# K102120: Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Co., Ltd.
- Decided: Aug 12, 2011 after 379 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003894 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235, Hsiner Co., Ltd. (2007) Summary page 1.
- K083122: Hospital Full Face Mask Non Vented, Model: RT041, Fisher & Paykel Healthcare, Ltd. (2009) Summary page 2.

## Indications for use
The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure, These masks are intended for use with spontaneously-breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for noninvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate or severe dyspnea; elevated respiratory rates, labored breathing, or paradoxical breathing).

Source page: https://510kreport.com/device/K102120
Methodology: https://510kreport.com/methodology