# K081743: Classicstar NV SE and Novastar NV SE and Aav Full Face Masks

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Sep 22, 2008 after 95 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936047 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023135: IMAGE3 SE Disposable Full Face Mask, Respironics, Inc. (2003) Summary page 2.
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented, Sleepnet Corporation (2007) Summary page 2.
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837, Sleepnet Corporation (2006) Summary page 2.

## Recalls of this device
- Jan 23, 2023 · Class I · Z-1138-2023: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
- Jan 23, 2023 · Class I · Z-1137-2023: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

## Indications for use
The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (NV) with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that 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 or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask ClassicStar NV, with standard elbow is disposable and for single patient use. The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times. The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH20). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Source page: https://510kreport.com/device/K081743
Methodology: https://510kreport.com/methodology