# K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks

- Pathway: 510(k) (Traditional)
- Applicant: Hans Rudolph, Inc.
- Decided: May 2, 2003 after 72 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
No predicates in its family tree.
11 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD (2006), 8 descendants of its own
- 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
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS (2008), 1 descendant of its own

## Indications for use
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are 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 positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting.

Source page: https://510kreport.com/device/K030515
Methodology: https://510kreport.com/methodology