# K213169: BPAP System

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Dec 5, 2022 after 433 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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). 122 ancestors in all.
No later device cites it as a predicate yet.
6 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153061: Juno VPAP ST-A, Resmed, Ltd. (2016) Summary page 6.
- K201620: Luna® G3 BPAP 25A, 3B Medical, Inc. (2021) Summary page 6.

## Indications for use
The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K213169
Methodology: https://510kreport.com/methodology