# K140268: Simple T Youth Nasal Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Oct 20, 2014 after 250 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
2 of 4 devices 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.

## Most influential descendants
- K210386: Magneto Nasal Mask (2021), 1 descendant of its own
- K231313: Therapy Mask 3100 NC/SP (2023), 0 descendants of its own
- K151120: Simple T Pediatric Nasal Mask (2016), 0 descendants of its own

## Recalls of this device
- Sep 6, 2022 · Class I · Z-1783-2022: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

## Indications for use
The Simple T Youth Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients 7 years or older (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K140268
Methodology: https://510kreport.com/methodology