Cleared Traditional

K925078 - SPECTRADOP

K925078 is an FDA 510(k) clearance for SPECTRADOP, manufactured by Bennett and Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 1013-day FDA review.

K925078 · Bennett and Assoc., Inc. · Cardiovascular device
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Jul 1995
Decision
1013d
Days
Class 2
Risk

K925078 is an FDA 510(k) clearance for the SPECTRADOP. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Bennett and Assoc., Inc. (Cambridge, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 1013 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Cardiovascular submissions.

View all Bennett and Assoc., Inc. devices

FDA 510(k) Submission Details - K925078

510(k) Number K925078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date July 17, 1995
Days to Decision 1013 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
888d slower than avg
Panel avg: 125d · This submission: 1013d
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 55
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K925078.
FALCON
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