Cleared Traditional

K161408 - Compass Cast and MAP

K161408 is the FDA 510(k) clearance for Compass Cast and MAP by Centurion Medical Products Corporation. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K161408 · Centurion Medical Products Corporation · Cardiovascular device
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Nov 2016
Decision
186d
Days
Class 2
Risk

K161408 is an FDA 510(k) clearance for the Compass Cast and MAP. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Centurion Medical Products Corporation (Williamston, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 186 days - an extended review cycle.

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. 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 Centurion Medical Products Corporation devices

Submission Details

510(k) Number K161408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2016
Decision Date November 22, 2016
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
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 71
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