Cleared Special

K031894 - SCANTEC PAD

K031894 is an FDA 510(k) clearance for SCANTEC PAD, manufactured by Sonotech, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Special 510(k) pathway after a 29-day FDA review.

K031894 · Sonotech, Inc. · Radiology device

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Jul 2003

Decision

29d

Days

Class 2

Risk

K031894 is an FDA 510(k) clearance for the SCANTEC PAD. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031894

510(k) Number	K031894 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 2003
Decision Date	July 18, 2003
Days to Decision	29 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

78d faster than avg

Panel avg: 107d · This submission: 29d

Pathway characteristics

Modification to existing cleared device.

MUI Device Classification - Class 2, Special Controls

Product Code	MUI Media, Coupling, Ultrasound
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 - MUI Media, Coupling, Ultrasound

All 33

Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K031894.

ULTRABIO

K033178 · Sonotech, Inc. · Aug 2004

AUTOGEL PAD

K031018 · Rich-Mar Corp. · Dec 2003

SCANLUBE

K031222 · Sonotech, Inc. · Jul 2003

ULTRAEKOGEL MODELS EK 2000 & EK 2001

K030889 · Inmed Ltda. · May 2003

VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA

K020956 · Microtek Medical, Inc. · May 2002

UNI-PATCH ULTRASOUND COUPLING GEL

K021132 · The Ludlow Company LP · May 2002

FDA 510(k) Resources - Radiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K031894

Sonotech, Inc.

Bellingham, WA · US

MARGARET J LARSON

Regulatory profile

14 submissions 14 cleared

100% clearance rate · Active in Radiology

View all devices by Sonotech, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 18, 2003. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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