), 0 descendants of its own

## Indications for use
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.

Source page: https://510kreport.com/device/K102649
Methodology: https://510kreport.com/methodology