Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
510(k) K221661
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK221661 | Date3 Mar 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is a junctional tourniquet designed to control non-compressible hemorrhage at the abdominal aorta and pelvic junction. It applies external compression to occlude arterial bleeding when standard tourniquets are ineffective, particularly in cases involving junctional or abdominal hemorrhage.
The AAJT-S is intended for use in prehospital, emergency department, and military settings to manage severe bleeding where limb tourniquets cannot be applied. Supplied sterile and single-use, it features a stabilized tightening mechanism and advanced materials for consistent occlusion. Authorized under FDA 510(k) clearance and MDR compliance, it is classified under product code DXC and reviewed by the Cardiovascular Advisory Committee.
From the manufacturer
The AAJT-S abdominal aortic and junctional tourniquet stops non-compressible hemorrhage at the junction - trusted by EMS, hospital and military teams.
See how the AAJT-S applies external aortic compression to control abdominal, pelvic and junctional bleeding when a limb tourniquet cannot reach.
AAJT-S Abdominal Aortic Junctional Tourniquet - MED-TAC.
Other devices from Compression Works, Inc
Questions
AI-generated answers, 18 Sep 2026
What types of bleeding situations is the AAJT-S specifically designed to address, and why can’t standard tourniquets be used instead?
The AAJT-S is designed to control non-compressible hemorrhage at the abdominal aorta or pelvic junction, where standard limb tourniquets are ineffective. It applies external compression to occlude arterial bleeding in life-threatening situations like junctional or abdominal trauma, where bleeding occurs at critical vascular junctions that cannot be accessed by conventional tourniquets. This makes it essential for prehospital, emergency department, or military settings where limb tourniquets cannot be applied.
Is the AAJT-S meant for repeated use, or is it intended as a single-use device? How does this affect its sterility?
The AAJT-S is sterile and single-use only, meaning it is packaged for one-time application to ensure patient safety and infection control. This design aligns with best practices for hemorrhage control devices, where reuse could compromise sterility and efficacy. The stabilized tightening mechanism and advanced materials are optimized for a single application to guarantee consistent performance.
What settings or environments is this device approved for, and how does its stabilization feature improve its effectiveness?
The AAJT-S is authorized for use in prehospital, emergency department, and military settings, where rapid hemorrhage control is critical. Its stabilized tightening mechanism ensures consistent and reliable compression, reducing the risk of slippage or improper occlusion—especially in high-stress environments like trauma or combat. This feature helps clinicians achieve effective arterial occlusion even in unstable or dynamic conditions.
How is the AAJT-S supplied, and are there different sizes or models available to accommodate various patient anatomies?
The AAJT-S is supplied sterile and pre-packaged for single-use, ensuring readiness for immediate deployment. While the provided data does not specify multiple sizes or models, its design is intended to address abdominal aorta and pelvic junction hemorrhage, suggesting a standardized fit for adult patients. For pediatric or specialized cases, additional sizing may be required, but this would need to be confirmed with the manufacturer.