# K153387: Luna CPAP and Auto CPAP System

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Sep 8, 2016 after 290 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: 6 generations back to K953930 (1996). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141770: Luna Cpap and Auto-Cpap System, 3B Medical, Inc. (2015) Summary page 5.

## Most influential descendants
- K253044: RXiBreeze PAP System (RXiBreeze 20C) (2026), 0 descendants of its own
- K211155: Auto CPAP System (2022), 0 descendants of its own

## Indications for use
The Luna® CPAP and Auto CPAP System are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated heated humidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

Source page: https://510kreport.com/device/K153387
Methodology: https://510kreport.com/methodology