Cleared Traditional

THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR (K850657) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K850657 · Flowtronics, Inc. · Neurology device
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Feb 1985
Decision
25d
Days
Class 3
Risk

K850657 is an FDA 510(k) clearance for the THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR. Classified as Monitor, Blood-flow, Cerebral, Thermal Diffusion (product code LME), Class III - Premarket Approval.

Submitted by Flowtronics, Inc. (Phoenix, US). The FDA issued a Cleared decision on February 22, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. 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. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Flowtronics, Inc. devices

Submission Details

510(k) Number K850657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date February 22, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 148d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LME Monitor, Blood-flow, Cerebral, Thermal Diffusion
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.