Cleared Traditional

TRANSDUCER ANTISEPTIC TOWELETTE (K812776) - FDA 510(k) Clearance

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

K812776 · Echo Laboratories, Inc. · Radiology device
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Jan 1982
Decision
112d
Days
Class 2
Risk

K812776 is an FDA 510(k) clearance for the TRANSDUCER ANTISEPTIC TOWELETTE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Echo Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1982 after a review of 112 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 Echo Laboratories, Inc. devices

Submission Details

510(k) Number K812776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date January 25, 1982
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
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 100
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K812776.
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K853249 · General Electric Co. · Dec 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · Hewlett-Packard Co. · Aug 1985
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
7.5 MHZ WP TRANSDUCER
K810748 · General Electric Co. · Jun 1981
5 MHZ TRANSDUCER
K810749 · General Electric Co. · Apr 1981