Cleared Traditional

TR BAND Radial Compression Device (K213531) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213531 · Terumo Medical Corporation · Cardiovascular device
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Dec 2021
Decision
45d
Days
Class 2
Risk

K213531 is an FDA 510(k) clearance for the TR BAND Radial Compression Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on December 20, 2021 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Medical Corporation devices

Submission Details

510(k) Number K213531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2021
Decision Date December 20, 2021
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 39
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K213531.
VIOLA
K230248 · Vascular Graft Solutions, Ltd. · Feb 2023
Radial Artery Compression Tourniquets
K222182 · Beijing Demax Medical Technology Co.,Ltd · Jan 2023
GEM Biover Microvascular Clamps
K221843 · Synovis Micro Companies Alliance, Inc. · Sep 2022
SiteSeal SV
K210681 · Ensite Vascular · Apr 2021
MI DeTACH
K210006 · Biorep Technologies, Inc. · Mar 2021
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
K210324 · Carefusion 2200, Inc. · Mar 2021