HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
by Smiths Medical Asd, Inc. 510(k)
Active
510(k) K172458
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172458 | Date9 Nov 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2850
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HemoDraw Plus Closed Blood Sampling System is a closed-system device designed for arterial or central venous pressure monitoring and blood sampling. It combines a sampling system with extravascular blood-pressure transducers (LogiCal or Transtar) to facilitate safe, contamination-free blood collection while maintaining hemodynamic monitoring continuity. This system is classified as a Class II medical device under FDA regulations, ensuring compliance with stringent performance and safety standards for cardiovascular applications.
The device is intended for use in adult clinical settings, providing a sterile, single-use solution for blood sampling from monitoring lines. It is supplied as a complete kit, including the sampling system and transducer, and must be stored under controlled conditions to preserve sterility. The HemoDraw Plus system has received FDA 510(k) clearance under the Traditional pathway, affirming its substantial equivalence to a predicate device. No MRI safety considerations are specified, and the system is not reusable.
Other devices from Smiths Medical Asd, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the HemoDraw Plus Closed Blood Sampling System used for?
The HemoDraw Plus Closed Blood Sampling System is designed for arterial or central venous pressure monitoring and blood sampling in adult clinical settings. It provides a sterile, closed-system solution to collect blood samples while maintaining continuous hemodynamic monitoring, reducing the risk of contamination.
How is the HemoDraw Plus system supplied, and what does a kit include?
The HemoDraw Plus system is supplied as a complete, single-use kit. Each kit includes the closed blood sampling system paired with either a LogiCal or Transtar extravascular blood-pressure transducer. This ensures compatibility for safe blood collection and pressure monitoring without the need for additional components.
Is the HemoDraw Plus system sterile, and how should it be stored?
Yes, the HemoDraw Plus system is sterile and intended for single-use only. To maintain sterility, it must be stored under controlled conditions as specified by the manufacturer. Improper storage could compromise the device’s integrity and safety.
Can the HemoDraw Plus system be reused, and what are its regulatory approvals?
No, the HemoDraw Plus system is not reusable. It is classified as a Class II medical device and has received FDA 510(k) clearance under the Traditional pathway, affirming its substantial equivalence to a predicate device for cardiovascular applications.
Are there any MRI safety considerations for the HemoDraw Plus system?
The device data does not specify any MRI safety considerations for the HemoDraw Plus system. Clinicians should verify compatibility with their MRI equipment and protocols before use in an MRI environment.