# K130328: F&P Simplus Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare Limited
- Decided: Jun 5, 2013 after 114 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: 9 generations back to K952292 (1995). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 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.
- K121597: Eson Nasal Mask, Fisher & Paykel Healthcare Limited (2012) Summary page 1.

## Most influential descendants
- K190713: F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (2019), 1 descendant of its own
- K212371: F&P Evora Full Face Mask (2022), 0 descendants of its own

## Indications for use
The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Source page: https://510kreport.com/device/K130328
Methodology: https://510kreport.com/methodology