TR Band Radial Compression Device: Parts and FDA Class

A TR Band is a wrist compression device used to help stop bleeding at the radial artery after a transradial procedure. Readers here are usually clinic staff, buyers or students who need to know what the device is made of, how FDA classifies it, and what its manufacturer labels it for. It is one branded example of a wider class called radial compression devices (also called radial compression bands).

What a radial compression band is

A radial compression band is a device cleared by FDA to assist hemostasis (control of bleeding) of the radial artery after a transradial procedure. In the FDA 510(k) summary for the Terumo TR Band (K152525, cleared November 10, 2015), the indication reads: a compression device to assist hemostasis of the radial artery after a transradial procedure. “TR Band” is the manufacturer’s brand name; this page uses it as the example product and uses “radial compression band” for the general class.

Who uses it: clinicians and procedural staff who work with transradial (wrist-access) procedures, and the staff who stock and manage those supplies.

Parts and construction

FDA’s summary describes the TR Band as a tourniquet-style device made of a plastic belt with a hook-and-loop adjustable fastener on each end, two compression balloons and an injection port. It also includes a dedicated inflator.

Part	What the FDA summary says
Belt	Plastic belt with a hook-and-loop adjustable fastener on each end; belt and balloons are clear so the site can be viewed.
Compression balloons	Two balloons (one large, one small) that are filled at the same time through a single air injection port.
Injection port	Has a valve that keeps air in the balloons.
Support plate	Sits over the two balloons so the balloons and belt conform to the wrist contour.
Inflator	A specially designed 20 ml syringe for use only with the TR Band; it is not a patient-contacting part. Air volume can be reduced or increased to adjust pressure.

How FDA classifies it

Item	Detail (FDA, K152525)
Regulation	21 CFR 870.4450, “Vascular clamp”
Device class	Class II
Product code / panel	DXC / Cardiovascular
Common name in the 510(k)	Radial compression device
Predicate	K070423; the indication is identical to the predicate’s
Use and sterility	Disposable, single use only; individually packaged; ethylene oxide sterilized to a sterility assurance level of 10-6 (ISO 11135)
Biocompatibility category	Surface device, breached or compromised surface, limited contact (under 24 hours)

FDA lists this product under the vascular clamp regulation, which is why a wrist band carries that name in its records. For background on the terms, see sterility assurance level and FDA-recognized consensus standards. The 510(k) contained no clinical data, so it does not report outcomes.

Types and variants

The key distinction is brand versus class: the TR Band is one product in the radial compression device class, and it was cleared against a predicate (K070423) with the same indication. Other manufacturers’ bands are cleared on their own 510(k) records, so check each record for that product’s construction.

How the manufacturer describes use

Terumo publishes an application and removal poster (RX only, PM-05988, 2022) for trained clinical staff. It states that the product labels and package insert hold the complete warnings, precautions, potential complications and instructions for use. Volumes and timings in such materials are clinical parameters that can differ between markets, so they are not reproduced here; follow the instructions for use supplied with the product.

How to choose

Criteria that the FDA summary and manufacturer labelling support:

• Check that the labelled indication matches the use: the TR Band is indicated to assist hemostasis of the radial artery after a transradial procedure.
• Confirm the pack is a single-use, individually packaged sterile device, as the 510(k) describes.
• Confirm the correct dedicated inflator is included; FDA describes the TR Band inflator as for use only with the TR Band.
• Read the manufacturer’s current instructions for use for the exact product in question.

Safe use and handling basics

• Single use only: the FDA summary describes a disposable device intended for single use.
• It is supplied sterile in individual packaging, so keep the package intact until use.
• Use the band only as its instructions for use direct, and by trained clinical staff.
• Device problems can be reported to FDA; see medical device reporting.

Common mistakes

• Treating “TR Band” as the name of the whole class; it is a brand within the radial compression device class.
• Reusing a band or inflator labelled single use.
• Pairing the band with an inflator not designed for it.
• Copying inflation or deflation figures from one market’s poster to another instead of following the instructions for use that ship with the product.

FAQ

What is a TR Band?

It is Terumo’s brand of radial compression device: a belt with two balloons, an injection port and a dedicated inflator, cleared by FDA to assist hemostasis of the radial artery after a transradial procedure.

Is a TR Band single use?

Yes. The FDA 510(k) summary (K152525) describes it as a disposable device intended for single use only, supplied individually packaged and ethylene oxide sterilized.

How does FDA classify a radial compression device?

The TR Band is Class II under 21 CFR 870.4450 (vascular clamp), product code DXC, cardiovascular panel.

Related supplies are listed in the emergency and trauma supplies category at lac.us. Another clamp-type device is explained in what is a hemostat.

Sources

• FDA 510(k) K152525 letter and summary, Terumo TR Band, cleared November 10, 2015: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152525.pdf (checked 2026-10-30).
• Terumo, Standard application and removal guidelines poster, PM-05988, 2022: https://www.terumois.com/en-us/product/tr-band/documents/tr-band-poster.pdf (checked 2026-10-30).
• 21 CFR 870.4450, vascular clamp: https://www.law.cornell.edu/cfr/text/21/870.4450 (checked 2026-10-30).