# K251888: VPAP Pediatric Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Co., Ltd.
- Decided: Mar 12, 2026 after 265 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: 7 generations back to K833786 (1983). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101129: Esprit Ventilator with AF531 SE Full Face Mask, Respironics, Inc. (2010) Summary page 5.

## Indications for use
The mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is for single patient use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Source page: https://510kreport.com/device/K251888
Methodology: https://510kreport.com/methodology