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Filter Needle for Single Use

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233277

by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Identifiers

510(k) Number
K233277 FDA 510(k)
FDA Product Code
FPB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Filter Needle for Single Use is a sterile, disposable medical device designed as a Filter, Infusion Line (per FDA classification). It incorporates a filtration mechanism to remove particulate matter from intravenous fluids or medications, ensuring cleaner administration to patients. This device is intended for use in general hospital settings, where precise fluid delivery is critical to patient care.

Supplied as a single-use item, the Filter Needle is intended for one-time use only and must be discarded after use to maintain sterility and prevent contamination. It is classified as a Class 2 device under FDA regulations (21 CFR 880.5440) and has received FDA 510(k) clearance via the Traditional pathway. The device is not MRI-safe, and its compatibility with specific infusion systems should be verified by the manufacturer’s instructions. Storage conditions must adhere to the manufacturer’s guidelines to preserve sterility and functionality.

Frequently asked questions

What is the primary purpose of the Filter Needle for Single Use in clinical settings?

The Filter Needle for Single Use is designed to remove particulate matter from intravenous fluids or medications before administration, ensuring cleaner delivery to patients. This is particularly important in general hospital settings where precise fluid delivery is critical to patient care.

Is the Filter Needle for Single Use intended for reuse, or is it meant to be discarded after one use?

The Filter Needle for Single Use is explicitly intended for one-time use only and must be discarded after use to maintain sterility and prevent contamination. This design ensures patient safety by eliminating the risk of cross-contamination from reuse.

What storage conditions should be followed to keep the Filter Needle for Single Use functional and sterile?

The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. While specific storage instructions aren’t detailed here, adherence to standard sterile storage practices (e.g., sealed packaging, protected from moisture/dust) is critical, as implied by its single-use, sterile classification.

How do I confirm compatibility of this filter needle with my hospital’s infusion systems?

Compatibility with specific infusion systems should be verified by referring to the manufacturer’s instructions, as noted in the device description. While the Filter Needle is classified as a general infusion line filter, not all systems may be compatible, so always check the provided documentation.

What regulatory pathway was used for FDA clearance of this device, and what does that mean for its classification?

The Filter Needle for Single Use received FDA 510(k) clearance through the Traditional pathway and is classified as a Class 2 device under 21 CFR 880.5440. This classification indicates it carries moderate risk and requires compliance with special controls, but it does not require pre-market approval like higher-risk devices.

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: Hangzhou Qiantang Longyue Biotechnology Co., Ltd., Filter Needle for Single Use (K233277) — FDA 510(k) | Innolitics, K233277 FDA 510 (k) - Filter Needle for Single Use, Filter Needle for Single Use (K233277) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Sources (1)

  • FDA 510(k) K233277 24 fields · synced Oct 6, 2026