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Junctional Emergency Treatment Tool Model 30-0088

by North American Rescue Products, Inc.

510(k) K123194

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123194 Date3 Jan 2013ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2637-2025 FDA Class II initiated 1 Jul 2025

    Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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