# K051907: Innocor

- Pathway: 510(k) (Traditional)
- Applicant: Innovision A/S
- Decided: Mar 2, 2006 after 231 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 27 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872529: Thermodilution Cardiac Output Computer, Mod. Com-2, American Edwards Laboratories (1987) Summary page 1.
- K830892: Thermodilution Cardiac Output Computer-, American Edwards Laboratories (1983) Summary page 1.
- K970763: Modular Telemetry System (MTS) Option for the Mde Escort II Monitor, Medical Data Electronics (1997) Summary page 1.
- K982776: 9303 Neonatal/Adult Vital Signs Monitor, Cas Medical Systems, Inc. (1998) Summary page 1.
- K021138: Sleepscreen/Apnoescreen Cardio, Erich Jaeger GmbH (2003) Summary page 1.
- K032363: Zoll M Series Nibp Option, Zoll Medical Corp (2003) Summary page 1.
- K051703: Clever TD-3018A Blood Pressure Monitor, Taidoc Technology Corporation (2005). Cleared while this submission was under review Summary page 1.
- (no number) Direct Fick Method preamendment calculation method: named in the summary without a submission number

## Most influential descendants
- K071911: Cardiopulmonary Exercise Testing Option to Innocor (2007), 3 descendants of its own
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500) (2009), 2 descendants of its own
- K190561: NICU V'02 (2020), 0 descendants of its own
- K102047: Lci Option for Innocor (2011), 0 descendants of its own

## Indications for use
Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respiration> and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation <95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to C0 As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: * Cardiac Output * Arterial Oxygen Saturation * Heart Rate * Stroke Volume Lung Volume * Cardiac Index * Stroke Index * Blood Pressures (Systolic, Diastolic, Mean Arterial) * Systemic Vascular Resistance Systemic Vascular Resistance Index

Source page: https://510kreport.com/device/K051907
Methodology: https://510kreport.com/methodology