Cleared Traditional

WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) (K901619) - FDA 510(k) Clearance

K901619 · Wex Medical Instrumentation Co. · Cardiovascular device
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Sep 1991
Decision
517d
Days
-
Risk

K901619 is an FDA 510(k) clearance for the WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L).

Submitted by Wex Medical Instrumentation Co. (Jamaica, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 517 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Wex Medical Instrumentation Co. devices

Submission Details

510(k) Number K901619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1990
Decision Date September 05, 1991
Days to Decision 517 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 125d · This submission: 517d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K901619.
ECG FAX MODEM
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PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · Hewlett-Packard Co. · Jul 1990
Q750 ELECTROCARDIOGRAPH
K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987