# K072021: Neopip Infant Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Sep 12, 2007 after 51 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: 1 generation back to K892885 (1989). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own
- 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 Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.

Source page: https://510kreport.com/device/K072021
Methodology: https://510kreport.com/methodology