# K071149: Hri 6500, 6600 and 6700 Series V2MASKS

- Pathway: 510(k) (Traditional)
- Applicant: Hans Rudolph, Inc.
- Decided: Feb 1, 2008 after 283 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: 4 generations back to K936047 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 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 1.
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023284: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K023306: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.
- K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks, Hans Rudolph, Inc. (2003) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.
- K041362: Resmed Hospital Full Face Mask, Resmed, Ltd. (2004) Summary page 1.
- K030822: 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks, Hans Rudolph, Inc. (2003) Summary page 1.
- 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
- K143603: Darlinghurst Vented, Darlinghurst NV-AAV (2015), 0 descendants of its own

## Indications for use
The 6500 Series V2masks are disposable, single-patient-use, adult oro-nasal masks intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to continuous ventilators which have adequate alarms and safety systems for ventilator failure. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. They are intended for use on patients who are appropriate candidates for noninvasive ventilation, in the home, hospital, 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. The 6600 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks which incorporate passive, continuous flow exhaust ports into the mask itself. 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 H 2 0 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 >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. The 6700 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks without any passive, continuous flow exhaust port built into the mask. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that incorporate the patient vent into the patient circuit instead of the mask. These masks provide a minimum of 3 cm H 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 >3.0 cm H 20 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/K071149
Methodology: https://510kreport.com/methodology