Cleared Traditional

TEE PROBE (K953579) - FDA 510(k) Clearance

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

K953579 · Biosound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
185d
Days
Class 2
Risk

K953579 is an FDA 510(k) clearance for the TEE PROBE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 2, 1996 after a review of 185 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 Biosound, Inc. devices

Submission Details

510(k) Number K953579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date February 02, 1996
Days to Decision 185 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
78d slower than avg
Panel avg: 107d · This submission: 185d
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 94
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K953579.
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · Toshiba America Medical Systems, In.C · Mar 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · Toshiba America Medical Systems, In.C · Mar 1997
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · Olympus America, Inc. · Feb 1996
GE B510 TRANSDUCER
K951723 · GE Medical Systems · Nov 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · Olympus America, Inc. · Jun 1995
OLYMPUS ULTRASONIC PROBES
K944610 · Olympus America, Inc. · Apr 1995