# K171961: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Compower Medical Tech. Co., Ltd.
- Decided: Nov 17, 2017 after 140 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K861401 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142764: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port, Hangzhou Jinlin Medical Appliances Co., Ltd. (2015) Summary page 8.
- K983919: Ems Mouth to Mask Resuscitators, Engineered Medical Systems (1999) Summary page 8.
- K152521: Seal Rite Non-Rebreathing Valve, The Lifeguard Store, Inc. (2016) Summary page 8.

## Indications for use
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use. The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use. The Infant CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR Mask is indicated for use on infants with body weight up to 10 kg (22 Ibs). The Infant CPR Mask is intended for over-the-counter use. The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use. The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.

Source page: https://510kreport.com/device/K171961
Methodology: https://510kreport.com/methodology