Cleared Traditional

ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (K942770) - FDA 510(k) Clearance

Class I General Hospital device.

K942770 · Ultimate Development Corp. · General Hospital
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Dec 1994
Decision
193d
Days
Class 1
Risk

K942770 is an FDA 510(k) clearance for the ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Ultimate Development Corp. (Tulsa, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 193 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 Ultimate Development Corp. devices

Submission Details

510(k) Number K942770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date December 23, 1994
Days to Decision 193 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 129d · This submission: 193d
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.