Cleared Traditional

K895534 - BIOLOG

K895534 is an FDA 510(k) clearance for BIOLOG, manufactured by Micromedical. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K895534 · Micromedical · Cardiovascular device
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Mar 1990
Decision
187d
Days
Class 2
Risk

K895534 is an FDA 510(k) clearance for the BIOLOG. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Micromedical (Gettysburg, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 187 days - an extended review cycle.

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 devices

FDA 510(k) Submission Details - K895534

510(k) Number K895534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1989
Decision Date March 19, 1990
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

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 227
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K895534.
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · Marquette Electronics, Inc. · Apr 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · Datex Division Instrumentarium Corp. · Mar 1990
ERGOMED 840/ERGOMED 840L
K885085 · Burdick Corp. · Oct 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989