# K082209: Devilbiss DV5M Smartlink System

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Oct 28, 2008 after 84 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102465: Bipap Avaps Ventilatory Support System (2011), 1 descendant of its own
- K152810: DeVilbiss DV6WM Wireless Modem (2016), 0 descendants of its own
- K140880: Devilbiss Smartlink II System (2014), 0 descendants of its own
- K111378: Oximetry Interface Kit (2011), 0 descendants of its own

## Indications for use
The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.

Source page: https://510kreport.com/device/K082209
Methodology: https://510kreport.com/methodology