510(k) · Cleared
ClearedIMAGE3 SE Disposable Full Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 3, 2003 as substantially equivalent to K002465 (Respironics, Inc., 2000) after a 105-day review. Its family tree reaches back 1 generation to 2000. 4 of the 30 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Jan 3, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002465 (2000). 28 later devices descend from it, 7 citing it directly. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002465 Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Respironics, Inc. · 2000
- This deviceK023135 IMAGE3 SE Disposable Full Face MaskRespironics, 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 · cites it directly · 7 of its ownK072588 Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 7 of its ownK060044 Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006
- Descendant · 2 generations on · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081743 Classicstar NV SE and Novastar NV SE and Aav…cites it directly · 2008
- 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
Most influential descendants
Showing 5 of 28 · See all- K062019Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2006 · cites it directly8descendants
- K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly7descendants
- K060044Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006 · cites it directly7descendants
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 generations on6descendants
- K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 | Respironics, Inc. | 2000 | — |
| 0 (this device) | K023135 | IMAGE3 SE Disposable Full Face Mask | Respironics, Inc. | 2003 | — |
| +1 | K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD | Innomed Technologies, Inc./Respcare, Inc. | 2006 | — |
| +1 | K072588 | Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K060044 | Acute Care Face Mask, Model RT040 | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| +2 | K063806 | Sleepnet Mojo -NV Full Face Mask, Non-Vented | Sleepnet Corporation | 2007 | Class I |
| +2 | K092648 | Respironics Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 1 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Summary page 1…Anesthesiology Devices Product Code CBK - Ventilator, Continuous Predicate Device Spectrum 2 Full Face Mask (K002465) Reason for submission Modified design 02002 Respironics Inc. 1/2/03 === P… | 2000 |
What descends from it? (28)
See all 287 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD | 2006 | 8 |
| K072588 | Performax SE Total Face Mask | 2007 | 7 |
| K060044 | Acute Care Face Mask, Model RT040 | 2006 | 7 |
| K083122 | Hospital Full Face Mask Non Vented, Model: RT041 | 2009 | 4 |
| K071149 | Hri 6500, 6600 and 6700 Series V2MASKS | 2008 | 1 |
| K081670 | The Advantage Series Non-Vented (NV) Full Face Mask | 2008 | 0 |
| K081743 | Classicstar NV SE and Novastar NV SE and Aav Full Face Masks Class I | 2008 | 0 |
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.
- K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- 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
What does this lineage say?
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 Image3 SE Disposable Full Face Mask is 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 CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.
The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023135: IMAGE3 SE Disposable Full Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023135
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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