# K140980: TI Nasal Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Feb 10, 2015 after 300 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
Longest line of descent: 7 generations back to K945938 (1996). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122847: Kangaroo Nasal Mask, Respironics, Inc. (2013) Summary page 5.
- K121631: Simple T Nasal Mask, Respironics, Inc. (2012) Summary page 5.
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 5.

## Most influential descendants
- K210844: DreamWear Silicone Pillows Mask (2021), 1 descendant of its own
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## Recalls of this device
- Sep 6, 2022 · Class I · Z-1782-2022: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

## Indications for use
The TI 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 on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K140980
Methodology: https://510kreport.com/methodology