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Protectiv Safety Blood Collection Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001690

by Johnson & Johnson Medical, Inc.

Identifiers

510(k) Number
K001690 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Protectiv Safety Blood Collection Needle is a safety blood collection needle designed to reduce the risk of needlestick injuries during venipuncture procedures. It incorporates a protective sheath mechanism that retracts the needle into a safe position after use, helping to prevent accidental punctures. This device is classified under the FMI (Blood Collection Needles, Safety) product code and is intended for use in general hospital settings. Its design aligns with regulatory standards for blood collection systems, ensuring compliance with safety protocols in clinical environments.

This needle is supplied as a single-use, sterile device, intended for one-time use in blood collection procedures. It is regulated under FDA 510(k) clearance (K001690) and falls under the General Hospital advisory committee category. The device is not MRI-compatible and must be stored in accordance with manufacturer guidelines to maintain sterility. No additional regulatory approvals beyond the 510(k) clearance are referenced in the available data.

Frequently asked questions

What is the Protectiv Safety Blood Collection Needle designed for?

The Protectiv Safety Blood Collection Needle is specifically designed to reduce the risk of needlestick injuries during venipuncture procedures. Its key feature is an integrated protective sheath that automatically retracts the needle into a safe position after use, minimizing accidental punctures. This design aligns with clinical safety protocols for blood collection in general hospital settings.

Is the Protectiv Safety Blood Collection Needle single-use or reusable?

This device is intended for single-use only. It is supplied sterile and must not be reused to ensure patient safety and maintain sterility standards. Reusing a single-use medical device like this needle could compromise its safety features and increase infection risks.

How should the Protectiv Safety Blood Collection Needle be stored?

The needle must be stored according to the manufacturer’s guidelines to preserve sterility. This typically involves keeping it in its original, sealed packaging until use, away from direct sunlight, moisture, and extreme temperatures. Proper storage ensures the device remains safe and effective for its intended single-use application.

What regulatory clearance does the Protectiv Safety Blood Collection Needle hold?

The Protectiv Safety Blood Collection Needle holds FDA 510(k) clearance under the reference number K001690. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness in its intended use.

Can the Protectiv Safety Blood Collection Needle be used in MRI environments?

No, the Protectiv Safety Blood Collection Needle is not MRI-compatible. If used in or near MRI equipment, the device could interfere with imaging or pose safety risks due to metallic components. Always verify device compatibility with MRI procedures before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (K001690) — FDA 510 (k ..., PDF K001690 - Protectiv Safety Blood Collection Needle, Protectiv Safety Blood Collection Needle 510 (k) FDA Premarket ..., Johnson & Johnson Medical, Inc. FDA 510(k) Products (1990-2000), PROTECTIV™ Safety I.V. Catheters, Vascular Access, Peripheral l.V ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Johnson & Johnson Medical, Inc.

Sources (1)

  • FDA 510(k) K001690 24 fields · synced Oct 1, 2026