510(k) Report

510(k) · Cleared

Cleared

Trucath.IP

K023368510(k) TraditionalCleared Oct 28, 200220-day reviewClass II21 CFR 866.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aortech Critical Care, Ltd. · DFG Lambda, Rhodamine, Antigen, Antiserum, Control

Cleared on Oct 28, 2002 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 28, 2002
Review
20 days
Class
Class II
Product code
DFG
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K023368Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DFG devices

DFG Lambda, Rhodamine, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DFG

FDA has decided no DFG device since 2007.

Median 510(k) review, days · DFG

Too few DFG 510(k)s in any year since 2007 to give a median.

Recalls per year · DFG

No recall names DFG since 2007.

Adverse event reports per year · DFG

No MAUDE report names DFG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The TruCATH.IP ‘S intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring., cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood. In addition the TCH 5100 product provides an additional infusion lumen that allows for continuous infusion.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K023368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023368: Trucath.IP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023368

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026