# K981747: Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Sunscope Intl., Inc.
- Decided: Aug 20, 1998 after 94 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medex, Inc.’s Medex MX-960: named in the summary without a submission number
- (no number) Medex, Inc.’s Medex MX-860: named in the summary without a submission number
- (no number) Utah Medical Products Inc.’s Pressure Monitoring Kits: named in the summary without a submission number
- (no number) Ohmeda’s DTX Disposable Transducer Kits: named in the summary without a submission number

## Most influential descendants
- K070710: Accutrans Disposable Pressure Monitoring System (2007), 2 descendants of its own
- 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
The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases. Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency, The 40 cc/hr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery pump.

Source page: https://510kreport.com/device/K981747
Methodology: https://510kreport.com/methodology