# K013421: Lifeguard Nasal Cpap Mask and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lifeguard Medical Products, Inc.
- Decided: Jan 8, 2002 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide CPAP gas flow, and devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.

Source page: https://510kreport.com/device/K013421
Methodology: https://510kreport.com/methodology