510(k) · Cleared
Recalled · Class I · 2015Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical B.V. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 26, 2008 as substantially equivalent to K984577 (Drager, Inc., 1999) and 1 other predicate after a 79-day review. Its family tree reaches back 6 generations to 1997. 3 of the 20 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Nov 26, 2008
- Review
- 79 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962603 (1997). 16 ancestors in all, the oldest K943531 (1995). 3 later devices descend from it, 1 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 3 generations backK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
- 2 generations backK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- 1 generation backK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
- This deviceK082600 Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic…Draeger Medical B.V. · 2008
- Descendant · cites it directly · 2 of its ownK103625 Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK121886 Savina 300 Savina 300, Country VariantsDraeger Medical GmbH · 2014
- Descendant · 3 generations on · 0 of its ownK180779 Savina 300Dragerwerk AG & CO Kgaa · 2019
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · cites it directly2descendants
- K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH · 2014 · 2 generations on1descendant
- K180779Savina 300Dragerwerk AG & CO Kgaa · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −3 | K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2003 | — |
| −2 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| −1 | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | Class I |
| 0 (this device) | K082600 | Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model… | Draeger Medical B.V. | 2008 | — |
| +1 | K103625 | Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device | Draeger Medical Systems, Inc. | 2011 | Class I |
| +2 | K121886 | Savina 300 Savina 300, Country Variants | Draeger Medical GmbH | 2014 | — |
| +3 | K180779 | Savina 300 | Dragerwerk AG & CO Kgaa | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2014 | 1 | 0 |
| 2019 | 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.
3 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 |
|---|---|---|---|
| * | K984577 | Drager Oxylog 2000Summary page 1…d patients around the hospital; · In the recovery room. Legally marketed devices to which substantial equivalence is claimed: 510(k) Number Device Name K984577 Oxylog 2000 K062267 Oxylog 3000 type release status effective date number… | 1999 |
| * | K062267 | Oxylog 3000Summary page 1…· In the recovery room. Legally marketed devices to which substantial equivalence is claimed: 510(k) Number Device Name K984577 Oxylog 2000 K062267 Oxylog 3000 type release status effective date number organization p… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103625 | Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device Class I | 2011 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2015 | Class I | Z-0692-2016 | Device Design | Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. |
| Dec 22, 2015 | Class I | Z-0691-2016 | Device Design | Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. |
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.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K103625 (Draeger Medical Systems, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K984577.
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 Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082600 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082600: Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082600
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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