510(k) · Cleared
ClearedRespcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innomed Technologies, Inc./Respcare, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 17, 2006 as substantially equivalent to K030515 (Hans Rudolph, Inc., 2003) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 2000. 4 of the 12 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Aug 17, 2006
- Review
- 31 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002465 (2000). 3 ancestors in all. 8 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.
- Root · 2 generations backK002465 Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Respironics, Inc. · 2000
- 1 generation backK023135 IMAGE3 SE Disposable Full Face MaskRespironics, Inc. · 2003
- This deviceK062019 Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK102317 IQ Ventilation Nasal MaskSleepnet Corporation · 2011
- Descendant · 2 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 · 3 generations on · 0 of its ownK241520 Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented…Sleepnet Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK203601 Innova Nasal Non-Vented MaskSleepnet Corporation · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K063806 Sleepnet Mojo -NV Full Face Mask, Non-Ventedcites it directly · 2007
- K170037 Breathe Technologies Life2000™ Ventilation Systemcites it directly · 2017
- K190533 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV…2 generations on · 2019
- K081743 Classicstar NV SE and Novastar NV SE and Aav…2 generations on · 2008
Most influential descendants
Showing 5 of 8 · See all- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · cites it directly6descendants
- K102317IQ Ventilation Nasal MaskSleepnet Corporation · 2011 · 2 generations on2descendants
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation · 2019 · 2 generations on1descendant
- K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation · 2024 · 3 generations on0descendants
- K203601Innova Nasal Non-Vented MaskSleepnet Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 | Respironics, Inc. | 2000 | — |
| −1 | K023135 | IMAGE3 SE Disposable Full Face Mask | Respironics, Inc. | 2003 | — |
| 0 (this device) | K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD | Innomed Technologies, Inc./Respcare, Inc. | 2006 | — |
| +1 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
| +2 | K102317 | IQ Ventilation Nasal Mask | Sleepnet Corporation | 2011 | — |
| +2 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask… | Sleepnet Corporation | 2019 | Class I |
| +3 | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask… | Sleepnet Corporation | 2024 | — |
| +3 | K203601 | Innova Nasal Non-Vented Mask | Sleepnet Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2008 | 1 | 1 |
| 2011 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K030515 | Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksSummary page 1…Class II, CFR 868.5895, CBK Classification Name: Accessory to Continuous Ventilator Predicate Devices: K030515 - Hans Rudolph 7500 Vmask K023135 - Respironics lmage3 SE Device Description A specializ… | 2003 |
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…Accessory to Continuous Ventilator Predicate Devices: K030515 - Hans Rudolph 7500 Vmask K023135 - Respironics lmage3 SE Device Description A specialized interface for Non-Invasive Ventilation. Itwill be modeled after the Reap… | 2003 |
| † | K052227 | Respcare Face Mask | 2005 |
What descends from it? (8)
2 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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · Cites it directly · ◆ 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 · 2 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063806 (Sleepnet Corporation, 2007) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K030515.
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 Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for…
Read the full statement (134 words)
The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version):
The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062019
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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