BD Single Use Hypodermic Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172670 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 BD Single Use Hypodermic Syringe is a three-piece manual device classified as a hypodermic syringe (product code FMF) under FDA nomenclature. It consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod, designed for single-use fluid aspiration or injection in clinical settings.
This device is intended for use by healthcare professionals in general hospital environments and is supplied sterile for one-time use. It requires no special storage conditions beyond protection from contamination and is not MRI-compatible. The device holds an FDA 510(k) clearance (K172670) under the Traditional pathway, with a decision date of October 23, 2018.
Frequently asked questions
What clinical settings is this syringe designed for and who typically uses it?
The BD Single Use Hypodermic Syringe is designed for use in general hospital environments. It is intended for healthcare professionals, such as nurses, doctors, or pharmacists, who administer injections or draw fluids in clinical settings. Its single-use, sterile design ensures safe and hygienic use in these controlled environments.
Is this syringe reusable or meant for single-use, and how should it be stored?
This syringe is explicitly designed for single-use only, as indicated by its name and sterile packaging. Storage requires only basic precautions—keep it protected from contamination, dust, or physical damage. No special environmental conditions (like refrigeration or humidity control) are needed.
What regulatory pathway was followed for FDA clearance, and what does that mean for its use?
The BD Single Use Hypodermic Syringe received FDA clearance through the Traditional 510(k) pathway, specifically under the General Hospital advisory committee (HO). This means the device was deemed *substantially equivalent* to a legally marketed predecessor, confirming its safety and performance for its intended use in clinical fluid aspiration or injection. The clearance (K172670) was granted on October 23, 2018.
Can this syringe be used in MRI environments, and what are its key material components?
This syringe is not MRI-compatible, so it should not be used in magnetic resonance imaging environments. The device consists of a plastic barrel (likely polypropylene or similar), a synthetic rubber stopper, and a plastic plunger rod, all designed for single-use medical procedures.
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: BD® Hypodermic Needle and Syringe Solutions | BD, BD SINGLE USE, HYPODERMIC SYRINGE (K110771) — FDA 510(k) | Innolitics, BD (company) - Wikipedia, K110771 FDA 510 (k) - BD SINGLE USE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172670 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K172670 24 fields · synced Oct 6, 2026