510(k) · Cleared
Recalled · 2005Babylog 8000 Plus
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 Jun 17, 1998 as substantially equivalent to K926292 (Drager, Inc., 1994) and 1 other predicate after a 223-day review. Its family tree reaches back 1 generation to 1991. 45 of the 154 devices in its family, counting itself, have a Class I recall. 151 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 1998
- Review
- 223 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902859 (1991). 2 ancestors in all. 151 later devices descend from it, 7 citing it directly. 45 of the 154 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- This deviceK974176 Babylog 8000 PlusDrager, Inc. · 1998
- Descendant · cites it directly · 134 of its ownK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 151 · See all- K992788Bear Cub 750 PSVBear Medical Systems, Inc. · 1999 · cites it directly134descendants
- K013642AVEABird Products Corp. · 2002 · 2 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| 0 (this device) | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | — |
| +1 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| +2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 1 |
| 2008 | 11 | 2 |
| 2009 | 6 | 1 |
| 2010 | 7 | 2 |
| 2011 | 13 | 7 |
| 2012 | 14 | 5 |
| 2013 | 11 | 5 |
| 2014 | 6 | 1 |
| 2015 | 9 | 1 |
| 2016 | 8 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 5 | 1 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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.
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? (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 |
|---|---|---|---|
| * | K926292 | Babylog 8000 Infant VentilatorSummary page 3…me controlled ventilation VIVE Variable Inspiratory, Variable Expiratory Flow Page 2 of 7 Drager Basis for the S&E - Decision 510(k) number K902859 K926292 under review Manufacturer Siemens Drager Dréager Classification Intensive Care Ventilator Intensive Care Ventilator inte… | 1994 |
| * | K902859 | Servo Ventilator 300Summary page 3…on), Volume controlled ventilation VIVE Variable Inspiratory, Variable Expiratory Flow Page 2 of 7 Drager Basis for the S&E - Decision 510(k) number K902859 K926292 under review Manufacturer Siemens Drager Dréager Classification Intensive Care Ventilator Intensive Care Ventila… | 1991 |
What descends from it? (151)
See all 1517 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992788 | Bear Cub 750 PSV | 1999 | 134 |
| K062710 | GE Datex-Ohmeda Engstrom Carestation | 2006 | 47 |
| K093886 | Engstrom Carestation, Engstrom Pro | 2010 | 21 |
| K093632 | Infinity Acute Care System Workstation Neonatal Care Class I | 2010 | 10 |
| K103211 | Avea Ventilator Class I | 2011 | 5 |
| K100011 | Fisher & Paykel Healthcare Bubble Cpap System | 2010 | 3 |
| K083050 | Evite XL | 2008 | 2 |
Has anything in its family been recalled? (45 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2005 | Not classified | Z-0515-06 | Other | Failure to generate an alarm when an unintended disconnection occurrs |
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.
- K103211Avea VentilatorCare Fusion · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K131502Seattle - PapSeattle Childrens Hospital · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
Nearest 12 of 45 shown.
Nearest 5 of 45; all are on the web page.
What does this lineage say?
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 Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 Ibs). The device provides the following ventilation modes: CMV Continuous Mandatory Ventilation Time-controlled, time-cycled, pressure-limited continuous flow ventilation. A/C Assist Control Ventilation Time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation that is synchronized…
Read the full statement (167 words)
The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 Ibs).
The device provides the following ventilation modes:
CMV Continuous Mandatory Ventilation
Time-controlled, time-cycled, pressure-limited continuous flow ventilation.
A/C Assist Control Ventilation
Time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation that is synchronized with each spontaneous patient breath.
SIMV Synchronized Intermittent Mandatory Ventilation
Time-controlled, volume triggered, flow cycled, pressure-limited continuous flow ventilation, synchronized with patient's spontaneous breathing at the set ventilation rate.
PSV Pressure Support Ventilation (available option)
Time-controlled, volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath.
CAP Ccontinuous Positive Airway Pressure
Spontaneous breathing with positive airway pressure
Ventilation mode extension:
VG Volume Guarantee (available option), Volume controlled ventilation. The ventilator controls inspiratory pressure in order to deliver the preset tidal volume. May be combined with A/C; SIMV and PSV.
VIVE Variable Inspiratory, Variable Expiratory Flow
Separate continuous flow during expiration in mandatory ventilation modes.
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/K974176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974176: Babylog 8000 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974176
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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