# K974141: Plus Reusable Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Schiff & Co.
- Decided: May 21, 1998 after 199 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
Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.

Source page: https://510kreport.com/device/K974141
Methodology: https://510kreport.com/methodology