# K151120: Simple T Pediatric Nasal Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Apr 15, 2016 after 354 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K902859 (1991). 34 ancestors in all.
No later device cites it as a predicate yet.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140268: Simple T Youth Nasal Mask, Respironics, Inc. (2014) Summary page 4.
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 4.

## Indications for use
This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.

Source page: https://510kreport.com/device/K151120
Methodology: https://510kreport.com/methodology