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A vial adapter is a sterile, single-patient-use fitting that locks onto the stopper of a medication vial so that a syringe or an I.V. container can be connected to it without a needle. This page describes products and general use; it is not medical advice.
Who it is for: readers who need to tell the product classes apart. The sections below separate the two jobs these adapters do, give the regulatory identity of the class, and list the closure sizes stated in FDA and GUDID records.
What a vial adapter is
A vial adapter is a device fitted to a vial to let its contents be removed (or fluids added) without a needle. The global medical device nomenclature (GMDN) term is “Vial/bottle adaptor, non-hermetic” (term 60539), defined as a device intended to be fitted to a vial or bottle to enable the removal of its contents into a syringe for administration to a patient. One AccessGUDID record describes a 20 mm adapter that gives multiple needleless access to injection medication vials for transfer or withdrawal of fluids.
The same class goes by several names: vial adapter, vial adaptor, vial access device, needleless vial adapter, and “vial mate” (Vial-Mate is a Baxter brand name, so a “vial mate adapter” search usually means that brand or a similar product).
Regulatory identity. FDA files the records cited on this page under product code LHI, “Set, I.V. Fluid Transfer”, regulation 21 CFR 880.5440 (intravascular administration set), Class II (special controls). The product code is a quick way to find the FDA records for a given adapter. See FDA medical device classification and 510(k) premarket notification for how those records work.
How a vial adapter is built
The FDA 510(k) summary for the Medimop Swabable Vial Adapter (K072511, decision 13 December 2007) describes three parts: a double-lumen spike that penetrates the vial stopper, a body, and a luer-connection cap. It may include a hydrophobic medium on the body, and it is supplied sterile.
Types and what each is for
FDA and GUDID records describe two distinct jobs: giving a syringe needleless access to a vial, and joining a vial to an I.V. container.
| Type | Use as stated in the record | Key difference | Source |
|---|---|---|---|
| Swabable needleless vial adapter, 13 mm and 20 mm | Repeated needleless access to an injection medication vial, to withdraw or add drugs or solutions | Luer-connection cap for a syringe; optional hydrophobic medium on the body | FDA 510(k) K072511 |
| Vial-to-I.V.-container reconstitution adapter, 20 mm | Connects a standard 20 mm single-dose drug vial to an I.V. solution container | Keeps powdered drug and diluent in separate compartments until immediately before administration | FDA 510(k) K142600 (Baxter VIAL-MATE) |
| Needleless multi-access vial adapter, 20 mm | Transfer or withdrawal of fluids from injection medication vials | Labelled single-use and supplied sterile | AccessGUDID record, Q2 Vial Adapter 20 mm (Quest Medical) |
Vial adapter versus vented needle
A vial adapter is a needleless fitting; a vented needle is a needle. For the filtered vial access device comparison see What Is a Vented Needle?.
Closure sizes stated in FDA and GUDID records
| Product | Vial closure size stated | Source |
|---|---|---|
| Swabable Vial Adapter (Medimop) | 13 mm and 20 mm | FDA 510(k) K072511 |
| VIAL-MATE Adaptor / Reconstitution Device (Baxter) | 20 mm | FDA 510(k) K142600 |
| Q2 Vial Adapter 20 mm (Quest Medical) | 20 mm (in the product name) | AccessGUDID |
The closure diameter is the sizing axis in these records. For vial dimensions themselves, see vial sizes.
Labelling and handling
- Follow the manufacturer’s instructions for use for the specific adapter; the records above cover different products with different indications.
- The Q2 record lists the device as single-use and supplied sterile (no sterilization needed before use). The Medimop 510(k) states: “The adapter vial assembly is a single use device and should be disposed of after use.”
- The Baxter VIAL-MATE record does not state a single-use or reuse rule for the adapter; its “single dose” wording refers to the drug vial. Use the labelled instructions for that product.
- For the syringe an adapter connects to, see What Is a Syringe?. This page gives product information only, not clinical steps.
Common mistakes
- Treating “vial mate” as a generic name. It is one manufacturer’s brand of a 20 mm reconstitution adapter.
- Assuming every adapter is single-use or every adapter is reusable. The FDA and GUDID records label some as single-use and are silent for others; the label governs.
- Assuming 13 mm and 20 mm closures are interchangeable. The records name the closure size an adapter is specified for.
- Confusing a vial adapter, which gives needleless access, with a vented needle.
FAQ
What is the difference between a vial mate adapter and a vial adapter?
“Vial adapter” is the general class. Vial-Mate is Baxter’s brand of an adapter that connects a 20 mm single-dose drug vial to an I.V. solution container (FDA 510(k) K142600).
What is a needleless vial adapter?
It is an adapter that lets a syringe or I.V. container connect to a vial through its own spike and connector instead of a needle, as in the Medimop (K072511) and Q2 records.
Is a vial access device the same thing?
The term is used for the same class of product, for example the filtered vial access device compared in the vented needle guide.
Are vial adapters single-use?
The Q2 and Medimop records label them single-use. Others may differ, so follow the instructions for use of the product in hand.
Sources
- AccessGUDID (NLM), Q2 Vial Adapter 20 mm, Quest Medical: https://accessgudid.nlm.nih.gov/devices/20634624031603, checked 2026-10-31.
- FDA 510(k) K072511, Swabable Vial Adapter 13 mm and 20 mm, Medimop Medical Projects Ltd, decision 2007-12-13: https://fda.innolitics.com/device/K072511, checked 2026-10-31.
- FDA 510(k) K142600, VIAL-MATE Adaptor / Reconstitution Device, Baxter, decision 2014-11-19: https://fda.innolitics.com/device/K142600, checked 2026-10-31.
