Cleared Traditional

MODIFIED BIOLOG (K915624) - FDA 510(k) Clearance

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

K915624 · Micromedical Industries, Ltd. · Cardiovascular device
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Mar 1992
Decision
113d
Days
Class 2
Risk

K915624 is an FDA 510(k) clearance for the MODIFIED BIOLOG. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Micromedical Industries, Ltd. devices

Submission Details

510(k) Number K915624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1991
Decision Date March 27, 1992
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 55
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K915624.
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HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
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HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
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K904696 · Nihon Kohden America, Inc. · Feb 1991
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990