# K102465: Bipap Avaps Ventilatory Support System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 24, 2011 after 209 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K953930 (1996). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092818: Bipap Avaps Ventilatory Support System, Respironics, Inc. (2010) Summary page 2.
- K082209: Devilbiss DV5M Smartlink System, Sunrise Medical (2008) Summary page 2.
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink, Resmed, Ltd. (2003) Summary page 2.

## Most influential descendants
- K111378: Oximetry Interface Kit (2011), 0 descendants of its own

## Recalls of this device
- Jun 14, 2021 · Class I · Z-1973-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain c

## Indications for use
The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series therapy devices (BiPAP AVAPS and BiPAP SIT) to measure functional oxygen saturation of arterial hemoglobin (%SpO 2 ) and pulse rate for adult and pediatric patients. The Oximetry Module may be used in a hospital or home care environment. The Respironics BiPAP C Series Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 Ibs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C Series Ventilatory System may be used in the hospital or home.

Source page: https://510kreport.com/device/K102465
Methodology: https://510kreport.com/methodology