# K190561: NICU V'02

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Nordic Aps
- Decided: Sep 4, 2020 after 549 days
- Product code: BZL (Computer, Oxygen-Uptake)
- Device class: 2
- Regulation: 21 CFR 868.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070858: Express Series, Medical Graphics Corp. (2007) Summary page 4.
- K051907: Innocor, Innovision A/S (2006) Summary page 4.
- K071911: Cardiopulmonary Exercise Testing Option to Innocor, Innovision A/S (2007) Summary page 4.
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500), Innovision A/S (2009) Summary page 4.
- K021490: Reevue Indirect Calorimeter, Model#8100, Korr Medical Technologies, Inc. (2003) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K190561
Methodology: https://510kreport.com/methodology