Blood Collecting Needle
510(k) K855248
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855248 | Date26 Feb 1986 | 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- Withdrawn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
- 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 Blood Collecting Needle is a sterile, single-use medical device classified under the FDA product code FMI. Designed for venipuncture, it facilitates the collection of blood samples for diagnostic testing by piercing the skin and entering a vein. Its primary function is to ensure accurate and efficient blood withdrawal while minimizing patient discomfort and infection risk. The device adheres to regulatory standards for general hospital use and is intended for clinical laboratory settings.
This needle is supplied as a disposable item, ensuring sterility and reducing cross-contamination risks. It is intended for single-use only and must be discarded after use in accordance with infection control protocols. The device is cleared under the FDA’s 510(k) pathway (K855248) as substantially equivalent to a predicate device, with no explicit MRI safety or reusable specifications noted. Storage should follow manufacturer guidelines to maintain sterility and integrity prior to use.
Other devices from Churchill Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Churchill Blood Collecting Needle used for?
The Churchill Blood Collecting Needle is designed specifically for venipuncture, enabling healthcare professionals to collect blood samples efficiently and accurately for diagnostic testing. Its primary purpose is to pierce the skin and enter a vein with precision, reducing patient discomfort and lowering the risk of infection during the procedure. This makes it ideal for clinical laboratory settings where reliable blood sample collection is critical.
Is the Churchill Blood Collecting Needle reusable or single-use?
The Churchill Blood Collecting Needle is intended for single-use only. It is supplied sterile to prevent cross-contamination and must be discarded immediately after use to comply with infection control protocols. Reusing this device could compromise sterility and patient safety, so adherence to single-use guidelines is essential.
How should the Churchill Blood Collecting Needle be stored?
To maintain sterility and integrity before use, the Churchill Blood Collecting Needle should be stored according to the manufacturer’s guidelines. This typically involves keeping it in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for safe clinical use.
What regulatory pathway does the Churchill Blood Collecting Needle follow?
The Churchill Blood Collecting Needle is cleared under the FDA’s 510(k) pathway (K855248) as substantially equivalent to a predicate device. This means it meets regulatory standards for general hospital use and has been evaluated for safety and effectiveness in venipuncture procedures. The clearance does not specify MRI safety or reusable applications, reinforcing its intended single-use purpose.
What product code classification does the Churchill Blood Collecting Needle hold?
The Churchill Blood Collecting Needle is classified under FDA product code FMI, which categorizes it as a blood collection device for venipuncture. This classification aligns with its intended use in clinical settings for diagnostic blood sampling, ensuring it adheres to relevant regulatory and safety standards.