# K201620: Luna® G3 BPAP 25A

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Jan 29, 2021 after 228 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: 11 generations back to K953930 (1996). 35 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133769: 3B Resmart Bpap 25A, BMC Resmart Bpap 25A, 3B Medical, Inc. (2014) Summary page 4.
- K131982: Remstar Auto a-Flex HT, Respironics, Inc. (2013) Summary page 5.

## Most influential descendants
- K213169: BPAP System (2022), 0 descendants of its own
- K212263: Luna G3 BPAP System (2022), 0 descendants of its own

## Indications for use
The Luna® G3 BPAP 25A 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 >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

Source page: https://510kreport.com/device/K201620
Methodology: https://510kreport.com/methodology