Cleared Traditional

K934638 - REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A

K934638 is an FDA 510(k) clearance for REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, manufactured by Koven Technology, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K934638 · Koven Technology, Inc. · Cardiovascular device
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May 1994
Decision
231d
Days
Class 2
Risk

K934638 is an FDA 510(k) clearance for the REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 13, 1994 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Koven Technology, Inc. devices

FDA 510(k) Submission Details - K934638

510(k) Number K934638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date May 13, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 38
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K934638.
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