Proguard Blood Collection Needle
510(k) K904295
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904295 | Date15 Oct 1990 | 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- Withdrawn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
- Full name
- Proguard(Tm) Blood Collection Needle
- 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, 1 Oct 2026
The Proguard Blood Collection Needle is a blood collection needle designed for safe and efficient venipuncture procedures. It is classified under product code FMI and is intended for use in phlebotomy to draw blood samples from patients. The device incorporates safety features to reduce the risk of needle-stick injuries, aligning with modern clinical practices for blood collection.
This device is supplied as a single-use, sterile disposable item and is regulated under FDA 510(k) clearance (K904295). It is intended for use in general hospital settings and must be handled in accordance with standard infection control protocols. No additional regulatory status beyond the stated FDA clearance is implied. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Safety-Ject, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Proguard Blood Collection Needle designed for?
The Proguard Blood Collection Needle is specifically designed for venipuncture procedures in phlebotomy, enabling safe and efficient blood sample collection from patients. Its safety features help reduce the risk of needle-stick injuries, which is critical in clinical settings where infection control is paramount. This makes it ideal for routine blood draws in general hospital environments.
Is the Proguard Blood Collection Needle reusable or single-use?
The Proguard Blood Collection Needle is intended for single-use only. As a sterile disposable item, it is engineered to maintain safety and hygiene standards during each procedure. Reusing this device would compromise sterility and increase infection risks, so adherence to single-use guidelines is essential.
How should the Proguard Blood Collection Needle be stored to maintain its integrity?
To preserve sterility and functionality, the Proguard Blood Collection Needle must be stored according to the manufacturer’s guidelines. This typically includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Proper storage ensures the device remains ready for safe use when needed.
What regulatory clearance does the Proguard Blood Collection Needle hold?
The Proguard Blood Collection Needle holds FDA 510(k) clearance under the reference number K904295. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a blood collection needle for venipuncture in general hospital settings. No additional regulatory status is implied beyond this clearance.
Are there different sizes or models available for the Proguard Blood Collection Needle?
The provided data does not specify multiple sizes or models for the Proguard Blood Collection Needle. However, as a standard venipuncture device, it is likely designed to accommodate common gauge requirements for blood collection. For precise sizing details, refer to the manufacturer’s product documentation or contact Safety-Ject, Inc.