510(k) · Cleared
ClearedHans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Rudolph, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on May 2, 2003 after a 72-day review. The FDA summary names no predicate by number. 4 of the 12 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly. 4 of the 12 devices in this family, counting this one, have a Class I recall.
- This deviceK030515 Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksHans Rudolph, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK062019 Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK102317 IQ Ventilation Nasal MaskSleepnet Corporation · 2011
- Descendant · 3 generations on · 1 of its ownK190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face…Sleepnet Corporation · 2019 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK071149 Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc. · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K063806 Sleepnet Mojo -NV Full Face Mask, Non-Vented2 generations on · 2007
- K170037 Breathe Technologies Life2000™ Ventilation System2 generations on · 2017
- K190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV…3 generations on · 2019
- K081743 Classicstar NV SE and Novastar NV SE and Aav…3 generations on · 2008
Most influential descendants
Showing 5 of 11 · See all- K062019Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2006 · cites it directly8descendants
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 generations on6descendants
- K102317IQ Ventilation Nasal MaskSleepnet Corporation · 2011 · 3 generations on2descendants
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation · 2019 · 3 generations on1descendant
- K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030515 | Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks | Hans Rudolph, Inc. | 2003 | — |
| +1 | K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD | Innomed Technologies, Inc./Respcare, Inc. | 2006 | — |
| +2 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
| +3 | K102317 | IQ Ventilation Nasal Mask | Sleepnet Corporation | 2011 | — |
| +3 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask… | Sleepnet Corporation | 2019 | Class I |
| +1 | K071149 | Hri 6500, 6600 and 6700 Series V2MASKS | Hans Rudolph, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2021 | 1 | 0 |
| 2024 | 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.
4 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- 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
What does this lineage say?
- Of its descendants, K062019 (Innomed Technologies, Inc./Respcare, Inc., 2006) has gone furthest, with 8 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030515: Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030515
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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