# K151040: Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Biometrix, Ltd.
- Decided: Sep 4, 2015 after 137 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit, Hospira, Inc. (2006) Summary page 4.
- K070710: Accutrans Disposable Pressure Monitoring System, Biosensors International-USA (2007) Summary page 4.

## Indications for use
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring and monitoring of the blood and/or intra-abdominal pressure of the critically ill patients. The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravascular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.

Source page: https://510kreport.com/device/K151040
Methodology: https://510kreport.com/methodology