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Insulin Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193273

by Promisemed Hangzhou Meditech Co., Ltd.

Identifiers

510(k) Number
K193273 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Insulin Syringe is a disposable medical device classified under the nomenclature for insulin administration, designed for subcutaneous or intramuscular injection of insulin. It features a calibrated barrel, plunger, and needle assembly to deliver precise insulin doses. Constructed for single-use, it ensures aseptic administration to patients requiring insulin therapy. This device is intended for use in general hospital settings as part of diabetes management protocols.

Supplied sterile and intended for single-use only, the Insulin Syringe is regulated under FDA 510(k) clearance (K193273) as substantially equivalent to predicate devices. Available in standard sizes and configurations, it must be stored in a clean, dry environment to maintain sterility. The device adheres to product code FMF and is manufactured by Promisemed Hangzhou Meditech Co., Ltd., with no third-party involvement in its regulatory submission. Compliance with FDA requirements ensures its suitability for clinical use in insulin-dependent patients.

Frequently asked questions

What is the Promisemed Insulin Syringe designed for?

The Promisemed Insulin Syringe is a disposable medical device specifically designed for subcutaneous or intramuscular administration of insulin. Its calibrated barrel, plunger, and needle assembly allow for accurate dosing, making it ideal for patients requiring insulin therapy as part of diabetes management protocols in general hospital settings.

Is the Promisemed Insulin Syringe sterile and single-use?

Yes, the Promisemed Insulin Syringe is supplied sterile and intended for single-use only. This design ensures aseptic administration, reducing the risk of contamination and infection for patients undergoing insulin therapy.

How should the Promisemed Insulin Syringe be stored?

To maintain sterility, the Promisemed Insulin Syringe must be stored in a clean, dry environment. Proper storage conditions are critical to preserving the device’s integrity and ensuring safe clinical use.

What regulatory clearance does the Promisemed Insulin Syringe hold?

The Promisemed Insulin Syringe holds FDA 510(k) clearance under the reference number K193273. It is classified as substantially equivalent to predicate devices and adheres to FDA requirements for clinical use in insulin-dependent patients.

Are there different sizes or models available for the Promisemed Insulin Syringe?

The Promisemed Insulin Syringe is available in standard sizes and configurations, though specific variations (e.g., needle gauge or barrel length) are not detailed in the provided data. For precise sizing options, refer to the manufacturer’s product catalog or technical specifications.

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: Insulin Pen Needles Manufacturer | Promisemed, Promisemed, Insulin Pen Needles - Promisemed Hangzhou Meditech Co., Ltd., Promisemed Hangzhou Meditech Co.,Ltd - insulin pen needle, safety ..., Sterile Insulin Injection Syringe — Promisemed Hangzhou Meditech Co ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.

Sources (1)

  • FDA 510(k) K193273 24 fields · synced Oct 6, 2026