Cleared Traditional

K123194 - JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088

K123194 is an FDA 510(k) clearance for JUNCTIONAL EMERGENCY TREATMENT TOOL MOD..., manufactured by North American Rescue Products, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K123194 · North American Rescue Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
84d
Days
Class 2
Risk

K123194 is an FDA 510(k) clearance for the JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by North American Rescue Products, Inc. (Greer, US). The FDA issued a Cleared decision on January 3, 2013 after a review of 84 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.

FDA 510(k) Submission Details - K123194

510(k) Number K123194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2012
Decision Date January 03, 2013
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

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 193
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K123194.
COMBAT READY CLAMP
K130482 · Combat Medical Systems, LLC · Apr 2013
CATALYST II AND III
K130124 · Cardiva Medical, Inc. · Mar 2013
SAM JUNCTIONAL TOURNIQUET
K123694 · Sam Medical Products · Mar 2013
SEAL ONE
K123035 · Perouse Medical · Nov 2012
AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · Datascope Corp., Cardiac Assist Division · Nov 2012
K2 MEDICAL VASCULAR CLAMPS
K120492 · K2 Medical GmbH & Co. KG · Apr 2012
K123194 · JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
Download PDF FDA Summary North American Rescue…