# K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Technologies, Inc./Respcare, Inc.
- Decided: Aug 17, 2006 after 31 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: 2 generations back to K002465 (2000). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
4 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks, Hans Rudolph, Inc. (2003) Summary page 1.
- K023135: IMAGE3 SE Disposable Full Face Mask, Respironics, Inc. (2003) Summary page 1.

## Most influential descendants
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), 6 descendants of its own
- K102317: IQ Ventilation Nasal Mask (2011), 2 descendants of its own
- K190533: Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented (2019), 1 descendant of its own
- K241520: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask (2024), 0 descendants of its own
- K203601: Innova Nasal Non-Vented Mask (2021), 0 descendants of its own

## Indications for use
The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. (Applies to the standard version): For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

Source page: https://510kreport.com/device/K062019
Methodology: https://510kreport.com/methodology