Cleared Traditional

ALERT BED ALARM SYSTEM (K901969) - FDA 510(k) Clearance

Class I General Hospital device.

K901969 · Alertronics, Inc. · General Hospital
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Sep 1990
Decision
134d
Days
Class 1
Risk

K901969 is an FDA 510(k) clearance for the ALERT BED ALARM SYSTEM. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Alertronics, Inc. (Tulsa, US). The FDA issued a Cleared decision on September 12, 1990 after a review of 134 days - within the typical 510(k) review window.

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 Alertronics, Inc. devices

Submission Details

510(k) Number K901969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date September 12, 1990
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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.