# K172284: NAPA LP-15 Airway Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Drw Medical, LLC
- Decided: Feb 9, 2018 after 196 days
- Product code: CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm))
- Device class: 2
- Regulation: 21 CFR 868.2600
- 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 K871083 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992101: Criterion 40 or PM 40, Caradyne, Ltd. (2000) Summary page 4.

## Indications for use
The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor mean airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.

Source page: https://510kreport.com/device/K172284
Methodology: https://510kreport.com/methodology