# K021716: Simplify Compact Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Polymed (Xiamen) Plastic Industrial Co., Ltd.
- Decided: Oct 8, 2002 after 138 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 SIMPLIFY COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The SIMPLIFY COMPACT RESUSCITATOR provided in reusable models and in the disposable models.

Source page: https://510kreport.com/device/K021716
Methodology: https://510kreport.com/methodology