# K982454: Bipap Vision Ventilatory Support

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Nov 3, 1998 after 111 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K833786 (1983). 7 ancestors in all.
42 later devices descend from it; 7 cite it directly.
9 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955324: Bipap S/T-D 30 System, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K082660: V60 Ventilator, Model V8000 (2009), 14 descendants of its own
- K053168: Bipap Focus (2006), 11 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1057-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1085-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications. The BiPAP Vision is intended for use in a hospital environment (including sleep labs, respiratory care units) or alternate care site (e.g., transitional care centers, skilled nursing homes, ambulatory care centers) by respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician. The BiPAP Vision is used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and tracheal tube adapter), humidifiers, and circuit tubing.

Source page: https://510kreport.com/device/K982454
Methodology: https://510kreport.com/methodology