510(k) · Cleared
Recalled · Class I · 2023Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 6, 2011 as substantially equivalent to K984577 (Drager, Inc., 1999) and 2 other predicates after a 300-day review. Its family tree reaches back 7 generations to 1997. 3 of the 20 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Oct 6, 2011
- Review
- 300 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4 (4 Class I)
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962603 (1997). 17 ancestors in all, the oldest K943531 (1995). 2 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 · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 4 generations backK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
- 3 generations backK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- 2 generations backK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
- 1 generation backK082600 Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic…Draeger Medical B.V. · 2008 · Recalled (Class I)
- This deviceK103625 Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK121886 Savina 300 Savina 300, Country VariantsDraeger Medical GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK180779 Savina 300Dragerwerk AG & CO Kgaa · 2019
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −4 | K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2003 | — |
| −3 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| −2 | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | Class I |
| −1 | K082600 | Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model… | Draeger Medical B.V. | 2008 | Class I |
| 0 (this device) | K103625 | Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device | Draeger Medical Systems, Inc. | 2011 | — |
| +1 | K121886 | Savina 300 Savina 300, Country Variants | Draeger Medical GmbH | 2014 | — |
| +2 | 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 |
|---|---|---|
| 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? (3)
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 2…alence: The new Oxylog 3000 plus has been compared to the following 3 predicative devices: the Oxylog 2000 plus (K082600), the Oxylog 3000 (K062267) and the Oxylog 2000 (K984577). All 4 devices are intended to be used for patients for emergency and transport. All devices contain the equivalent set of venti… | 1999 |
| * | K062267 | Oxylog 3000Summary page 2…the 510(k): Substantial Equivalence: The new Oxylog 3000 plus has been compared to the following 3 predicative devices: the Oxylog 2000 plus (K082600), the Oxylog 3000 (K062267) and the Oxylog 2000 (K984577). All 4 devices are intended to be used for patients for emergency and transport. All devices conta… | 2006 |
| * | K082600 | Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Summary page 2…Brauer Reason for the 510(k): Substantial Equivalence: The new Oxylog 3000 plus has been compared to the following 3 predicative devices: the Oxylog 2000 plus (K082600), the Oxylog 3000 (K062267) and the Oxylog 2000 (K984577). All 4 devices are intended to be used for patients for emergency and t… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121886 | Savina 300 Savina 300, Country Variants | 2014 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2023 | Class I | Z-2018-2023 | Device Design | Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation. |
| 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. |
| Mar 5, 2014 | Class I | Z-1440-2014 | Process control | The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged. |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K121886 (Draeger Medical GmbH, 2014) has gone furthest, with 1 descendant 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. 2011, 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 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards.
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/K103625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103625: Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103625
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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