# K023135: IMAGE3 SE Disposable Full Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Jan 3, 2003 after 105 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: 1 generation back to K002465 (2000). 1 ancestor in all.
28 later devices descend from it; 7 cite it directly.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.

## Most influential descendants
- K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD (2006), 8 descendants of its own
- K072588: Performax SE Total Face Mask (2007), 7 descendants of its own
- K060044: Acute Care Face Mask, Model RT040 (2006), 7 descendants of its own
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), 6 descendants of its own
- K092648: Respironics Performax SE Total Face Mask (2009), 5 descendants of its own

## Indications for use
The Image3 SE Disposable Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

Source page: https://510kreport.com/device/K023135
Methodology: https://510kreport.com/methodology