# K981745: Biotrans Reusable Sensor Base Model Number BT Xxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Sunscope Intl., Inc.
- Decided: Jul 17, 1998 after 60 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: 2 generations back to K951129 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951129: Novatrans II, Medex, Inc. (1995) Summary page 1.
- K961404: MX960 Reusable Pressure Transducer, Medex, Inc. (1996) Summary page 1.
- K841788: Utah Disposable Pressure Transducer, Utah Medical Products, Inc. (1985) Summary page 1.

## Indications for use
The BSI BIOTRANS Sensor Base is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can be displayed using separate monitoring equipment.

Source page: https://510kreport.com/device/K981745
Methodology: https://510kreport.com/methodology