# K131098: Emergency Portable Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Allied Healthcare Products, Inc.
- Decided: Apr 9, 2014 after 356 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AHP3U0P is intended to be used as an electrically controlled emergency ventilator that requires an external compressed gas source. This ventilator Is designed to provide emergency respiratory support by means of a face mask or tube inserted Into the patients airway. The ventilator Is Intended for use on patients weighing greater than 5kg (11 ibs). The ventilator Is Intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. The ventilator Is Intended to be used in temperatures of -18 Cto SO C (OFto 122 F)and 5%to 95 % relative humidity non-condensing.

Source page: https://510kreport.com/device/K131098
Methodology: https://510kreport.com/methodology