# K121631: Simple T Nasal Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Oct 5, 2012 after 123 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: 6 generations back to K945938 (1996). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120145: Simple T Nasal Mask, Respironics, Inc. (2012) Summary page 1.
- K110008: Golife Nasal Mask, Respironics, Inc. (2011) Summary page 1.

## Most influential descendants
- K140980: TI Nasal Mask (2015), 2 descendants of its own
- 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-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 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.

Source page: https://510kreport.com/device/K121631
Methodology: https://510kreport.com/methodology