# K102968: Infinity Cnap Smartpod

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 18, 2011 after 135 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082599: Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT, Cnsystem Medizintechnik AG (2008) Summary page 1.

## Most influential descendants
- K131085: Central Venous Pressure System - Mespere Venus 1000 (2013), 1 descendant of its own
- K151776: Central Venous Pressure System (2015), 0 descendants of its own

## Indications for use
The Infinity CNAP SmartPod is indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults by medical professionals. The Infinity CNAP SmartPod is intended for use with the Infinity Modular patient monitors of the Delta series (Delta, Delta XL, Kappa, 507000, 508000, SC9000XL). Derived arterial values and pressure waveforms are displayed when a pod is connected to one of the previously identified patient monitors. The Infinity ONAP SmartPod supports the following parameters: Continuous and oscillometric blood pressure Pulse rate CNAP-S (systolic pressure) CNAP-D (diastolic pressure) CNAP-M (mean pressure) The Infinity ONAP Smartpod performance may be affected in situations where the flow of blood to the finger is severely inhibited or in the presence of pathologically increased stiffness of the finger arteries. Included as examples: * Cases of severe shock or hypothermia * Severe arteriosclerosis of the upper extremities * Primary or secondary Raynaud's syndrome and related diseases * Endarteritis obliterans * Collagenosis affecting peripheral arteries The Infinity CNAP SmartPod is not intended for use on patients with vascular implants at the site of measurement. The Infinity CNAP SmartPod is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K102968
Methodology: https://510kreport.com/methodology