# K163376: Mikro-Cath Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Millar, Inc.
- Decided: Mar 10, 2017 after 99 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831506 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093111: Mikro-Cath, Model 825-0101, Millar Instruments, Inc. (2010) Summary page 5.
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit, Hospira, Inc. (2006) Summary page 5.
- K830909: Mikro-Tip Cath. Pressure Transducer, Millar Instruments, Inc. (1983) Summary page 5.

## Indications for use
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short term limited body contact (<24 hours).

Source page: https://510kreport.com/device/K163376
Methodology: https://510kreport.com/methodology