SecuMax Blood Collection System
by Tiger Meditech Incorporated 510(k)
Active
510(k) K032141
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032141 | Date28 Jan 2004 | 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- Withdrawn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
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SecuMax Blood Collection System is a multi-sample blood collection device designed for phlebotomy procedures in general hospital settings. It integrates a sterile Luer holder and hypodermic needle with a Luer adapter to facilitate efficient and safe blood sampling into evacuated tubes or similar containers.
This system is intended for single-use in clinical environments and has received FDA 510(k) clearance under the product code FMI. Supplied sterile and packaged for direct patient use, it adheres to traditional review standards and is classified under the General Hospital advisory committee. No additional regulatory markings beyond the stated clearance are provided in the specifications.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical settings is the SecuMax Blood Collection System intended for use in?
The SecuMax Blood Collection System is specifically designed for general hospital settings where phlebotomy procedures are performed. Its design ensures safe and efficient blood sampling for multiple tubes, making it suitable for routine clinical blood draws in inpatient or outpatient environments where evacuated tubes or similar containers are used.
Is the SecuMax Blood Collection System reusable, or is it meant for single-use only?
The SecuMax Blood Collection System is explicitly intended for single-use only in clinical environments. This design choice aligns with best practices for infection control and patient safety, ensuring each device is sterile and dedicated to one procedure.
How is the SecuMax Blood Collection System packaged, and is it sterile upon arrival?
Yes, the SecuMax Blood Collection System is supplied sterile and packaged for direct patient use. The packaging ensures the sterile integrity of the Luer holder, hypodermic needle, and Luer adapter until the moment of use, eliminating the need for additional sterilization steps.
What regulatory pathway was followed for FDA clearance of the SecuMax Blood Collection System?
The SecuMax Blood Collection System received FDA 510(k) clearance under the product code FMI, classified under the General Hospital advisory committee (HO). The clearance was granted through a traditional review process, with the device deemed substantially equivalent to a predicate device, and the submission was filed in 2003.