Cleared Traditional

K854950 - BED PATIENT MONITOR

K854950 is an FDA 510(k) clearance for BED PATIENT MONITOR, manufactured by Clearview Electronics Corp.. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K854950 · Clearview Electronics Corp. · General Hospital
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Mar 1986
Decision
105d
Days
Class 1
Risk

K854950 is an FDA 510(k) clearance for the BED PATIENT MONITOR. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Clearview Electronics Corp. (Newark, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 105 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 Clearview Electronics Corp. devices

FDA 510(k) Submission Details - K854950

510(k) Number K854950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date March 25, 1986
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

KMI Device Classification - Class 1, General Controls

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.