Cleared Traditional

K944497 - UNILECT, MONITAB AND BIOTRACE-HR

K944497 is an FDA 510(k) clearance for UNILECT, manufactured by Msb , Ltd.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 612-day FDA review.

K944497 · Msb , Ltd. · Cardiovascular device
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May 1996
Decision
612d
Days
Class 2
Risk

K944497 is an FDA 510(k) clearance for the UNILECT, MONITAB AND BIOTRACE-HR. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Msb , Ltd. (Marlborough, Wiltshire, GB). The FDA issued a Cleared decision on May 17, 1996 after a review of 612 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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: 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 Msb , Ltd. devices

FDA 510(k) Submission Details - K944497

510(k) Number K944497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date May 17, 1996
Days to Decision 612 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
487d slower than avg
Panel avg: 125d · This submission: 612d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 157
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K944497.
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CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996