Cleared Traditional

K254051 - Extroducer Infusion Catheter System

K254051 is an FDA 510(k) clearance for Extroducer Infusion Catheter System, manufactured by SmartWise Sweden AB. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K254051 · SmartWise Sweden AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
268d
Days
Class 2
Risk

K254051 is an FDA 510(k) clearance for the Extroducer Infusion Catheter System. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by SmartWise Sweden AB (Tullinge, SE). The FDA issued a Cleared decision on September 11, 2026 after a review of 268 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 SmartWise Sweden AB devices

FDA 510(k) Submission Details - K254051

510(k) Number K254051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2025
Decision Date September 11, 2026
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 161
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K254051.
TriSalus TriNav Advance Infusion System
K253509 · Trisalus Life Sciences · Sep 2026
Verge™ Microcatheter
K261610 · Instylla, Inc. · Jun 2026
TruSelect™ 2.6 Microcatheter
K260771 · Boston Scientific Corporation · May 2026
InVera Infusion Device
K250794 · Invera Medical · Mar 2026
Micro Catheter
K243534 · Suzhou Zenith Vascular SciTech Limited · Jul 2025
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
K231821 · Transit Scientific, LLC · Nov 2023