# K073593: I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016

- Pathway: 510(k) (Traditional)
- Applicant: Deltex Medical Limited
- Decided: Jan 29, 2009 after 405 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K851426 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052989: DP240 240 Hour Doppler Probe, Deltex Medical (2006) Summary page 2.
- K031706: Cardioq, Model 9051-7005, Deltex Medical (2003) Summary page 2.

## Cited in the summary but kept off the family tree
- K972798: Dynemo 3000, Sometec, Inc. (1998). Our reading of the summary gave K972798, FDA’s number for Dynemo 3000 (Sometec, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Arrow International, Inc. Hemosonic 100 Esophageal Probe”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K142932: Deltex Medical KDP72 Doppler Probe (2015), 0 descendants of its own

## Indications for use
The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I2is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Source page: https://510kreport.com/device/K073593
Methodology: https://510kreport.com/methodology