510(k) · Cleared
ClearedThe Advantage Series Non-Vented (NV) Full Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 207, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 9, 2008 as substantially equivalent to K023135 (Respironics, Inc., 2003) after a 118-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 9, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002465 (2000). No later device cites it as a predicate yet.
- 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 deviceK081670 The Advantage Series Non-Vented (NV) Full Face MaskCardinal Health 207, Inc. · 2008
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) | K081670 | The Advantage Series Non-Vented (NV) Full Face Mask | Cardinal Health 207, Inc. | 2008 | — |
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 CBK? 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 |
|---|---|---|---|
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…d (NV) Full Face Mask is substantially equivalent device equivalent to the following device: > Image3 SE Disposable Full Face Mask (K023135). THE ADVANTAGE SERIES® Non-vented (NV) Full Face has the following similari… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K023135.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 ADVANTAGE SERIES® Non-vented (NV) 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 ventilation 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 for use on adult patients (>30 kg) who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081670: The Advantage Series Non-Vented (NV) 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/K081670
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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