# K231313: Therapy Mask 3100 NC/SP

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jul 28, 2023 after 84 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: 2 generations back to K140268 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210386: Magneto Nasal Mask, Respironics, Inc. (2021) Summary page 4.

## Indications for use
This 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 and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K231313
Methodology: https://510kreport.com/methodology