Cleared Traditional

K983985 - HYBRISONIC SHEATH

K983985 is an FDA 510(k) clearance for HYBRISONIC SHEATH, manufactured by Sonotech, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K983985 · Sonotech, Inc. · Radiology device
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Feb 1999
Decision
108d
Days
Class 2
Risk

K983985 is an FDA 510(k) clearance for the HYBRISONIC SHEATH. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on February 25, 1999 after a review of 108 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 Sonotech, Inc. devices

FDA 510(k) Submission Details - K983985

510(k) Number K983985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date February 25, 1999
Days to Decision 108 days
Submission Type Traditional
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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 284
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K983985.
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