Cleared Traditional

K935994 - PW DOPPLER VASCULAR PROBES

K935994 is an FDA 510(k) clearance for PW DOPPLER VASCULAR PROBES, manufactured by Koven Technology, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K935994 · Koven Technology, Inc. · Radiology device
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May 1995
Decision
512d
Days
Class 2
Risk

K935994 is an FDA 510(k) clearance for the PW DOPPLER VASCULAR PROBES. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Koven Technology, Inc. devices

FDA 510(k) Submission Details - K935994

510(k) Number K935994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date May 11, 1995
Days to Decision 512 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
405d slower than avg
Panel avg: 107d · This submission: 512d
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 229
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K935994.
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