Cleared Traditional

K133029 - ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE (FDA 510(k) Clearance)

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

K133029 · Compression Works, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
71d
Days
Class 2
Risk

K133029 is an FDA 510(k) clearance for the ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Compression Works, LLC (Providence, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 71 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 Compression Works, LLC devices

Submission Details

510(k) Number K133029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date December 06, 2013
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 202
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K133029.
Arc Adjustable Radial Cuff Compression Device
K252772 · Tz Medical, Inc. · May 2026
Life Saving Tourniquet
K254060 · TW Medical · Apr 2026
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023