Cleared Traditional

K201425 - Disposable Intraoperative Probe (DIOP8)

K201425 is an FDA 510(k) clearance for Disposable Intraoperative Probe (DIOP8), manufactured by Huntleigh Healthcare Limited. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K201425 · Huntleigh Healthcare Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
266d
Days
Class 2
Risk

K201425 is an FDA 510(k) clearance for the Disposable Intraoperative Probe (DIOP8). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Huntleigh Healthcare Limited (Cardiff, GB). The FDA issued a Cleared decision on February 19, 2021 after a review of 266 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Huntleigh Healthcare Limited devices

FDA 510(k) Submission Details - K201425

510(k) Number K201425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date February 19, 2021
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 226
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K201425.
Natural Rubber Latex Ultrasound Transducer Probe Covers
K213087 · Global Protection Corp. · Jun 2022
CIV-Clear cover
K211270 · CIVCO Medical Instruments Co., Inc. · Sep 2021
EMM Ultrasonic Transducer Cover
K211969 · Exact Medical Manufacturing · Aug 2021
Vscan Air
K202035 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2020
EZ-Cover
K191491 · Medxpress.Pro · Jun 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · Boston Scientific Corporation · Apr 2020