# K063036: Opus HC482 Direct Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Dec 22, 2006 after 80 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K952292 (1995). 25 ancestors in all.
24 later devices descend from it; 5 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.
- K061236: Flexifit HC432 Full Face Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.
- K050904: Cpap Humidifier, Model HC238JHU, Fisher & Paykel Healthcare, Ltd. (2005) Summary page 1.

## Most influential descendants
- K080209: Fisher and Paykel Healthcare Zest Nasal Mask (2008), 15 descendants of its own
- K083832: Zest Nasal Mask (2009), 14 descendants of its own
- K120027: Pilairo Nasal Pillows Mask (2012), 7 descendants of its own
- K161412: F&P Brevida™ Nasal Pillows Mask (2017), 6 descendants of its own
- K200089: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (2020), 5 descendants of its own

## Indications for use
The Opus HC482 Direct Nasal Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting.

Source page: https://510kreport.com/device/K063036
Methodology: https://510kreport.com/methodology