# K083122: Hospital Full Face Mask Non Vented, Model: RT041

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 4, 2009 after 133 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003894 (2001). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060044: Acute Care Face Mask, Model RT040, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.
- K023135: IMAGE3 SE Disposable Full Face Mask, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- K173060: F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (2018), 2 descendants of its own
- K203449: F&P Visairo NIV Mask Range (2021), 1 descendant of its own
- K252173: F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (2025), 0 descendants of its own
- K102120: Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202 (2011), 0 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare RT041 Hospital Full Face Mask Non Vented is a patient interface for use as an accessory to a respiratory therapy device, i.e. ventilator that has adequate alarms and safety systems for ventilator failure, providing noninvasive positive pressure respiratory therapy. The mask is for single patient use with spontaneously breathing adult (> 30 kg) patients with respiratory insufficiency or respiratory failure who are suitable for noninvasive pressure support ventilation in hospital/institutional environments only.

Source page: https://510kreport.com/device/K083122
Methodology: https://510kreport.com/methodology