Promisemed Sterile Hypodermic Syringes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211242 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 Promisemed Sterile Hypodermic Syringes are sterile, disposable hypodermic syringes designed for single-use administration of medications, fluids, or vaccines. These devices fall under the classification of hypodermic needles and syringes (FDA Product Code: FMF) and are intended for use in general hospital settings. They are manufactured to ensure precision in dosage delivery while maintaining aseptic conditions. The syringes are engineered for compatibility with standard intravenous and subcutaneous injection techniques.
These syringes are supplied sterile and intended for single-use only, adhering to standard medical practice to prevent contamination and ensure patient safety. They are regulated under FDA 510(k) clearance (K211242) and EU MDR compliance, confirming their adherence to safety and performance standards. The devices are manufactured by Promisemed Hangzhou Meditech Co., Ltd., and are classified as FDA Class II medical devices. No additional sterilization or reprocessing is required prior to use, and they must be stored in a clean, dry environment as per manufacturer guidelines.
Frequently asked questions
Are these syringes reusable or intended for single-use only, and why does that matter for patient safety?
These syringes are explicitly designed for single-use only, as stated in the manufacturer’s instructions. Reusing hypodermic syringes poses significant risks, including cross-contamination, infection transmission (e.g., bloodborne pathogens), and compromised sterility. Single-use adherence aligns with standard medical practice to ensure aseptic conditions and patient safety, eliminating the need for additional sterilization or reprocessing.
What types of medical procedures or settings are these syringes primarily intended for?
The syringes are classified under FDA Product Code FMF (hypodermic needles and syringes) and are intended for general hospital settings. They are engineered for compatibility with standard intravenous and subcutaneous injection techniques, making them suitable for administering medications, fluids, or vaccines in clinical environments where precision dosing and sterility are critical.
How should these syringes be stored to maintain their sterility and usability?
The manufacturer recommends storing these syringes in a clean, dry environment to preserve sterility and integrity. Since they are pre-sterilized and intended for single-use, exposure to moisture, dust, or extreme temperatures could compromise their condition. Proper storage ensures they remain ready for immediate use without requiring additional sterilization procedures.
What regulatory pathways have these syringes undergone, and what does that mean for their safety and compliance?
These syringes have undergone FDA 510(k) clearance (K211242) and comply with EU MDR (Medical Device Regulation) standards. The FDA’s 510(k) clearance confirms they are *substantially equivalent* to legally marketed devices, while EU MDR compliance ensures they meet stringent safety, performance, and traceability requirements. Both pathways validate their adherence to global medical device regulations.
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: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic ..., Promisemed, Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic ..., Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211242 | Class II | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
Sources (2)
- FDA 510(k) K211242 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026