Cleared Traditional

K852132 - MODEL 21225A CW COPPLER/IMAGING TRANSDUCER

K852132 is the FDA 510(k) clearance for MODEL 21225A CW COPPLER/IMAGING TRANSDUCER by Hewlett-Packard Co.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K852132 · Hewlett-Packard Co. · Radiology device
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Aug 1985
Decision
95d
Days
Class 2
Risk

K852132 is an FDA 510(k) clearance for the MODEL 21225A CW COPPLER/IMAGING TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 95 days - within the typical 510(k) review window.

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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K852132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1985
Decision Date August 19, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 107d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K852132.
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