Cleared Traditional

K250545 - Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (FDA 510(k) Clearance)

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

K250545 · Surgical Instrument Service and Savings, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
100d
Days
Class 2
Risk

K250545 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultraso.... Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on June 5, 2025 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Surgical Instrument Service and Savings, Inc. devices

Submission Details

510(k) Number K250545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2025
Decision Date June 05, 2025
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 29
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K250545.
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
K250592 · Northeast Scientific, Inc. · May 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 )
K243101 · Surgical Instrument Service and Savings, Inc. · Mar 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936)
K234064 · Surgical Instrument Service and Savings, Inc. · Sep 2024
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · Stryker Sustainability Solutions · Jul 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · Abbott Medical · Jun 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023