510(k) · Cleared
ClearedOxylog 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 Aug 25, 1995 after a 400-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 of the 138 devices in its family, counting itself, have a Class I recall. 137 later devices descend from it.
- Decided
- Aug 25, 1995
- Review
- 400 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 1 citing it directly. 45 of the 138 devices in this family, counting this one, have a Class I recall.
- This deviceK943531 Oxylog 2000Drager, Inc. · 1995
- Descendant · cites it directly · 136 of its ownK981668 Smartvent 201 Portable VentilatorVersamed, Ltd. · 1999
- Descendant · 2 generations on · 134 of its ownK011957 Ivent 201 Portable VentilatorVersamed, Ltd. · 2001
- Descendant · 3 generations on · 123 of its ownK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 5 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 137 · See all- K981668Smartvent 201 Portable VentilatorVersamed, Ltd. · 1999 · cites it directly136descendants
- K011957Ivent 201 Portable VentilatorVersamed, Ltd. · 2001 · 2 generations on134descendants
- K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004 · 3 generations on123descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 5 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943531 | Oxylog 2000 | Drager, Inc. | 1995 | — |
| +1 | K981668 | Smartvent 201 Portable Ventilator | Versamed, Ltd. | 1999 | — |
| +2 | K011957 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2001 | — |
| +3 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 1 |
| 2007 | 2 | 1 |
| 2008 | 7 | 2 |
| 2009 | 5 | 1 |
| 2010 | 4 | 1 |
| 2011 | 13 | 8 |
| 2012 | 13 | 5 |
| 2013 | 10 | 4 |
| 2014 | 7 | 1 |
| 2015 | 9 | 2 |
| 2016 | 7 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
45 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (137)
See all 1371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981668 | Smartvent 201 Portable Ventilator | 1999 | 136 |
Has anything in its family been recalled? (45 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.
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K152068Astral 100/150Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
Nearest 12 of 45 shown.
Nearest 5 of 45; all are on the web page.
What does this lineage say?
- Of its descendants, K981668 (Versamed, Ltd., 1999) has gone furthest, with 136 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) | — |
https://510kreport.com/device/K943531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943531: 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/K943531
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026