Cleared Traditional

K250632 - Arctx Cool Catheter Set (FDA 510(k) Clearance)

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

K250632 · Arctx Medical · Cardiovascular device
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Oct 2025
Decision
241d
Days
Class 2
Risk

K250632 is an FDA 510(k) clearance for the Arctx Cool Catheter Set. Classified as Esophageal Thermal Regulation And Gastric Suctioning Device (product code PLA), Class II - Special Controls.

Submitted by Arctx Medical (Raleigh, US). The FDA issued a Cleared decision on October 30, 2025 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5910 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Arctx Medical devices

Submission Details

510(k) Number K250632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2025
Decision Date October 30, 2025
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5910
Definition The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage.
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 Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.