510(k) · Cleared
Cleared7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit
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 Aug 13, 2002 as substantially equivalent to K982530 (Resmed, Ltd., 1998) and 2 other predicates after a 159-day review. Its family tree reaches back 2 generations to 1995. 8 of the 30 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 159 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K936047 (1995). 3 ancestors in all. 26 later devices descend from it, 3 citing it directly. 8 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 1 generation backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- This deviceK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- Descendant · cites it directly · 21 of its ownK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 20 of its ownK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
- Descendant · 3 generations on · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
- Descendant · 3 generations on · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005 · cites it directly21descendants
- K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation · 2006 · 2 generations on20descendants
- K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on7descendants
- K153673AirFit N20Resmed, Ltd. · 2016 · 4 generations on6descendants
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −1 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| 0 (this device) | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| +1 | K043382 | TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005 | — |
| +2 | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model… | Sleepnet Corporation | 2006 | — |
| +3 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| +4 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| +3 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 2 | 2 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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.
8 devices in this family have a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K982530 | Sullivan Mirage Full Face MaskSummary page 1…6. Substantial Equivalence: The Hans Rudolph 7600 Series Reusable Full-Face CPAPNIPPV Masks are substantially equivalent to the ResMed Sullivan7 MirageTM Full Face Mask (K982530), Respironics SpectrumTM Disposable Full Face Masks (K936047), and the Respironics SpectrumTMReusable Full Face Masks (K96 19 15)… | 1998 |
| * | K936047 | Spectrum (TM) MaskSummary page 1…able Full-Face CPAPNIPPV Masks are substantially equivalent to the ResMed Sullivan7 MirageTM Full Face Mask (K982530), Respironics SpectrumTM Disposable Full Face Masks (K936047), and the Respironics SpectrumTMReusable Full Face Masks (K96 19 15). 1 ===… | 1995 |
| * | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeSummary page 1…ResMed Sullivan7 MirageTM Full Face Mask (K982530), Respironics SpectrumTM Disposable Full Face Masks (K936047), and the Respironics SpectrumTMReusable Full Face Masks (K96 19 15). 1 The characteristics of the Hans Rudolph 7600 Series Reus… | 1996 |
What descends from it? (26)
See all 263 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K120463Mojo, VerasealSleepnet Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K043382 (Tiara Medical Systems, Inc., 2005) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K982530.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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…
Read the full statement (145 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020759
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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