# K111378: Oximetry Interface Kit

- Pathway: 510(k) (Traditional)
- Applicant: Philips Respironics, Inc.
- Decided: Oct 4, 2011 after 140 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: 11 generations back to K953930 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
4 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102465: Bipap Avaps Ventilatory Support System, Respironics, Inc. (2011) Summary page 2.
- K092818: Bipap Avaps Ventilatory Support System, Respironics, Inc. (2010) Summary page 2.

## 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 Oximerry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP SIT) ventilators to measure functional oxygen saturation of arterial hemoglobin (%Sp02) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment. The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP SIT) is intended to provide non-invasive Ventilatory support to treat adult and pediatric (> 7 years of ages; > I8 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.

Source page: https://510kreport.com/device/K111378
Methodology: https://510kreport.com/methodology