Cleared Traditional

K242966 - Gentuity HF-OCT Imaging System with Vis...

K242966 is an FDA 510(k) clearance for Gentuity HF-OCT Imaging System with Vis..., manufactured by Gentuity, LLC. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K242966 · Gentuity, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
127d
Days
Class 2
Risk

K242966 is an FDA 510(k) clearance for the Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on January 31, 2025 after a review of 127 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 Gentuity, LLC devices

FDA 510(k) Submission Details - K242966

510(k) Number K242966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date January 31, 2025
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K242966.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
K252702 · Bioptimal International Pte. , Ltd. · May 2026
Arterial Pressure Monitoring Set/Tray
K254278 · Spectrum Vascular · Mar 2026
DualView Catheter
K250751 · Terumo Corporation · Jul 2025
pNOVUS 21 Microcatheter
K242420 · Phenox, Ltd. · Nov 2024
Impress Angiographic Catheter
K233268 · Merit Medical Systems, Inc. · May 2024
Zoom 6F Insert Catheters
K233975 · Imperative Care, Inc. · Apr 2024