# K973106: Golemb Disposable Bag Mask Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Allied Healthcare Products, Inc.
- Decided: Jan 29, 1998 after 163 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
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 Golemb Disposable Bag Mask Resuscitator is a single patient use system for manual resuscitation. The Golemb Disposable Bag Mask Resuscitator is designed to be used for adults, pediatrics, and infants. The primary intended use for the product is in the Emergency Medical Service (EMS) Industry; however, the product can be used when manual resuscitation is required.

Source page: https://510kreport.com/device/K973106
Methodology: https://510kreport.com/methodology