Cleared Traditional

PERCEPTOR COMPENSATOR MORSE MANIFOLD (K951722) - FDA 510(k) Clearance

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

K951722 · Namic · Cardiovascular device
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Mar 1996
Decision
346d
Days
Class 2
Risk

K951722 is an FDA 510(k) clearance for the PERCEPTOR COMPENSATOR MORSE MANIFOLD. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Namic (Glens Falls, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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. Elevated predicate reliance profile. 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 Namic devices

Submission Details

510(k) Number K951722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date March 25, 1996
Days to Decision 346 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
221d slower than avg
Panel avg: 125d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 147
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