# K141770: Luna Cpap and Auto-Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Apr 22, 2015 after 295 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: 5 generations back to K953930 (1996). 12 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K132967: 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap, 3B Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K153387: Luna CPAP and Auto CPAP System (2016), 2 descendants of its own
- 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 3B Luna CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated 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/K141770
Methodology: https://510kreport.com/methodology