# K092085: Ispira Resuscitation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Oct 7, 2009 after 90 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: 4 generations back to K862830 (1986). 14 ancestors in all.
4 later devices descend from it; 3 cite 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.
- K080692: Macs Cpap System, Airon Corporation (2008) Summary page 1.
- K053140: Ambu Mark IV Resuscitator, Ambu A/S (2005) 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
- K142096: T-Piece Resuscitator (2014), 0 descendants of its own
- K122627: Gio Digital Pressure Guages (2013), 0 descendants of its own

## Indications for use
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube. The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.

Source page: https://510kreport.com/device/K092085
Methodology: https://510kreport.com/methodology