# K060044: Acute Care Face Mask, Model RT040

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Apr 6, 2006 after 90 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- 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: 4 generations back to K003894 (2001). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040506: Flexifil Series HC431 Full Face Mask, Model HC431A, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.
- K023135: IMAGE3 SE Disposable Full Face Mask, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- K083122: Hospital Full Face Mask Non Vented, Model: RT041 (2009), 4 descendants of its own
- 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
- K170367: Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small (2017), 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

## Indications for use
The Fisher & Paykel Healthcare Acute Care Single Use Face Mask is a nasal-oral patient interface for use as an accessory to ventilators providing noninvasive bi-level and constant positive airway pressure ventilation. The ventilator must have adequate alarms and safety systems for ventilator failure. 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 the hospital/institutional environments only.

Source page: https://510kreport.com/device/K060044
Methodology: https://510kreport.com/methodology