# K211155: Auto CPAP System

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Mar 9, 2022 after 324 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: 10 generations back to K913396 (1992). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153387: Luna CPAP and Auto CPAP System, 3B Medical, Inc. (2016) Summary page 4.
- K160836: Menai System, Resmed, Ltd. (2016) Summary page 4.

## Indications for use
Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home. Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use. LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.

Source page: https://510kreport.com/device/K211155
Methodology: https://510kreport.com/methodology