# K212263: Luna G3 BPAP System

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Mar 25, 2022 after 248 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: 12 generations back to K953930 (1996). 36 ancestors in all.
No later device cites it as a predicate yet.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201620: Luna® G3 BPAP 25A, 3B Medical, Inc. (2021) Summary page 4.

## Indications for use
The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

Source page: https://510kreport.com/device/K212263
Methodology: https://510kreport.com/methodology