Cleared Traditional

THE MONITOR ELECTRONIC BED ALARM SYSTEM (K901330) - FDA 510(k) Clearance

Class I General Hospital device.

K901330 · The Monitor Corp. · General Hospital
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Aug 1990
Decision
161d
Days
Class 1
Risk

K901330 is an FDA 510(k) clearance for the THE MONITOR ELECTRONIC BED ALARM SYSTEM. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by The Monitor Corp. (Dallas, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all The Monitor Corp. devices

Submission Details

510(k) Number K901330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date August 30, 1990
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.