Cleared Traditional

K254071 - p17 XR Microcatheter

K254071 is an FDA 510(k) clearance for p17 XR Microcatheter, manufactured by Wallaby Medical. The device is a Class 2 Neurology device with product code QJP cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K254071 · Wallaby Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
243d
Days
Class 2
Risk

K254071 is an FDA 510(k) clearance for the p17 XR Microcatheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on August 18, 2026 after a review of 243 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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 - K254071

510(k) Number K254071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2025
Decision Date August 18, 2026
Days to Decision 243 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 148d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJP Device Classification - Class 2, Special Controls

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 96
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K254071.
Zoom 4S Catheter
K261176 · Imperative Care, Inc. · Aug 2026
SLIM Microcatheter
K260199 · Balt USA, LLC · Jul 2026
Millipede88 Access Catheter
K253901 · Perfuze, Ltd. · Jul 2026
Trevo Trak 21 Microcatheter
K261889 · Stryker Neurovascular · Jul 2026
BOBBY Balloon Guide Catheter
K261549 · MicroVention, Inc., d/b/a Terumo Neuro · Jun 2026
Zenith Distal Access Long Sheath
K253359 · Suzhou Zenith Vascular SciTech Limited · May 2026