# K942377: Transtar Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Aug 16, 1994 after 90 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974241: Scimed Informer Pressure Wire System (1998), 0 descendants of its own

## Recalls of this device
- Sep 24, 2024 · Class II · Z-0184-2025: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar 
- Sep 24, 2024 · Class II · Z-0185-2025: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar 
- Sep 24, 2024 · Class II · Z-0186-2025: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar 

Source page: https://510kreport.com/device/K942377
Methodology: https://510kreport.com/methodology