Cleared Traditional

K223139 - Wallaby 017 Micro Catheter

K223139 is an FDA 510(k) clearance for Wallaby 017 Micro Catheter, manufactured by Wallaby Medical. The device is a Class 2 Neurology device with product code KRA cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K223139 · Wallaby Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
203d
Days
Class 2
Risk

K223139 is an FDA 510(k) clearance for the Wallaby 017 Micro Catheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on April 25, 2023 after a review of 203 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1210 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallaby Medical devices

FDA 510(k) Submission Details - K223139

510(k) Number K223139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2022
Decision Date April 25, 2023
Days to Decision 203 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 148d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Neurology devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K223139.
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