# K123292: T3

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Jun 11, 2013 after 232 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 54 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033570: Medcomp T-3, Medcomp (2004) Summary page 1.
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter, C.R. Bard, Inc. (2009) Summary page 1.
- K102605: Mahurkar Triple Lumen Dialysis Catheter, Covidien, LLC, Formerly Registered AS Tyco Healthca (2010). Our OCR of the scanned summary read K102635, FDA’s number for Apolonia Laser Implant System (Csm Implant Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MAHURKART™ Triple Lumen Catheter”.
- K121848: Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii 40CM and 55CM, Medical Components, Inc. (2012) Summary page 1.
- K091953: Pro-Picc, Medcomp (2009). Our OCR of the scanned summary read K091933, FDA’s number for Electro-Acupuncture: Aculife/Model Idoc-01 (Inno-Health Technology, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pro-Picc CT”.
- K020465: Medcomp Ash Split-Cath II, Medcomp (2002). Our OCR of the scanned summary read K020463, FDA’s number for Depilase Yag Lase Plus Laser System (Depilase Group, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ash Split Cath II”.
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6, Medical Components, Inc. (1999). Our OCR of the scanned summary read K981123, FDA’s number for UREA (Trace Scientific, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Silicone Tesio”.
- K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen, Medcomp (2009) Summary page 1.
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached), Medcomp (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K072309: Microlux/Blu, Addent, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K232945: Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (2023), 0 descendants of its own

## Indications for use
The Medcomp® T3™ catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K123292
Methodology: https://510kreport.com/methodology