# K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit

- Pathway: 510(k) (Traditional)
- Applicant: Hans Rudolph, Inc.
- Decided: Aug 13, 2002 after 159 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: 2 generations back to K936047 (1995). 3 ancestors in all.
26 later devices descend from it; 3 cite it directly.
8 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982530: Sullivan Mirage Full Face Mask, Resmed, Ltd. (1998) Summary page 1.
- K936047: Spectrum (TM) Mask, Respironics, Inc. (1995) Summary page 1.
- K961915: Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (2005), 21 descendants of its own
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837 (2006), 20 descendants of its own
- K132887: Airfit N10 (2013), 7 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), 6 descendants of its own

## Indications for use
The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAp/"PV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is 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 cmH.20 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 HzO at the mask) in homes, hospitals, and 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/K020759
Methodology: https://510kreport.com/methodology