# K242935: Respiration Data Management Software (PAP Link PC)

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Jan 15, 2025 after 112 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: 8 generations back to K971260 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140054: Rescan, Resmed, Ltd. (2014) Summary page 5.

## Indications for use
Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices’ settings. It is intended for healthcare professionals in healthcare facilities use only.

Source page: https://510kreport.com/device/K242935
Methodology: https://510kreport.com/methodology