510(k) · Cleared
Recalled · Class I · 2016Oxylog 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medical B.V. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 31, 2006 as substantially equivalent to K984577 (Drager, Inc., 1999) and 4 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1997. 11 of the 36 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Oct 31, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5 (3 Class I)
- Predicates
- 5
Its longest line of descent runs back 5 generations to K962603 (1997). 15 ancestors in all, the oldest K943531 (1995). 20 later devices descend from it, 5 citing it directly. 11 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
- 1 generation backK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- This deviceK062267 Oxylog 3000Drager Medical B.V. · 2006
- Descendant · cites it directly · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 2 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)
- Descendant · 4 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
- Descendant · 5 generations on · 3 of its ownK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K112006Hamilton-TC1Hamilton Medical AG · 2012 · cites it directly13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 2 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on8descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 4 generations on4descendants
- K161450Hamilton-C3Hamilton Medical AG · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2003 | — |
| −1 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | — |
| +1 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +2 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| +3 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +4 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
| +5 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 2 |
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 |
|---|---|---|
| 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? (5)
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…044 A1Drfgerand StefensCompany Predicate Devices: 510(k) Number Device Name K984577 Oxylog 2000 K040790 LTV 1000 K(003068 Savina K(942938 Crossvent-4 K… | 1999 |
| * | K040790 | Modification to LTV 1000 Ventilator/Breathing CircuitsSummary page 2…A1Drfgerand StefensCompany Predicate Devices: 510(k) Number Device Name K984577 Oxylog 2000 K040790 LTV 1000 K(003068 Savina K(942938 Crossvent-4 K(042468 Vent 201 K(04… | 2004 |
| * | K003068 | SavinaSummary page 2…tures of the LTV 1000 (K040790). The Oxylog 3000 incorporates a Pressure Controlled Ventilation plus mode and a Pressure Support mode identical to the Savina ventilator (K003068). Furthermore, the Oxylog 3000 uses the same operating principle as the Savina. Specific features and selling ranges of the Oxylo… | 2001 |
| * | K942938 | Crossvent-4 VentilatorSummary page 2…es the same operating principle as the Savina. Specific features and selling ranges of the Oxylog 3000 are found similar to those features on the Crossvent-4 ventilator (K942938) and the Vent 201 ventilator (K042468). The accessories of the Oxylog 3000 are similar to the accessories of the LTV 1000 (K04079… | 1995 |
| * | K042468 | Ivent 201 Portable VentilatorSummary page 2…Savina. Specific features and selling ranges of the Oxylog 3000 are found similar to those features on the Crossvent-4 ventilator (K942938) and the Vent 201 ventilator (K042468). The accessories of the Oxylog 3000 are similar to the accessories of the LTV 1000 (K040790) and the accessories of the Primus U… | 2004 |
| † | K042607 | Primus US | 2004 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112006 | Hamilton-TC1 | 2012 | 13 |
| K082600 | Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082) Class I | 2008 | 3 |
| K140939 | Hamilton-T1,Hamilton-C1 | 2015 | 2 |
| K103625 | Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device Class I | 2011 | 2 |
| K141595 | O-Two E700,O-Two E600,O-Two E500 Class I | 2015 | 1 |
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2016 | Class I | Z-2215-2016 | Device Design | Isolated episodes of leakage at the check valve were found |
| 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. |
| Aug 19, 2010 | Not classified | Z-0018-2011 | Error in labeling | Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume. |
| Oct 3, 2008 | Not classified | Z-0202-2009 | Software design | May experience an interruption of ventilation for approximately 5 seconds |
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
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 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 10; all are on the web page.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K112006 (Hamilton Medical AG, 2012) has gone furthest, with 13 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.
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?
Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062267: Oxylog 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062267
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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