# K172458: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Nov 9, 2017 after 87 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 K885281 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K163172: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit, Smiths Medical Asd, Inc. (2017). Our reading of the summary gave K163712, FDA’s number for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (Shenzhen Wisonic Medical Technology Co., Ltd.), decided Jan 2, 2018, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar®…”. Summary page 7.

## Most influential descendants
- K221782: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (2023), 0 descendants of its own

## Indications for use
HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.

Source page: https://510kreport.com/device/K172458
Methodology: https://510kreport.com/methodology