510(k) · Cleared
ClearedDrager Oxylog 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 22, 1999 after a 30-day review. The FDA summary names its predicate without a number. 11 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- Jan 22, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly. 11 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK984577 Drager Oxylog 2000Drager, Inc. · 1999
- Descendant · cites it directly · 20 of its ownK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 3 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K062267Oxylog 3000Drager Medical B.V. · 2006 · cites it directly20descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 2 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on8descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984577 | Drager Oxylog 2000 | Drager, Inc. | 1999 | — |
| +1 | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | Class I |
| +2 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +3 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| +4 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +5 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2008 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 5 | 2 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 2 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2023 | 1 | 0 |
| 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.
11 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 |
|---|---|---|---|
| * | — | Oxylog 2000 Named without a submission number |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 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.
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- Of its descendants, K062267 (Drager Medical B.V., 2006) has gone furthest, with 20 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 Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL.
With applications in:
mobile emergency and primary care of emergency patients
patient transports in emergency rescue vehicles or by helicopter
patient transfers by road or air
inner hospital transport of ventilated patients
emergency room
secondary transports between hospitals
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984577: Drager Oxylog 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984577
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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