# K053168: Bipap Focus

- Pathway: 510(k) (Traditional)
- Applicant: Respironics (Ireland) Limited
- Decided: Jan 4, 2006 after 51 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833786 (1983). 15 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 4.
- K984407: Bipap Harmony S/T, Model 1001445, Respironics, Inc. (1999) Summary page 4.
- K031656: Bipap Harmony Ventilatory Support System, Respironics, Inc. (2003) Summary page 4.

## Most influential descendants
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K090398: Provent Professional Sleep Apnea Therapy (2009), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own

## Recalls of this device
- Sep 22, 2008 · Not classified · Z-1606-2009: Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's p

## Indications for use
The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

Source page: https://510kreport.com/device/K053168
Methodology: https://510kreport.com/methodology