# K070710: Accutrans Disposable Pressure Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Biosensors International-USA
- Decided: Apr 19, 2007 after 36 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: 1 generation back to K841788 (1985). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981747: Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx, Sunscope Intl., Inc. (1998) Summary page 1.
- K841788: Utah Disposable Pressure Transducer, Utah Medical Products, Inc. (1985) Summary page 1.

## Most influential descendants
- 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 (2015), 0 descendants of its own
- K102033: Combitrans Monitoring Sets and Accessories (2011), 0 descendants of its own

## Indications for use
Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, Into electrical signals which can be displayed using separate monitoring equipment The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer. : Accutrans Disposable Pressure Transducer,The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with 30cc/hrl flush devices are designed exclusively for use with a Infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is Intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream.'Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting. Accu Trans Pressure Monitoring Kfs and Accu Trans Disposable Transducer are Indirectly in contact with the blood path and hence, are supplied sterile and Is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient. suitable cleaning instructions should be followed to minimize cross contaminatIon between patient and health worker.

Source page: https://510kreport.com/device/K070710
Methodology: https://510kreport.com/methodology