One Stick Y Extension Set and Volumeter
510(k) K060672
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060672 | Date31 Mar 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The One Stick Y Extension Set and Volumeter is a blood collection device classified under the FPA product code, designed for the collection and handling of blood specimens. It combines a Y-extension set with a volumeter to facilitate venous access, particularly for small or fragile veins, ensuring stable blood flow during phlebotomy. The device integrates a single-stick mechanism to minimize vein collapse, improving specimen integrity and patient comfort. Its construction enables efficient transfer of collected blood to a syringe or other collection container for subsequent laboratory testing.
This device is supplied as a sterile, single-use item intended for use in clinical settings such as hospitals and outpatient facilities. It adheres to FDA 510(k) clearance under the Traditional review pathway, with a Substantially Equivalent determination by the General Hospital (HO) Advisory Committee. The Y-extension set and volumeter are compatible with standard blood collection syringes and tubing systems, requiring no additional preparation beyond sterile handling. Storage should follow manufacturer guidelines to maintain sterility and functionality prior to use.
Questions
AI-generated answers, 1 Oct 2026
What is the One Stick Y Extension Set and Volumeter used for?
The One Stick Y Extension Set and Volumeter is designed specifically for blood collection in clinical settings. It integrates a Y-extension set with a volumeter to maintain stable blood flow during phlebotomy, particularly useful for patients with small or fragile veins. This design minimizes vein collapse, ensuring specimen integrity and improving patient comfort while transferring blood to a syringe or other collection container for laboratory testing.
Is the One Stick Y Extension Set and Volumeter sterile and single-use?
Yes, the One Stick Y Extension Set and Volumeter is supplied as a sterile, single-use device. This ensures safety and reliability for clinical use, preventing cross-contamination and maintaining compliance with sterile handling protocols in hospitals and outpatient facilities.
How does the Y-extension set and volumeter improve blood collection?
The Y-extension set allows for efficient blood flow management, while the integrated volumeter provides precise measurement of collected blood. Together, they create a stable venous access system that reduces the risk of vein collapse, which is particularly beneficial for patients with delicate veins. This setup also simplifies the transfer of blood to a syringe or container, ensuring smoother and more accurate specimen collection.
What compatibility does the One Stick Y Extension Set and Volumeter have with other systems?
The device is designed to be compatible with standard blood collection syringes and tubing systems. No additional preparation is required beyond adhering to sterile handling procedures. This compatibility ensures seamless integration into existing phlebotomy workflows in clinical environments.
How should the One Stick Y Extension Set and Volumeter be stored before use?
To maintain sterility and functionality, the device should be stored according to the manufacturer’s guidelines. Proper storage conditions help preserve the integrity of the single-use item, ensuring it remains ready for use in clinical settings like hospitals and outpatient facilities without compromising performance or safety.