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A T-connector IV extension set is a short length of sterile tubing with a T-shaped fitting at one end. The T carries a side access point, an injection port or a needle-free valve. This page explains the parts, how FDA classifies the device, and how to read the numbers on a real label or device record.
This page describes products and general use; it is not medical advice.
What a T-connector extension set is
A T-connector extension set is an intravascular administration set that adds a short, clamped length of tubing and an access port between a fluid source or syringe and a vascular access device. In US regulation, the intravascular administration set is defined in 21 CFR 880.5440(a) as a device used to administer fluids from a container to a patient’s vascular system, and the definition lists tubing, a flow regulator and connectors between parts of the set among the components it may include. Both FDA records cited on this page place T-connector extension sets under that regulation, as Class II (special controls), with FDA product code FPA (FDA 510(k) K112799; NLM AccessGUDID, checked 2026-10-30).
Who uses it: clinical staff who set up infusions and syringe injections, supply and materials-management staff who stock them, and students learning infusion equipment.
Parts and how it is built
The FDA 510(k) summary for the Benlan MED-RX Extension Set with T-Connector (K112799, decision 23 December 2011) gives a complete parts list for one real design:
- Proximal end: a T-connector with an injection port and an integral rotating male luer lock.
- Tubing: PVC, 0.040 in inner diameter and 0.095 in outer diameter.
- Clamp: a slide clamp on the tubing.
- Distal end: a female luer lock.
- Caps: a protective cap on each luer fitting.
Luer fittings are the connectors used on syringes and tubing; see syringe tip types for how luer lock differs from luer slip.
Types and variants
Two published records show the main variation: what sits on the side of the T, and which luer type the set uses.
| Example | Side access on the T | Luer fittings | Other listed features | Source |
|---|---|---|---|---|
| BD Alaris SmartSite, catalog 20051E | Needle-free valve | Slip luer (per device description) | 6 in (15 cm); priming volume 0.2 mL | NLM AccessGUDID |
| Benlan MED-RX (K112799) | Injection port | Rotating male luer lock proximal; female luer lock distal | Slide clamp; 4 in or 38 in; PVC tubing | FDA 510(k) summary |
Lengths and specifications on real labels
Only a few values are standardized by the records themselves, so read them from the label or device record rather than assuming:
- Length: 15 cm (6 in) for the 20051E; 4 in or 38 in for the MED-RX, which the summary describes as identical except for tubing length.
- Priming volume: 0.2 mL listed for the 20051E. This is the fluid the set holds before it reaches the patient end.
- Tubing size: 0.040 in ID and 0.095 in OD for the MED-RX.
- Sterile and single use: both records describe the set as supplied sterile and single use. AccessGUDID adds that no sterilization is needed before use.
- Latex: the 20051E record states it is not made with natural rubber latex.
- MRI: the 20051E record states its labeling does not contain MRI safety information. That is a statement about the labeling, not a safety finding.
How to choose: read the label and indication
The records show a few things that appear on a set’s labeling:
- Indication. The K112799 indication is “administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.” An indication can be limited to a patient population, so check the one on the set’s own labeling.
- Connector match. The set’s fittings must be compatible with what it connects to; the 510(k) summary describes standard luer fittings.
- Side access type. A needle-free valve and a plain injection port are different designs, as the table shows; the instructions for use for the specific product govern how each is accessed.
- Latex and MRI statements. Where a record carries them, they come from the labeling.
Safe use and handling basics
The records support only general points: these sets are supplied sterile, are single use, and the K112799 set ships with protective caps on its luer fittings. Follow the manufacturer’s instructions for use and facility policy for everything else, including set-up, priming, access and change intervals. This page does not give procedure steps.
Common mistakes
- Assuming two T-connector sets are interchangeable. The examples above differ in side access, luer type, length and tubing.
- Treating a missing label statement as a claim. “Labeling does not contain MRI safety information” means the labeling is silent, not that the set is safe or unsafe.
- Reusing a single-use set.
- Confusing an extension set with the tubing it extends. For primary gravity tubing see gravity tubing; for a set with the extension built into the catheter see the closed IV catheter system.
FAQ
What is a T-connector on an IV line?
It is the T-shaped fitting at the proximal end of an extension set, with an injection port or needle-free valve on the side. The parts are listed above.
Is a T-connector extension set the same as an IV extension set?
The extension set is the length of tubing; the T-connector is the fitting on it. In the FDA records cited here, T-connector extension sets fall under 21 CFR 880.5440, Class II, product code FPA, the same regulation as other intravascular administration sets.
Does the set have a clamp?
The K112799 summary lists a slide clamp as a component of the tubing. For how clamps work on a set, see IV roller clamps.
Sources
- eCFR, 21 CFR 880.5440, Intravascular administration set (checked 2026-10-30): ecfr.gov
- NLM AccessGUDID, BD Alaris SmartSite 20051E (checked 2026-10-30): accessgudid.nlm.nih.gov
- FDA 510(k) K112799, MED-RX Extension Set with T-Connector, decision 23 December 2011 (checked 2026-10-30): FDA data mirror
Related supplies: infusion supplies. See also PCA tubing.
