# K990574: Stick-on Disposable Nasal Mask, Model 312174, 1001964

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: May 24, 1999 after 90 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K833786 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951264: Bipap Model S/T-D, Respironics, Inc. (1996) Summary page 1.

## Indications for use
The Respironics Stick-On Disposable Nasal Mask is intended to provide an interface for application of Respironics BiPAP and CPAP support therapy to patients. For short-term, single use in a hospital or institutional environment. The mask is to be used on adult patients (> 30kg) under the following conditions: Patients for whom BiPAP or CPAP has been prescribed, using a Respironics BiPAP or CPAP system. Intact, external skin surfaces only.

Source page: https://510kreport.com/device/K990574
Methodology: https://510kreport.com/methodology