# K974879: Model 7410 Voyager

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne Technologies, Inc.
- Decided: Jun 29, 1998 after 181 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.
93 later devices descend from it; 1 cites it directly.
12 of 94 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
- K012554: Remstar Auto Cpap System (2002), 92 descendants of its own
- K031460: Modification to Remstar Auto Cpap System (2003), 74 descendants of its own
- K021861: Remstar Pro with C-Flex Cpap System (2002), 47 descendants of its own
- K052110: M-Series Pro Cpap Sytem (2005), 42 descendants of its own
- K041010: Remstar Auto with C-Flex Cpap System (2004), 40 descendants of its own

## Indications for use
The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.

Source page: https://510kreport.com/device/K974879
Methodology: https://510kreport.com/methodology