# K210386: Magneto Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 12, 2021 after 153 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: 1 generation back to K140268 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
2 of 3 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.

## Most influential descendants
- K231313: Therapy Mask 3100 NC/SP (2023), 0 descendants of its own

## Recalls of this device
- Sep 6, 2022 · Class I · Z-1784-2022: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

## 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 Ibs) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K210386
Methodology: https://510kreport.com/methodology