510(k) · Cleared
ClearedNICU V'02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmed Nordic Aps · BZL Computer, Oxygen-Uptake
Cleared on Sep 4, 2020 as substantially equivalent to K070858 (Medical Graphics Corp., 2007) and 4 other predicates after a 549-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Sep 4, 2020
- Review
- 549 days
- Class
- Class II
- Product code
- BZL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962603 (1997). 45 ancestors in all, the oldest K830892 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK051907 InnocorInnovision A/S · 2006
- 2 generations backK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- 1 generation backK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- This deviceK190561 NICU V'02Cosmed Nordic Aps · 2020
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 3 generations backK051907 InnocorInnovision A/S · 2006
- 2 generations backK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- 1 generation backK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- This deviceK190561 NICU V'02Cosmed Nordic Aps · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −3 | K051907 | Innocor | Innovision A/S | 2006 | — |
| −2 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| −1 | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including… | Innovision A/S | 2009 | — |
| 0 (this device) | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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.
Planning a device in BZL? 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 BZL device
- #1 K200076 Breezing Medscore 0.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K070858 | Express SeriesSummary page 4…MedGraphics Express Series Manufacturer: Medical Graphics Corporation (Now MGC Diagnostics) 510(k) number: K070858 Secondary Predicate No. 1 Device: Innocor (incl. Cardiopulmonary Exercise Testing Option)… | 2007 |
| * | K051907 | InnocorSummary page 4…Innocor (incl. Cardiopulmonary Exercise Testing Option) Manufacturer: Innovision ApS (same as applicant) 510(k) number(s) K051907, K071911 and K083879 Secondary Predicate No. 2 Device: REEVUE Indirect Calorimeter (Model: 810… | 2006 |
| * | K071911 | Cardiopulmonary Exercise Testing Option to InnocorSummary page 4…cor (incl. Cardiopulmonary Exercise Testing Option) Manufacturer: Innovision ApS (same as applicant) 510(k) number(s) K051907, K071911 and K083879 Secondary Predicate No. 2 Device: REEVUE Indirect Calorimeter (Model: 8100)… | 2007 |
| * | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Summary page 4…ardiopulmonary Exercise Testing Option) Manufacturer: Innovision ApS (same as applicant) 510(k) number(s) K051907, K071911 and K083879 Secondary Predicate No. 2 Device: REEVUE Indirect Calorimeter (Model: 8100) Manufactu… | 2009 |
| * | K021490 | Reevue Indirect Calorimeter, Model#8100Summary page 5…= K190561 Page 2 of 8 510(k) number: K021490 Reference method Device: Douglas Bag (Gold Standard) 1 Manufacturer:… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 45 ancestors have a recall of any class.
- 1 other device also cites its predicate K070858.
How does its category compare?
All BZL devicesBZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BZL
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · BZL
Too few BZL 510(k)s in any year since 2007 to give a median.
Recalls per year · BZL
No recall names BZL since 2007.
Adverse event reports per year · BZL
1in 2023
MAUDE reports naming product code BZL, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is indicated for use in mechanically ventilated neonate, infant and pediatric patients where the precise and direct measurement of oxygen uptake (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization. Applications The NICU V'O2 device is a…
Read the full statement (136 words)
The device is indicated for use in mechanically ventilated neonate, infant and pediatric patients where the precise and direct measurement of oxygen uptake (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.
Applications
The NICU V'O2 device is a non-invasive indirect calorimeter for use in clinical and/or research applications for determination of metabolic parameters by measuring expired gas composition (oxygen and carbon dioxide) and volume.
The device is intended for use by qualified medical staff in professional healthcare facilities.
Population studied
Clinical testing has been performed in intubated, mechanically ventilated neonates and infants with ability to tolerate brief interruptions in the ventilatory circuit when connecting and disconnecting the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190561: NICU V'02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190561
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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