# K982225: Spiracle Technology-BI-Flow Demand/Resuscitator Valve, Model 504

- Pathway: 510(k) (Traditional)
- Applicant: Spiracle Technology
- Decided: Oct 28, 1998 after 126 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. The FDA summary names its predicate without a number.
- (no number) Allied Healthcare Products (Life Support Products) CPR/Demand Valve Model 063: named in the summary without a submission number
- (no number) Allied Healthcare Products (Life Support Products) CPR/Demand Valve Model 063R: named in the summary without a submission number

## Indications for use
The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator thus providing emergency respiratory support. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his/her negative inspiratory force and the saurce gas being delivered to the patient through a face mask. Additionally, there is a non-rebreathing valve (reusable version or single patient use version) attached to the Bi-Flow D/R which directs the patient's exhalation back to atmosphere. The combination of the Bi-Flow D/R and the non—ebreathing valve as a single device is commonly referred to as a Demand Valve. The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device. The Bi-Flow D/R will be sold by Spiracle Technology only by or on the order of a physician and is intended to be used exclusively by trained health care professionals. The Bi-Flow D/R will be sold as a component of a respiratory support system to be configured by the health care provider. As such, it will be compatible with all commonly available oxygen source and face mask connections.

Source page: https://510kreport.com/device/K982225
Methodology: https://510kreport.com/methodology