# K102542: Resusci Flow; Resusci Flow 104

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Apr 6, 2011 after 215 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K760102 (1976). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has 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.
- K070210: Giraffe and Panda  T- Piece Resuscitation System, Ohmeda Medical (2007) Summary page 1.

## Indications for use
The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP). The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure. All are intended for neonates and infants (< 10kg or 22 Ibs) in a delivery room and a NICU.

Source page: https://510kreport.com/device/K102542
Methodology: https://510kreport.com/methodology