Cleared Traditional

K951722 - PERCEPTOR COMPENSATOR MORSE MANIFOLD

K951722 is an FDA 510(k) clearance for PERCEPTOR COMPENSATOR MORSE MANIFOLD, manufactured by Namic. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 346-day FDA review.

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

FDA 510(k) Submission Details - K951722

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
Combination Product No
PCCP Authorized No
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.

DRS Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K951722.
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K981747 · Sunscope Intl., Inc. · Aug 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
K981745 · Sunscope Intl., Inc. · Jul 1998
MX960 REUSABLE PRESSURE TRANSDUCER
K961404 · Medex, Inc. · Jun 1996
NOVATRANS II
K951129 · Medex, Inc. · Apr 1995
COBE PATIENT MONITORING PRODUCTS
K921343 · Cobe Cardiovascular, Inc. · Jan 1993
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · Merit Medical Systems, Inc. · Dec 1992