Cleared Traditional

TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT (K961368) - FDA 510(k) Clearance

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

K961368 · Vasamedics, LLC · Cardiovascular device
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Oct 1996
Decision
185d
Days
Class 2
Risk

K961368 is an FDA 510(k) clearance for the TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Vasamedics, LLC (Saint Paul, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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 Vasamedics, LLC devices

Submission Details

510(k) Number K961368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 09, 1996
Decision Date October 11, 1996
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 47
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