510(k) · Cleared
ClearedBabylog VN800, Babylog VN600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · CBK Ventilator, Continuous, Facility Use
Cleared on May 16, 2023 as substantially equivalent to K093632 (Drager Medical AG & Co. Kgaa, 2010) after a 295-day review. Its family tree reaches back 9 generations to 1991. 4 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- May 16, 2023
- Review
- 295 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K902859 (1991). 32 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet. 4 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- 1 generation backK093632 Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · Recalled (Class I)
- This deviceK222207 Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa · 2023
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK961687 EVITA 4Drager, Inc. · 1996
- 7 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 6 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 4 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- 1 generation backK093632 Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · Recalled (Class I)
- This deviceK222207 Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa · 2023
Class I recalls in this family
- K093632 Infinity Acute Care System Workstation Neonatal…direct predicate · 2010
- K001646 Puritan-Bennett 840 Ventilator System with…4 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…4 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…5 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −7 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −6 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −4 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −3 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −2 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| −1 | K093632 | Infinity Acute Care System Workstation Neonatal Care | Drager Medical AG & Co. Kgaa | 2010 | Class I |
| 0 (this device) | K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 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.
4 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? (1)
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 |
|---|---|---|---|
| * | K093632 | Infinity Acute Care System Workstation Neonatal CareSummary page 4…Product Code: CBK Class: II Predicate Device: Infinity Acute Care System Workstation Neonatal Care, K093632 Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, Babylog VN800 / Babylog V… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 12 of the 32 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K093632.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Babylog intensive care Ventilator (Babylog VN800 / Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).
This device provides mandatory pressure-controlled ventilation modes, ventilation modes for supporting spontaneous breathing, and ventilation monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222207 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222207: Babylog VN800, Babylog VN600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222207
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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