Cleared Traditional

K850137 - TECA TC2-64 TRANSCRANIAL DOPPLER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850137 · Teca, Inc. · Cardiovascular device
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Aug 1985
Decision
212d
Days
Class 2
Risk

K850137 is an FDA 510(k) clearance for the TECA TC2-64 TRANSCRANIAL DOPPLER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on August 14, 1985 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Teca, Inc. devices

Submission Details

510(k) Number K850137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date August 14, 1985
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 136
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