# K102047: Lci Option for Innocor

- Pathway: 510(k) (Traditional)
- Applicant: Innovision A/S
- Decided: Nov 1, 2011 after 468 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051907: Innocor, Innovision A/S (2006) Summary page 2.
- K071911: Cardiopulmonary Exercise Testing Option to Innocor, Innovision A/S (2007) Summary page 2.
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500), Innovision A/S (2009) Summary page 2.
- K001174: Cosmed Quark, Cosmed Srl (2001) Summary page 2.
- K942211: VMAX229 Series Pulmonary/Metabolic Systems, Sensor Medics Corp. (1994) Summary page 2.

## Recalls of this device
- May 13, 2016 · Class II · Z-2769-2016: The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the ln

## Indications for use
The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCT), which is the cumulative expired volume required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (ERC). The specific parameters measured by the Innocor LCI Option include:

Source page: https://510kreport.com/device/K102047
Methodology: https://510kreport.com/methodology