Cleared Traditional

ULTRASOUND PROBE DRAPE (K940151) - FDA 510(k) Clearance

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

K940151 · Hydro-Med Products, Inc. · Radiology device
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Nov 1994
Decision
315d
Days
Class 2
Risk

K940151 is an FDA 510(k) clearance for the ULTRASOUND PROBE DRAPE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on November 14, 1994 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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. Elevated predicate reliance profile. 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 Hydro-Med Products, Inc. devices

Submission Details

510(k) Number K940151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date November 14, 1994
Days to Decision 315 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 107d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K940151.
SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)
K952540 · Hewlett-Packard Co. · Mar 1996
SIEMENS SONOLINE 4XX
K946179 · Siemens Medical Solutions USA, Inc. · Oct 1995
PVK-357AT
K943303 · Toshiba America Medical Systems, In.C · Feb 1995
HP 77010CF
K943634 · Hewlett-Packard Co. · Sep 1994
CAPASEE
K933747 · Toshiba America Medical Systems, In.C · May 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · GE Medical Systems · Mar 1994