510(k) · Cleared
ClearedHri 6500, 6600 and 6700 Series V2MASKS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Rudolph, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 1, 2008 as substantially equivalent to K023135 (Respironics, Inc., 2003) and 8 other predicates after a 283-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Feb 1, 2008
- Review
- 283 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K936047 (1995). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 3 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 2 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 1 generation backK030822 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksHans Rudolph, Inc. · 2003
- This deviceK071149 Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143603 Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −3 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −2 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −1 | K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks | Hans Rudolph, Inc. | 2003 | — |
| 0 (this device) | K071149 | Hri 6500, 6600 and 6700 Series V2MASKS | Hans Rudolph, Inc. | 2008 | — |
| +1 | K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | Resmed, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…TM Predicates 6600 and 6700 Series V2masksTM Predicates Respironics image3 SE Disposable Full-Face Mask Respironics Image3 Disposable Full-Face Mask (K023135) (K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full… | 2003 |
| * | K023244 | Mirage Full Face Mask Series 2Summary page 1…sk (K023135) (K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full Face Mask (K041362) ries 2 (K023244, K023284, and K023306) Hans Rudolph 7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patient Multi-Use NIV… | 2002 |
| * | K023284 | Mirage Full Face Mask Series 2Summary page 1…35) (K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full Face Mask (K041362) ries 2 (K023244, K023284, and K023306) Hans Rudolph 7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patient Multi-Use NIV Mask (K03… | 2002 |
| * | K023306 | Mirage Full Face Mask Series 2Summary page 1…(K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full Face Mask (K041362) ries 2 (K023244, K023284, and K023306) Hans Rudolph 7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patient Multi-Use NIV Mask (K0305 15)… | 2002 |
| * | K030515 | Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksSummary page 1…ace Mask (K041362) ries 2 (K023244, K023284, and K023306) Hans Rudolph 7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patient Multi-Use NIV Mask (K0305 15) Oro-Nasal CPAP/NIPPV Masks (K030822 and K0… | 2003 |
| * | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Summary page 1…ksTM Predicates Respironics image3 SE Disposable Full-Face Mask Respironics Image3 Disposable Full-Face Mask (K023135) (K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full Face Mask (K041362) ries 2 (K023244, K023284, and K02… | 2000 |
| * | K041362 | Resmed Hospital Full Face MaskSummary page 1…able Full-Face Mask (K023135) (K002465) ResMed Mirage Non-Vented Full Face Mask Se- ResMed Hospital Full Face Mask (K041362) ries 2 (K023244, K023284, and K023306) Hans Rudolph 7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patie… | 2004 |
| * | K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksSummary page 1…7500 Series Reusable Oro-Nasal Hans Rudolph 7600 Series Multi-Patient Multi-Use NIV Mask (K0305 15) Oro-Nasal CPAP/NIPPV Masks (K030822 and K020759) The V2masks TM possess the same intended use, indications for… | 2003 |
| * | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640…Summary page 1…Multi-Patient Multi-Use NIV Mask (K0305 15) Oro-Nasal CPAP/NIPPV Masks (K030822 and K020759) The V2masks TM possess the same intended use, indications for use, and intended patient population as these predicate devices.… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K143603 (Resmed, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K023135.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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…
Read the full statement (415 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071149 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071149: Hri 6500, 6600 and 6700 Series V2MASKS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071149
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026