# K030822: 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks

- Pathway: 510(k) (Traditional)
- Applicant: Hans Rudolph, Inc.
- Decided: Jun 3, 2003 after 81 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: 3 generations back to K936047 (1995). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit, Hans Rudolph, Inc. (2002) Summary page 1.

## Most influential descendants
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS (2008), 1 descendant of its own
- K143603: Darlinghurst Vented, Darlinghurst NV-AAV (2015), 0 descendants of its own
- K052249: Utopia (2005), 0 descendants of its own

## Indications for use
The Hans Rudolph 7600 Vmask series are reusable, multi-patient multi-use, adult Oro-Nasal CPAP/NPPV masks which incorporate a passive, continuous flow exhaust port at the patient connection. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cm HzO pressure measured at the mask. The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures 2 3.0 cm H20 at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

Source page: https://510kreport.com/device/K030822
Methodology: https://510kreport.com/methodology