510(k) · Cleared
ClearedOption Niv, Model 8414115, Upgrade Kit Niv, Model 8414072
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medizintechnik GmbH · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 15, 2003 as substantially equivalent to K010093 (Drager Medizintechnik GmbH, 2001) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 2001. 7 of the 20 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Jan 15, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010093 (2001). 2 ancestors in all. 17 later devices descend from it, 2 citing it directly. 7 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010093 Non-Invasive Ventilation Niv Option, Model 84 14 474Drager Medizintechnik GmbH · 2001 · Recalled
- This deviceK023289 Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072Drager Medizintechnik GmbH · 2003
- Descendant · cites it directly · 15 of its ownK040642 Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa · 2004
- Descendant · 2 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 3 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 4 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa · 2004 · cites it directly15descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 2 generations on14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 3 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474 | Drager Medizintechnik GmbH | 2001 | 3 |
| 0 (this device) | K023289 | Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072 | Drager Medizintechnik GmbH | 2003 | — |
| +1 | K040642 | Lpo Option for Drager Intensive Care Ventilator Savina | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +2 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +3 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +4 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| +3 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 2 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 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.
7 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 |
|---|---|---|---|
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474Summary page 1…tinuous (per 21 CFR 868.5895) Legally marketed device to which Substantial Equivalence is claimed Evita 4 / Evita 2 dura with option NIV (K010093) Manufactured by Drager Medical AG & Co. KGaA Germany. Manufactured and Distributed in the United States by Drager Medical Inc.… | 2001 |
| * | K003068 | SavinaSummary page 1…2 dura with option NIV (K010093) Manufactured by Drager Medical AG & Co. KGaA Germany. Manufactured and Distributed in the United States by Drager Medical Inc. Savina (K003068) Manufactured by Drager Medical AG & Co. KGaA; Germany. Distributed in the United States by Drager Medical lnc.… | 2001 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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.
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 7; all are on the web page.
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?
Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023289
Report an extraction error
Are you the manufacturer?
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