# K152810: DeVilbiss DV6WM Wireless Modem

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Healthcare, LLC
- Decided: Jan 21, 2016 after 115 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082209: Devilbiss DV5M Smartlink System, Sunrise Medical (2008) Summary page 4.
- K093684: Easycare Online, Resmed, Ltd. (2010) Summary page 4.

## Indications for use
The DeVilbiss Healthcare DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module, IntelliPAP2, and DeVilbiss Blue Series CPAPs for patients in a home or healthcare environment. It is not intended to be used as a diagnostic tool.

Source page: https://510kreport.com/device/K152810
Methodology: https://510kreport.com/methodology